Journal of Clinical and Diagnostic Research, ISSN - 0973 - 709X

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Dr Mohan Z Mani

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Believers Church Medical College,
Thiruvalla, Kerala
On Sep 2018




Prof. Somashekhar Nimbalkar

"Over the last few years, we have published our research regularly in Journal of Clinical and Diagnostic Research. Having published in more than 20 high impact journals over the last five years including several high impact ones and reviewing articles for even more journals across my fields of interest, we value our published work in JCDR for their high standards in publishing scientific articles. The ease of submission, the rapid reviews in under a month, the high quality of their reviewers and keen attention to the final process of proofs and publication, ensure that there are no mistakes in the final article. We have been asked clarifications on several occasions and have been happy to provide them and it exemplifies the commitment to quality of the team at JCDR."



Prof. Somashekhar Nimbalkar
Head, Department of Pediatrics, Pramukhswami Medical College, Karamsad
Chairman, Research Group, Charutar Arogya Mandal, Karamsad
National Joint Coordinator - Advanced IAP NNF NRP Program
Ex-Member, Governing Body, National Neonatology Forum, New Delhi
Ex-President - National Neonatology Forum Gujarat State Chapter
Department of Pediatrics, Pramukhswami Medical College, Karamsad, Anand, Gujarat.
On Sep 2018




Dr. Kalyani R

"Journal of Clinical and Diagnostic Research is at present a well-known Indian originated scientific journal which started with a humble beginning. I have been associated with this journal since many years. I appreciate the Editor, Dr. Hemant Jain, for his constant effort in bringing up this journal to the present status right from the scratch. The journal is multidisciplinary. It encourages in publishing the scientific articles from postgraduates and also the beginners who start their career. At the same time the journal also caters for the high quality articles from specialty and super-specialty researchers. Hence it provides a platform for the scientist and researchers to publish. The other aspect of it is, the readers get the information regarding the most recent developments in science which can be used for teaching, research, treating patients and to some extent take preventive measures against certain diseases. The journal is contributing immensely to the society at national and international level."



Dr Kalyani R
Professor and Head
Department of Pathology
Sri Devaraj Urs Medical College
Sri Devaraj Urs Academy of Higher Education and Research , Kolar, Karnataka
On Sep 2018




Dr. Saumya Navit

"As a peer-reviewed journal, the Journal of Clinical and Diagnostic Research provides an opportunity to researchers, scientists and budding professionals to explore the developments in the field of medicine and dentistry and their varied specialities, thus extending our view on biological diversities of living species in relation to medicine.
‘Knowledge is treasure of a wise man.’ The free access of this journal provides an immense scope of learning for the both the old and the young in field of medicine and dentistry as well. The multidisciplinary nature of the journal makes it a better platform to absorb all that is being researched and developed. The publication process is systematic and professional. Online submission, publication and peer reviewing makes it a user-friendly journal.
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I wish JCDR a great success and I hope that journal will soar higher with the passing time."



Dr Saumya Navit
Professor and Head
Department of Pediatric Dentistry
Saraswati Dental College
Lucknow
On Sep 2018




Dr. Arunava Biswas

"My sincere attachment with JCDR as an author as well as reviewer is a learning experience . Their systematic approach in publication of article in various categories is really praiseworthy.
Their prompt and timely response to review's query and the manner in which they have set the reviewing process helps in extracting the best possible scientific writings for publication.
It's a honour and pride to be a part of the JCDR team. My very best wishes to JCDR and hope it will sparkle up above the sky as a high indexed journal in near future."



Dr. Arunava Biswas
MD, DM (Clinical Pharmacology)
Assistant Professor
Department of Pharmacology
Calcutta National Medical College & Hospital , Kolkata




Dr. C.S. Ramesh Babu
" Journal of Clinical and Diagnostic Research (JCDR) is a multi-specialty medical and dental journal publishing high quality research articles in almost all branches of medicine. The quality of printing of figures and tables is excellent and comparable to any International journal. An added advantage is nominal publication charges and monthly issue of the journal and more chances of an article being accepted for publication. Moreover being a multi-specialty journal an article concerning a particular specialty has a wider reach of readers of other related specialties also. As an author and reviewer for several years I find this Journal most suitable and highly recommend this Journal."
Best regards,
C.S. Ramesh Babu,
Associate Professor of Anatomy,
Muzaffarnagar Medical College,
Muzaffarnagar.
On Aug 2018




Dr. Arundhathi. S
"Journal of Clinical and Diagnostic Research (JCDR) is a reputed peer reviewed journal and is constantly involved in publishing high quality research articles related to medicine. Its been a great pleasure to be associated with this esteemed journal as a reviewer and as an author for a couple of years. The editorial board consists of many dedicated and reputed experts as its members and they are doing an appreciable work in guiding budding researchers. JCDR is doing a commendable job in scientific research by promoting excellent quality research & review articles and case reports & series. The reviewers provide appropriate suggestions that improve the quality of articles. I strongly recommend my fraternity to encourage JCDR by contributing their valuable research work in this widely accepted, user friendly journal. I hope my collaboration with JCDR will continue for a long time".



Dr. Arundhathi. S
MBBS, MD (Pathology),
Sanjay Gandhi institute of trauma and orthopedics,
Bengaluru.
On Aug 2018




Dr. Mamta Gupta,
"It gives me great pleasure to be associated with JCDR, since last 2-3 years. Since then I have authored, co-authored and reviewed about 25 articles in JCDR. I thank JCDR for giving me an opportunity to improve my own skills as an author and a reviewer.
It 's a multispecialty journal, publishing high quality articles. It gives a platform to the authors to publish their research work which can be available for everyone across the globe to read. The best thing about JCDR is that the full articles of all medical specialties are available as pdf/html for reading free of cost or without institutional subscription, which is not there for other journals. For those who have problem in writing manuscript or do statistical work, JCDR comes for their rescue.
The journal has a monthly publication and the articles are published quite fast. In time compared to other journals. The on-line first publication is also a great advantage and facility to review one's own articles before going to print. The response to any query and permission if required, is quite fast; this is quite commendable. I have a very good experience about seeking quick permission for quoting a photograph (Fig.) from a JCDR article for my chapter authored in an E book. I never thought it would be so easy. No hassles.
Reviewing articles is no less a pain staking process and requires in depth perception, knowledge about the topic for review. It requires time and concentration, yet I enjoy doing it. The JCDR website especially for the reviewers is quite user friendly. My suggestions for improving the journal is, more strict review process, so that only high quality articles are published. I find a a good number of articles in Obst. Gynae, hence, a new journal for this specialty titled JCDR-OG can be started. May be a bimonthly or quarterly publication to begin with. Only selected articles should find a place in it.
An yearly reward for the best article authored can also incentivize the authors. Though the process of finding the best article will be not be very easy. I do not know how reviewing process can be improved. If an article is being reviewed by two reviewers, then opinion of one can be communicated to the other or the final opinion of the editor can be communicated to the reviewer if requested for. This will help one’s reviewing skills.
My best wishes to Dr. Hemant Jain and all the editorial staff of JCDR for their untiring efforts to bring out this journal. I strongly recommend medical fraternity to publish their valuable research work in this esteemed journal, JCDR".



Dr. Mamta Gupta
Consultant
(Ex HOD Obs &Gynae, Hindu Rao Hospital and associated NDMC Medical College, Delhi)
Aug 2018




Dr. Rajendra Kumar Ghritlaharey

"I wish to thank Dr. Hemant Jain, Editor-in-Chief Journal of Clinical and Diagnostic Research (JCDR), for asking me to write up few words.
Writing is the representation of language in a textual medium i e; into the words and sentences on paper. Quality medical manuscript writing in particular, demands not only a high-quality research, but also requires accurate and concise communication of findings and conclusions, with adherence to particular journal guidelines. In medical field whether working in teaching, private, or in corporate institution, everyone wants to excel in his / her own field and get recognised by making manuscripts publication.


Authors are the souls of any journal, and deserve much respect. To publish a journal manuscripts are needed from authors. Authors have a great responsibility for producing facts of their work in terms of number and results truthfully and an individual honesty is expected from authors in this regards. Both ways its true "No authors-No manuscripts-No journals" and "No journals–No manuscripts–No authors". Reviewing a manuscript is also a very responsible and important task of any peer-reviewed journal and to be taken seriously. It needs knowledge on the subject, sincerity, honesty and determination. Although the process of reviewing a manuscript is a time consuming task butit is expected to give one's best remarks within the time frame of the journal.
Salient features of the JCDR: It is a biomedical, multidisciplinary (including all medical and dental specialities), e-journal, with wide scope and extensive author support. At the same time, a free text of manuscript is available in HTML and PDF format. There is fast growing authorship and readership with JCDR as this can be judged by the number of articles published in it i e; in Feb 2007 of its first issue, it contained 5 articles only, and now in its recent volume published in April 2011, it contained 67 manuscripts. This e-journal is fulfilling the commitments and objectives sincerely, (as stated by Editor-in-chief in his preface to first edition) i e; to encourage physicians through the internet, especially from the developing countries who witness a spectrum of disease and acquire a wealth of knowledge to publish their experiences to benefit the medical community in patients care. I also feel that many of us have work of substance, newer ideas, adequate clinical materials but poor in medical writing and hesitation to submit the work and need help. JCDR provides authors help in this regards.
Timely publication of journal: Publication of manuscripts and bringing out the issue in time is one of the positive aspects of JCDR and is possible with strong support team in terms of peer reviewers, proof reading, language check, computer operators, etc. This is one of the great reasons for authors to submit their work with JCDR. Another best part of JCDR is "Online first Publications" facilities available for the authors. This facility not only provides the prompt publications of the manuscripts but at the same time also early availability of the manuscripts for the readers.
Indexation and online availability: Indexation transforms the journal in some sense from its local ownership to the worldwide professional community and to the public.JCDR is indexed with Embase & EMbiology, Google Scholar, Index Copernicus, Chemical Abstracts Service, Journal seek Database, Indian Science Abstracts, to name few of them. Manuscriptspublished in JCDR are available on major search engines ie; google, yahoo, msn.
In the era of fast growing newer technologies, and in computer and internet friendly environment the manuscripts preparation, submission, review, revision, etc and all can be done and checked with a click from all corer of the world, at any time. Of course there is always a scope for improvement in every field and none is perfect. To progress, one needs to identify the areas of one's weakness and to strengthen them.
It is well said that "happy beginning is half done" and it fits perfectly with JCDR. It has grown considerably and I feel it has already grown up from its infancy to adolescence, achieving the status of standard online e-journal form Indian continent since its inception in Feb 2007. This had been made possible due to the efforts and the hard work put in it. The way the JCDR is improving with every new volume, with good quality original manuscripts, makes it a quality journal for readers. I must thank and congratulate Dr Hemant Jain, Editor-in-Chief JCDR and his team for their sincere efforts, dedication, and determination for making JCDR a fast growing journal.
Every one of us: authors, reviewers, editors, and publisher are responsible for enhancing the stature of the journal. I wish for a great success for JCDR."



Thanking you
With sincere regards
Dr. Rajendra Kumar Ghritlaharey, M.S., M. Ch., FAIS
Associate Professor,
Department of Paediatric Surgery, Gandhi Medical College & Associated
Kamla Nehru & Hamidia Hospitals Bhopal, Madhya Pradesh 462 001 (India)
E-mail: drrajendrak1@rediffmail.com
On May 11,2011




Dr. Shankar P.R.

"On looking back through my Gmail archives after being requested by the journal to write a short editorial about my experiences of publishing with the Journal of Clinical and Diagnostic Research (JCDR), I came across an e-mail from Dr. Hemant Jain, Editor, in March 2007, which introduced the new electronic journal. The main features of the journal which were outlined in the e-mail were extensive author support, cash rewards, the peer review process, and other salient features of the journal.
Over a span of over four years, we (I and my colleagues) have published around 25 articles in the journal. In this editorial, I plan to briefly discuss my experiences of publishing with JCDR and the strengths of the journal and to finally address the areas for improvement.
My experiences of publishing with JCDR: Overall, my experiences of publishing withJCDR have been positive. The best point about the journal is that it responds to queries from the author. This may seem to be simple and not too much to ask for, but unfortunately, many journals in the subcontinent and from many developing countries do not respond or they respond with a long delay to the queries from the authors 1. The reasons could be many, including lack of optimal secretarial and other support. Another problem with many journals is the slowness of the review process. Editorial processing and peer review can take anywhere between a year to two years with some journals. Also, some journals do not keep the contributors informed about the progress of the review process. Due to the long review process, the articles can lose their relevance and topicality. A major benefit with JCDR is the timeliness and promptness of its response. In Dr Jain's e-mail which was sent to me in 2007, before the introduction of the Pre-publishing system, he had stated that he had received my submission and that he would get back to me within seven days and he did!
Most of the manuscripts are published within 3 to 4 months of their submission if they are found to be suitable after the review process. JCDR is published bimonthly and the accepted articles were usually published in the next issue. Recently, due to the increased volume of the submissions, the review process has become slower and it ?? Section can take from 4 to 6 months for the articles to be reviewed. The journal has an extensive author support system and it has recently introduced a paid expedited review process. The journal also mentions the average time for processing the manuscript under different submission systems - regular submission and expedited review.
Strengths of the journal: The journal has an online first facility in which the accepted manuscripts may be published on the website before being included in a regular issue of the journal. This cuts down the time between their acceptance and the publication. The journal is indexed in many databases, though not in PubMed. The editorial board should now take steps to index the journal in PubMed. The journal has a system of notifying readers through e-mail when a new issue is released. Also, the articles are available in both the HTML and the PDF formats. I especially like the new and colorful page format of the journal. Also, the access statistics of the articles are available. The prepublication and the manuscript tracking system are also helpful for the authors.
Areas for improvement: In certain cases, I felt that the peer review process of the manuscripts was not up to international standards and that it should be strengthened. Also, the number of manuscripts in an issue is high and it may be difficult for readers to go through all of them. The journal can consider tightening of the peer review process and increasing the quality standards for the acceptance of the manuscripts. I faced occasional problems with the online manuscript submission (Pre-publishing) system, which have to be addressed.
Overall, the publishing process with JCDR has been smooth, quick and relatively hassle free and I can recommend other authors to consider the journal as an outlet for their work."



Dr. P. Ravi Shankar
KIST Medical College, P.O. Box 14142, Kathmandu, Nepal.
E-mail: ravi.dr.shankar@gmail.com
On April 2011
Anuradha

Dear team JCDR, I would like to thank you for the very professional and polite service provided by everyone at JCDR. While i have been in the field of writing and editing for sometime, this has been my first attempt in publishing a scientific paper.Thank you for hand-holding me through the process.


Dr. Anuradha
E-mail: anuradha2nittur@gmail.com
On Jan 2020

Important Notice

Original article / research
Year : 2024 | Month : November | Volume : 18 | Issue : 11 | Page : ZC07 - ZC11 Full Version

Effect of Sealing Gel on Bacterial Microleakage at Implant-abutment Junction: A Split-mouth Randomised Controlled Trial


Published: November 1, 2024 | DOI: https://doi.org/10.7860/JCDR/2024/73126.20228
Lavesh Manoj Chopra, Umesh Palekar, Deepak Vikhe, Veena Saraf, Rupal Sarode, Vaibhav Nandkumar Awinashe, Minal Awinashe

1. Postgraduate Student, Department of Prosthodontics, Rural Dental College, PIMS DU, Loni, Maharashtra, India. 2. Professor and Head, Department of Prosthodontics, Rural Dental College, PIMS DU, Loni, Maharashtra, India. 3. Associate Professor, Department of Prosthodontics, Rural Dental College, PIMS DU, Loni, Maharashtra, India. 4. Professor, Department of Prosthodontics, Rural Dental College, PIMS DU, Loni, Maharashtra, India. 5. Postgraduate Student, Department of Prosthodontics, Rural Dental College, PIMS DU, Loni, Maharashtra, India. 6. Associate Professor, Department of Prosthodontics, Qassim University, Buraydah, ALQassim, Saudi Arabia. 7. Assistant Professor, Department of Oral Surgery Diagnostic Science, Qassim University, Buraydah, ALQassim, Saudi Arabia.

Correspondence Address :
Dr. Lavesh Manoj Chopra,
Postgraduate Student, Department of Prosthodontics, Pravara Institute of Medical Sciences, Rural Dental College, Loni-413736, Maharashtra , India.
E-mail: laveshmanojchopra@gmail.com

Abstract

Introduction: Dental implants are widely used for tooth replacement; however, challenges such as bacterial microleakage at the Implant-abutment Interface (IAI) can lead to complications. Sealing gels have been developed to close this gap and prevent issues like screw loosening and bacterial infiltration, thereby improving implant success.

Aim: To compare bacterial microleakage at the Implant-abutment Junction (IAJ) with and without the use of sealing gel (conventional method).

Materials and Methods: This Split-mouth randomised controlled study included 30 implant patients who visited the Department of Prosthodontics and the Department of Microbiology at Rural Dental College and Rural Medical College, Pravara Institute of Medical Sciences (Deemed to be University), Ahmednagar, Maharashtra, India, from April 2023 to October 2023. Based on inclusion and exclusion criteria, randomisation was performed using a lottery method, assigning 15 implant samples to each group. Before collecting saline samples, a sterile field assessment was conducted. The sealing gel was injected into the internal compartment of the implant, and a healing abutment was placed in Group A (medical-grade silicone was used as the sealing gel). In Group B, the healing abutment was placed without sealing gel at the IAI. The healing abutment was removed after 15-20 days, and 10 μL of sterile saline was introduced into the internal compartment of the implant using an insulin syringe. The saline was then drawn back up and transferred to the laboratory for microbial assessment to calculate the colony types and the number of colony counts using Colony-forming Units (CFUs). Statistical analysis was performed using the Chi-square test and the Mann-Whitney’s U test.

Results: The mean age of the implant patients was 35±1 years, ranging from 20 to 50 years. Bacterial microleakage assessment showed that Group A (with sealing gel) had 100% sterility, while Group B (without sealing gel) exhibited only 4 (26.67%) sterile samples, 7 (46.66%) with Enterococcus growth, and 4 (26.67%) with Gram-positive bacilli growth in terms of colony types. The sterility in the number of colonies corresponded with the types of colonies for both groups. In Group B, there were 250 colonies in 3 (20%) of the samples, 500 colonies in another 3 (20%), and over 1000 colonies in 2 (13.33%) of the samples. There was a statistically significant difference in the number of sterile samples between the groups (p<0.05). However, intragroup analysis in Group B indicated that the difference in the proportion of the number of colonies was not statistically significant (p>0.05).

Conclusion: The use of sealing gel significantly reduces bacterial microleakage at the IAI, thus improving biomechanics and extending implant longevity for better oral health outcomes.

Keywords

Bacteria flora, Dental implants, Implant-abutment interface, Silicone gel

Dental implants have established themselves as a conventional therapy for replacing missing teeth and facilitating oral restoration in patients with partial or complete edentulism. Although implant-supported restorations have high success rates, they are still prone to complications, failures, and certain limitations (1).

Common complications in implant dentistry include peri-implant mucositis, peri-implantitis, and screw loosening, which typically result in inflammation of the peri-implant tissues and, ultimately, the loss of supporting crestal bone. Bacterial microleakage at the IAI has been identified as one of the primary causes of peri-implantitis. The IAI may significantly contribute to crestal bone loss due to the micro gap between the implant and the abutment in two-piece implant systems (2).

Intraoral bacteria and fluid can ingress into the inner implant space through the IAI micro gap, creating a favourable environment for toxins. The discharge of these substances back through the IAI and the subsequent activation of the adjacent bone tissue may result in alveolar bone loss and peri-implantitis, ultimately culminating in implant failure (3).

The screw is crucial to the implant/abutment assembly, playing a key role in the mechanical performance of screw-retained restorations. The attachment of the implant/abutment assembly relies on the mechanical force generated by the retaining screw, which depends on the rotational force (i.e., torque) applied to it (4). Screw-retained implant-supported prostheses often face biomechanical issues, including screw loosening, which is particularly prevalent in single restorations (1). This leads to instability of the prosthetic component (4).

To reduce IAI bacterial microleakage and screw loosening, sealing gel has been used to close the IAI micro gap, along with anti-loosening agents (3),(5),(6). Sealing gel consists of a silicone matrix, a highly viscous, hydrophobic material that maintains its consistency and provides a hermetic seal without hardening (3). While previous studies have focused on the influence of mechanical factors, such as the implant-abutment fit, on microleakage, research on chemical or gel-based sealing methods has been relatively limited (1),(7),(8). Although in-vitro studies have examined the microleakage and mechanical properties of sealing gel, in-vivo effects have yet to be fully explored (2),(3),(7). Consequently, the present study investigated the bacterial microleakage of sealing gel in the oral environment. The aim of the current study was to compare the bacterial microleakage at the implant-abutment junction with and without sealing gel (conventional method).

Material and Methods

The Split-mouth randomised controlled trial was conducted at the Department of Prosthodontics and the Department of Microbiology at Rural Dental College and Rural Medical College, Pravara Institute of Medical Sciences (Deemed to be University), Ahmednagar, Maharashtra, India, from April 2023 to October 2023. The study protocol received approval from the Institutional Ethical Committee at Pravara Institute of Medical Sciences, with the ethical clearance number DR/IEC, PIMS-DU/2023/241. The study was registered in the Clinical Trial Registry India (CTRI) with the number CTRI/2023/08/056992.

Patients were informed about the nature of the study, and willing participants were asked to sign the informed consent form before the study commenced.

Inclusion criteria: Patients requiring or indicating the need for implant-supported prostheses, as well as those who had previously received two or more dental implants, were included in the study. Patients who had undergone first-stage implant placement were also included, as the sealing gel was applied during the second stage of the procedure. In patients with two or more implants, one implant was treated with the sealing gel, while the other served as a control without the gel, allowing for a comparison within the same patient. The study utilised standardised Dentium Superline R dental implants, which feature a hexagonal internal channel.

Exclusion criteria: Patients with poor oral hygiene and those with parafunctional habits were excluded from the study.

Sample size calculation: A sample size of 30 was calculated using the formula:

n= 2 S2 (Z1-Z2)2/(M1-M2)2

where,

M1 (Mean test intervention): 17.71

This indicates the average value or outcome for the group of implants where the sealing gel (test intervention) was applied.

M2 (Mean control intervention): 24.00

This represents the average value for the group of implants where no sealing gel (control intervention) was applied.

S1 (Standard deviation of M1): 3.73
S2 (Standard deviation of M2): 3.26
Z1 (associated with alpha, typically 1.64485 for a one-sided test)
Z2 (associated with beta, typically 0.84162 for a power of 0.8)

The minimum sample size was 30, with 15 participants in each group (3). This was calculated using the AP Kulkarni software.

Study Procedure

A total of 30 implant samples were included in the study based on the established inclusion and exclusion criteria, with participants’ ages ranging from 20 to 50 years. The sample consisted of nine males and six females. The samples were divided into two groups (A and B), with 15 implant samples in each group. In Group A, Technovent medical-grade silicone was used as a sealing gel between the implants, while in Group B, no sealing gel was placed between the implants (Table/Fig 1).

For the randomisation of patients undergoing implant treatment, each eligible patient who opted for the treatment participated in a random lottery method. Patients were asked to draw a lottery chit from four options: RS (Right-side with sealing gel), RW (Right-side without sealing gel), LS (Left-side with sealing gel), and LW (Left-side without sealing gel). This approach ensured unbiased assignment of patients to different treatment groups, facilitating a fair comparison of outcomes across the RS, RW, LS, and LW options.

Outcome measures: Bacterial microleakage, with and without sealing gel, was assessed by counting CFUs. This assessment was conducted 15 to 20 days after the placement of the sealing gel in Group A, while Group B did not receive any sealing gel.

Second stage surgery/implant level impression and sterile field assessment: The implant site was isolated using sterile cotton rolls and suction. During the second stage of surgery, when taking the implant-level impression, the internal channel of the implant was sterilised with a chlorhexidine solution for 30 seconds to two minutes in both groups A and B (Table/Fig 2)a-c.

The sterile environment was assessed by introducing 10 μl of sterile saline into the internal cavity of the implant using an insulin syringe. It was determined prior to the initiation of the study that the internal volume of the implants could accommodate a saline volume of 10 μl. The saline was then immediately drawn back into the syringe for microbial assessment by culturing the saline sample to evaluate the sterile field. A new sterile insulin syringe was used for each sample (Table/Fig 3)a,b (9).

After the saline sample was drawn back from both groups, sealing gel (Technovent medical-grade silicone) was injected into the internal compartment of Group A, followed by the placement of a healing abutment. In Group B, a healing abutment was placed without injecting sealing gel (conventional method) (Table/Fig 4)a-c.

Saline samples from groups A and B were cultured on Blood Agar (BA) and incubated at 37°C under aerobic conditions for 24 hours to assess sterility. Samples that showed no growth on the BA were included for further bacterial microleakage assessment after the sealing gel was injected, while samples that exhibited growth were excluded from the bacterial microleakage assessment due to contamination from improper sterilisation (Table/Fig 5).

Bacterial microleakage assessment: The healing abutment was removed after full soft tissue healing, which occurred within 15 to 20 days. Subsequently, a sterile insulin syringe was used to introduce sterile saline into the internal compartment of the implant. The saline was promptly withdrawn and transferred into a sterile Brain Heart Infusion (BHI) Broth, which served as an enriched medium for microorganism culturing. Following a 24-hour incubation period, samples were cultured on BA plates and incubated at 37°C under aerobic conditions for an additional 24 hours (Table/Fig 6)a-e.

This procedure was undertaken to evaluate bacterial microleakage at the IAI in both groups A and B. The microbial assessment was meticulously performed, determining the type of colony and the colony count using Colony Forming Units (CFUs).

Statistical Analysis

Data entry was performed using Microsoft Excel spreadsheets, and descriptive and inferential statistical analyses were conducted using SYSTAT version 12 (developed by Crane’s Software, Bengaluru, a licensed copy). Statistical analysis was carried out using descriptive statistics as percentage proportions. All assessment variables under study were compared using Chi-square and Mann-Whitney’s U tests.

Results

The randomised controlled trial included 30 implant patients with a mean age of 35±1 years, ranging from 20 to 50 years. The gender distribution was nine males and six females. A bacterial microleakage assessment of 30 samples was performed for Group A (n=15) (with sealing gel) and Group B (n=15) (without sealing gel) after 15 days of healing abutment placement. The type and number of colonies for both groups were assessed using the CFUs method, and the values were recorded, tabulated, and compared. In Group A, none of the samples showed growth of any bacterial colonies; however, in Group B, 11 samples exhibited growth of bacterial colonies (Table/Fig 7).

Two groups were compared regarding bacterial microleakage at the implant healing abutment junction. Group A, which utilised a sealing gel, demonstrated 100% sterility, indicating the absence of any colony formation. In contrast, Group B, which followed the conventional method without a sealing gel, exhibited only 4 (26.67%) samples that were sterile. Additionally, 7 (46.67%) samples showed growth of enterococcus, and 4 (26.67%) samples showed growth of gram-positive bacilli. The Mann-Whitney’s U test indicated a significant difference (p=0.001) between the two groups, highlighting the superior efficacy of the sealing gel in reducing bacterial microleakage compared to the conventional method that does not use a sealing gel (Table/Fig 8).

A significant variation in the number of colonies was detected between the groups (p=0.001). However, the intragroup analysis in Group B indicated that the difference in the proportion of the number of colonies was not statistically significant (p=0.955) (Table/Fig 9).

Discussion

The use of dental implants to restore partially and fully edentulous arches has become a common and vital approach for enhancing patients’ overall well-being. The effectiveness of these implant restorations depends significantly on both biological and mechanical factors (10),(11),(12). Oral implants are usually implemented in a two-stage process: first, the fixture is surgically inserted, and then, after osseointegration, the transmucosal abutment is attached to the fixture (10),(13),(14).

The internal hexagonal connection, where a segment of the abutment fits into the implant body, is currently the most widely used configuration in two-piece implant systems (15). Forces applied to the prosthetic components can impact the micro-movements or bending of IACs, leading to an increase in the microgap and causing a “pump effect” between the implant and the surrounding peri-implant tissues. Microbial colonisation usually impacts the peri-implant sulci, the external surfaces of implants, and the internal cavities of two-phase dental implants, all of which are vulnerable to bacterial contamination (16). The subgingival gap within the implant components serves as an optimal site for plaque retention. This gap ranges from 1 to 49 mm, providing ample space for microbial leakage (17).

Complications associated with the microgap at the IAI can be either biological issues such as peri-implantitis, peri-implant mucositis, crestal bone resorption, and halitosis; or mechanical problems like abutment/implant fracture or abutment screw loosening. Bacteria can invade and establish themselves in the gaps within the IAI, releasing harmful substances and byproducts into the surrounding tissues. Microleakage may allow the entry of fluids, microorganisms, molecules, and ions into the IAI, potentially leading to biological and mechanical complications, including screw loosening (18).

Literature has confirmed that microbial flora within the implant cavity can arise from contamination during implant placement or from microorganisms introduced from the oral environment after prosthesis insertion. Anti-infective treatment approaches are beneficial for preventing peri-implantitis (17). Suggested treatment methods for addressing contaminated internal implant interfaces include mechanical, chemical, and physical techniques. However, the current scientific literature does not provide enough evidence to support a specific treatment protocol (17).

Various methods have been proposed to reduce or prevent bacterial contamination at the IAI. These include using sealant materials, cleaning the internal cavity of the implant, and employing shape memory alloys. The idea of platform switching, introduced by Lazzara RJ and Porter SS, suggests that a slimmer abutment can increase the distance between the implant-abutment junction and the crestal bone. This adjustment aims to establish an appropriate biological width that minimises microbial contamination and bone loss (19). A range of materials has been suggested for sealing IAIs, such as adhesives, silicone O-rings, silicone sealing washers, chlorhexidine-thymol varnish, and a 2% chlorhexidine solution (20).

Silicone matrix is a highly viscous material that forms a hermetic seal and exhibits hydrophobic characteristics, allowing it to maintain its consistency without hardening. This property is crucial as it prevents microleakage and bacterial colonisation around the implant site, reducing the risk of peri-implant diseases and minimising the potential for complications such as loss of crestal bone. The use of a silicone matrix contributes to additional screw stability, mitigating occlusal stress and preventing abutment screw loosening (1). Its hydrophobic nature also discourages the development of putrid odours, ensuring a more hygienic and comfortable environment for the patient (21).

The present study found a significant difference in bacterial microleakage between implants with and without sealing gel. Group A (with sealing gel) was 100% sterile, while Group B (without sealing gel) showed 26.67% sterility, 46.66% growth of enterococcus, and 26.67% growth of gram-positive bacilli (p=0.001), emphasising the effectiveness of the sealing gel in preventing bacterial microleakage compared to the conventional method without sealing gel.

The effect of the sealing gel varied between the two groups, decreasing IAI microleakage only for implants in which sealing gel was injected. This indicates that the sealing gel is particularly beneficial for designs with poorer sealing properties. The application of sealing gel plays a crucial role in minimising the occurrence of gaps and microleakage at the IAI. The viscous nature of the sealing material facilitates a tight and hermetic seal. A greater volume of sealing gel in the implant’s IAI microgap might explain the reduction in microleakage (3),(21). Yu P et al., and Smojver I et al., suggested that using sealing gel could enhance the longevity of the implant. In contrast, without sealing materials, the potential for leakage significantly increases due to incomplete adaptation and microgaps in the implant-abutment components (3),(21).

A study conducted by Nayak AG et al., and Zarbaksh A et al., proposed the replacement of GapSeal every five years. This recommendation stems from the observation that as GapSeal degrades, its ions are released into the peri-implant tissues. Consequently, assessing the longevity of the material’s effectiveness becomes crucial. Moreover, the influence of oral fluids on the outcomes warrants examination. Parameters such as microbial leakage and fatigue testing might exert diverse effects on the interface (2),(7).

Yu P et al., highlighted that the utilisation of silicone gel could enhance both the immediate securing and long-term resistance to loosening of three implant screw thread connections. This intervention also led to a decrease in IAI microleakage within the Straumann system and a reduction in abutment screw thread wear in the Nobel and Wego systems. No exacerbation in IAI microleakage or thread abrasion was observed in other implant systems. The tested silicone sealing gel demonstrates potential in mitigating the risk of biomechanical complications associated with implant restorations and may prolong their lifespan (3).

The internal surface of the implant can serve as a habitat for bacterial colonisation, potentially causing tissue damage and peri-implant tissue infections. To mitigate the ingress of microorganisms into these regions, Duarte AR et al., advocated for the application of silicone sealant and chlorhexidine varnish in the cervical areas of dental implants. This method remained effective for more than 35 days and demonstrated prolonged prevention of microleakage. Therefore, silicone sealant and chlorhexidine varnish could complement the placement of sealing gel at the IAI (20).

Groenendijk E et al., found that using a 0.2% Chlorhexidine (CHX) solution during second-stage surgery suppressed bacterial growth on the fixtures, with this positive effect lasting upto six weeks. Additionally, CHX gel demonstrated a more prolonged antimicrobial effect in the subgingival environment than CHX solution (22).

The study demonstrated that sealing gel significantly reduced microleakage at the IAI, especially in designs with inherently poorer sealing properties. The application of sealing gel could enhance the longevity of implants by improving their sealing effectiveness. Conducting similar clinical studies to evaluate the duration of the seal provided by sealing gel and its combination with an antimicrobial agent can yield valuable insights into implant maintenance and longevity.

Limitation(s)

The use of final prosthesis abutments would allow for a more comprehensive analysis of the sealing effect, which was not conducted in present study. Additionally, incorporating an antimicrobial agent into the sealing gel could provide added benefits.

Conclusion

Sealing gel effectively reduces bacterial microleakage at the IAI. It decreases microleakage and can contribute to the longevity of implants, thereby benefiting patients’ long-term oral health outcomes. The application of sealing gel plays a crucial role in maintaining a tight seal, preventing microbi

References

1.
Coelho L, Mendes JM, Mendes J, Aroso C, Silva AS, Manzanares-Céspedes MC. Preload and Removal Torque of Two Different Prosthetic Screw Coatings-A Laboratory Study. Materials (Basel). 2024 Mar 20;17(6):1414. Doi: 10.3390/ ma17061414. [crossref][PubMed]
2.
Zarbakhsh A, Mazaheri Tehrani A, Shamshirgar F, Khosroshahi H. Effect of GapSeal® as a sealing material on microgap and microleakage at external hexagon implant connections following cyclic loading: an in-vitro study. Journal of Research in Dental and Maxillofacial Sciences. 2018;3(3):42-48. [crossref]
3.
Yu P, Zhi Li, Tan X, Yu H. Effect of sealing gel on the microleakage resistance and mechanical behavior during dynamic loading of 3 implant systems. J Prosthet Dent. 2022;127(2):308-17. Doi: 10.1016/j.prosdent.2020.05.030. [crossref][PubMed]
4.
Seloto CB, Strazzi Sahyon HB, Dos Santos PH, Delben JA, Assunção WG. Efficacy of sealing agents on preload maintenance of screw-retained implant-supported prostheses. Int J Oral Maxillofac Implants. 2018;33(1):123-26. Doi: 10.11607/jomi.5576. [crossref][PubMed]
5.
Basilio MA, Abi-Rached FO, Butignon LE, Arioli Filho JN. Influence of liquid lubrication on the screw-joint stability of Y-TZP implant abutment systems. J Prosthodont. 2017;26:656-58. [crossref][PubMed]
6.
Asanuma Hirayama PM, Oliveira Lima Bohner L, Marotti J, Steagall W Jr, Laganá DC, Tortamano P. Influence of abutment surface treatments on screw loosening of morse taper implants. Implant Dent 2017;26:718-22. [crossref][PubMed]
7.
Nayak AG, Fernandes A, Kulkarni R, Ajantha GS, Lekha K, Nadiger R. Efficacy of antibacterial sealing gel and O-ring to prevent microleakage at the implant abutment interface: an in-vitro study. J Oral Implantol. 2014;40(1):11-14. Doi: 10.1563/AAID-JOI-D-10-00167. [crossref][PubMed]
8.
Mehl CJ, Steiner M, Ludwig K, Kern M. Wear, microleakage and plastic deformation of an implant-supported chair-side bar system. J Adv Prosthodont. 2015;7:323-28. [crossref][PubMed]
9.
Mawhinney J, Connolly E, Claffey N, Moran G, Polyzois I. An in-vivo comparison of internal bacterial colonization in two dental implant systems: identification of a pathogenic reservoir. Acta Odontol Scand. 2015;73(3):188-94. [crossref][PubMed]
10.
Aishwarya K. Comparative evaluation of the sealing ability of two different sealing agents on the microgap at the implant–abutment interface following cyclic loading: an invitro study (Doctoral dissertation, Ragas Dental College and Hospital, Chennai). 2020. [Updated: 21/02/2021]. Available from: https:// core.ac.uk/works/107369862/?source=1&algorithmId=15&similarToDoc=7 0965313&similarToDocKey=CORE&recSetID=0602fb9e-44f4-45c6-8a11- c99d139e2a11&position=3&recommendation_type=same_repo&otherRecs=70 962897%2C68412799%2C107369862%2C70970185%2C122509197.
11.
Fernández M, Delgado L, Molmeneu M, García D, Rodríguez D. Analysis of the misfit of dental implant-supported prostheses made with three manufacturing processes. J Prosthet Dent. 2014;111(2):116-23. Doi: 10.1016/j. prosdent.2013.09.006. [crossref][PubMed]
12.
Gehrke SA, Shibli JA, Aramburú Junior JS, de Val JE, Calvo-Girardo JL, Dedavid BA. Effects of different torque levels on the implant-abutment interface in a conical internal connection. Braz Oral Res. 2016;30:S1806-233. Doi: 10.1590/1807- 3107BOR-2016.vol30.0040. [crossref][PubMed]
13.
Lorenzoni FC, Coelho PG, Bonfante G, Carvalho RM, Silva NR, Suzuki M, et al. Sealing capability and SEM observation of the implant-abutment interface. Int J Dent. 2011;2011:864183. Doi: 10.1155/2011/864183. [crossref][PubMed]
14.
Berberi A, Tehini G, Rifai K, Bou Nasser Eddine F, Badran B, Akl H. Leakage evaluation of original and compatible implant-abutment connections: In-vitro study using Rhodamine B. J Dent Biomech. 2014;5:1758736014547143. Doi: 10.1177/1758736014547143. [crossref][PubMed]
15.
Lauritano D, Moreo G, Lucchese A, Viganoni C, Limongelli L, Carinci F. The impact of implant-abutment connection on clinical outcomes and microbial colonization: A narrative review. Materials (Basel). 2020;13(5):1131. Doi: 10.3390/ ma13051131. [crossref][PubMed]
16.
Lakha T, Kheur M, Kheur S, Sandhu R. Bacterial colonization at implant-abutment interface: a systematic review. J Dent Specialities. 2015;3(2):176-79. [crossref]
17.
Paolantonio M, Perinetti G, D’Ercole S, Graziani F, Catamo G, Sammartino G, et al. Internal decontamination of dental implants: an in-vivo randomized microbiologic 6-month trial on the effects of a chlorhexidine gel. J Periodontol. 2008;79(8):1419-25. Doi: 10.1902/jop.2008.070660. [crossref][PubMed]
18.
Mishra SK, Chowdhary R, Kumari S. Microleakage at the different implant abutment interface: a systematic review. J Clin Diagn Res. 2017;11(6):ZE10- ZE15. Doi: 10.7860/JCDR/2017/28951.10054. [crossref][PubMed]
19.
Lazzara RJ, Porter SS. Platform switching: a new concept in implant dentistry for controlling postrestorative crestal bone levels. Int J Periodontics Restorative Dent. 2006;26(1):09-17. PMID: 16515092.
20.
Duarte AR, Rossetti PH, Rossetti LM, Torres SA, Bonachela WC. In-vitro sealing ability of two materials at five different implant-abutment surfaces. J Periodontol. 2006;77(11):1828-32. Doi: 10.1902/jop.2006.060101. [crossref][PubMed]
21.
Smojver I, Bjelica R, Vuletić M, Gerbl D, Budimir A, Gabric´ D. Antimicrobial efficacy and permeability of various sealing materials in two different types of implant-abutment connections. Int J Mol Sci. 2022;23(14):8031. Doi: 10.3390/ ijms23148031. [crossref][PubMed]
22.
Groenendijk E, Dominicus JJ, Moorer WR, Aartman IH, van Waas MA. Microbiological and clinical effects of chlorhexidine enclosed in fixtures of 3I-Titamed implants. Clin Oral Implants Res. 2004;15(2):174-79. Doi: 10.1111/ j.1600-0501.2004.00977.x.[crossref][PubMed]

DOI and Others

DOI: 10.7860/JCDR/2024/73126.20228

Date of Submission: May 29, 2024
Date of Peer Review: Jul 08, 2024
Date of Acceptance: Sep 19, 2024
Date of Publishing: Nov 01, 2024

AUTHOR DECLARATION:
• Financial or Other Competing Interests: None
• Was Ethics Committee Approval obtained for this study? Yes
• Was informed consent obtained from the subjects involved in the study? Yes
• For any images presented appropriate consent has been obtained from the subjects. Yes

PLAGIARISM CHECKING METHODS:
• Plagiarism X-checker: May 30, 2024
• Manual Googling: Jul 12, 2024
• iThenticate Software: Sep 18, 2024 (10%)

ETYMOLOGY: Author Origin

EMENDATIONS: 9

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