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

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Dr Mohan Z Mani

"Thank you very much for having published my article in record time.I would like to compliment you and your entire staff for your promptness, courtesy, and willingness to be customer friendly, which is quite unusual.I was given your reference by a colleague in pathology,and was able to directly phone your editorial office for clarifications.I would particularly like to thank the publication managers and the Assistant Editor who were following up my article. I would also like to thank you for adjusting the money I paid initially into payment for my modified article,and refunding the balance.
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Dr Mohan Z Mani,
Professor & Head,
Department of Dermatolgy,
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.
As an experienced dentist and an academician, I proudly recommend this journal to the dental fraternity as a good quality open access platform for rapid communication of their cutting-edge research progress and discovery.
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

Research Protocol
Year : 2024 | Month : November | Volume : 18 | Issue : 11 | Page : ZK01 - ZK03 Full Version

Efficacy of Novel PRP Loop versus Opus Loop for Anterior En-Masse Retraction in Angle’s Class I Dewey’s Type 2 Malocclusion: A Randomised Clinical Trial Protocol


Published: November 1, 2024 | DOI: https://doi.org/10.7860/JCDR/2024/72876.20227
Krushnali N Kolhatkar, Priyanka Niranjane, Pallavi Daigavane, Kushal Taori

1. Junior Resident, Department of Orthodontics and Dentofacial Orthopedics, Sharad Pawar Dental College and Hospital, Datta Meghe Institute of Higher Education and Research, Wardha, Maharashtra, India. 2. Associate Professor, Department of Orthodontics and Dentofacial Orthopedics, Sharad Pawar Dental College and Hospital, Datta Meghe Institute of Higher Education and Research, Wardha, Maharashtra, India. 3. Professor, Department of Orthodontics and Dentofacial Orthopedics, Sharad Pawar Dental College and Hospital, Datta Meghe Institute of Higher Education and Research, Wardha, Maharashtra, India. 4. Junior Resident, Department of Orthodontics and Dentofacial Orthopedics, Sharad Pawar Dental College and Hospital, Datta Meghe Institute of Higher Education and Research, Wardha, Maharashtra, India.

Correspondence Address :
Dr. Krushnali N Kolhatkar,
Department of Orthodontics and Dentofacial Orthopedics, Sharad Pawar Dental College and Hospital, Datta Meghe Institute of Higher Education and Research, Sawangi, Wardha-442001, Maharashtra, India.
E-mail: drkrushnalimds@gmail.com

Abstract

Introduction: Optimal space closure is a pivotal aspect of orthodontic treatment, particularly challenging in patients with bimaxillary protrusions and Angle’s class II division 1 malocclusion. Two primary methods, friction, and frictionless mechanisms, are employed for anterior teeth retraction. However, concerns over prolonged treatment duration and increased anchorage demands have prompted exploration into non-frictional approaches. Biomechanical properties significantly influence the efficacy of retraction loops, with ideal loops exhibiting high Moment-to-Force (M/F) ratios and low Force-to-Deflection (F/D) ratios. The “PRP loop” was developed inspired by existing designs, showing promising biomechanical characteristics in a finite element study. However, its clinical efficacy remains unexplored.

Need of the study: More research is required to assess the clinical efficacy of the recently created PRP loop in promoting retraction. This trial attempts to evaluate the effectiveness of the PRP loop compared to current techniques, focusing on attaining effective anterior en-masse retraction. Through an analysis of the benefits and limitations of both methods, the research aims to shed light on which loop provides the best space closure.

Aim: This study aims to evaluate and compare the PRP loop with the Opus loop for anterior en-masse retraction in Angle’s class I Dewey’s Type 2 malocclusion.

Materials and Methods: A prospective single-blinded randomised clinical trial will be conducted in the Department of Orthodontics and Dentofacial Orthopedics at Sharad Pawar Dental College and Hospital, Sawangi, Wardha, Maharastra from September 2024 to April 2026. Thirty patients between the age of 15-30 years having Angle’s Class I Dewey’s type 2 malocclusion requiring maxillary premolar extraction will be included and divided into two groups (PRP and Opus loop groups) with the exclusion of Angle’s Class II and III cases. Treatment procedures include initial alignment, maxillary premolar extractions, and retraction using respective loops. Evaluation criteria encompass retraction rate, efficacy, and anchorage loss measured through study models and radiographic assessments. Statistical analysis will employ Student’s paired and unpaired t-test and Chi-square test with GraphPad Prism 7.0 and SPSS 27.0 software and a significance level of p<0.05.

Keywords

Anchorage loss, Frictionless mechanism, Retraction loops

Achieving optimal space closure remains a complex challenge in orthodontic treatment, particularly for Subjects with prominent bimaxillary protrusions and Angle’s class II division 1 malocclusion. This challenge involves retracting anterior teeth, with two primary approaches: friction and frictionless mechanism (1). Effectively closing the extraction spaces is critical for the success of orthodontic outcomes. Anterior en-masse retraction can be performed using various methods. One of the most commonly used sliding mechanics has concerns regarding prolongation of treatment time and increased anchorage demands and hence has fuelled the investigation of alternative, non-frictional approaches. Irrespective of the anchorage technique, the en masse retraction tends to cause decreased mesial shifts of the anchors (2).

A diversiform lineup of loop designs exists, including opus, K SIR, mushroom, vertical, T, L, teardrop, omega, and others. The efficacy of any retraction loop in facilitating space closure is particularly dependent on its biomechanical characteristics (3). Among these, superlative retraction loops are characterised by a high ratio of M/F approaching 10:1 in addition to a low rate of F/D (4). These parameters straightaway influence the loop’s efficaciousness in generating controlled tooth movement. Therefore, meticulous computation of both the ratio of M/F and F/D rate before deploying any retraction loop for extraction space closure is pivotal for ensuring foreseeable and effective treatment results.

Inspired by the L loop and Opus loop designs, Dr. Pallavi Daigavane of the Sharad Pawar Dental College developed the “PRP loop” (4),(5). A consequential finite element study by Kumari S et al., compared the PRP loop’s biomechanical characteristics to those of the Opus and L loops. Their findings revealed that the PRP loop boasts a considerably higher M/F ratio, potentially making it an efficient tool for tooth retraction (4). Furthermore, Siatkowski’s (1997) Opus loop was created with the innate capacity to provide a desired M/F of 8.0-9.1 mm, avoiding residual moments through bends or twists (also called gable bends) at any point before insertion into the archwire and loop. Hence, these combined benefits are advantageous options for various orthodontic applications (6).

To best of our knowledge, no study has been conducted to assess the clinical efficacy of the new PRP loop. This clinical trial will help determine PRP and Opus loop’s advantages and disadvantages in retraction. Thus, the present study aims to evaluate and compare the efficacy of the novel PRP loop with the Opus loop for anterior en-masse retraction in Angle’s Class I Dewey’s type 2 malocclusion.

Primary objective: To evaluate and compare the rate of anterior en-masse retraction achieved with PRP and Opus loop.

Secondary objective: To assess and compare the anchorage loss associated with PRP and opus loop during anterior en-masse retraction.

Null hypothesis: PRP and opus loop will be equally effective in anterior en-masse retraction.

Alternate hypothesis: PRP loop is better than opus loop in anterior en-masse retraction.

Review of Literature

The biomechanics of tooth movement for closing extraction spaces are influenced by factors such as the moment/force ratio, the F/D rate, the amount of force generated, and the specific configuration of the loop. These factors combined create a complex biomechanical system that influences the translatory movement of the teeth. Rao PR et al., examined the Snail loop’s biomechanical characteristics with those of the Opus and Teardrop loops in a FEM research and found opus loop exhibited a higher ratio of M/F and the lowest F/D rate in comparison to both snail and teardrop loops (7).

Guroo DK et al., compared open with closed loops for incisor retraction, focusing on speed, tooth movement, and anchorage, and found Open loop has faster incisor retraction (0.023 mm/day vs. 0.0194 mm/day), more inter-canine width reduction and molar rotation and increased nasolabial angle (flatter profile) (8). While closed loop has more controlled incisor retraction with no torque loss and slower retraction and concluded that open loops offered faster retraction but with potential inter-canine narrowing, molar rotation, and profile flattening, while closed loops provided slower but more controlled retraction, minimising unwanted tooth movement.

Alhadlaq A et al., Compared anchorage preservation with transpalatal arches in continuous vs. segmented arch techniques for canine retraction and found significant molar movement forward (4.5 mm) in continuous technique and minimal molar movement (0.2 mm) using a segmented loop (9). They concluded that T-loops with posterior anchorage bend in segmented arches significantly improve anchorage compared to continuous arches during canine retraction.

Rizk M et al., systematically reviewed and analysed the effectiveness of en masse versus two-step retraction by comparing the anchorage preservation and retraction of Upper Incisors (U1) and concluded that both the methods are in space closing phase have been proved effective (2). Also, qualitatively stated that less time is required in the first method when compared to the latter.

Material and Methods

A prospective single-blinded randomised clinical trial will be conducted from September 2024 to April 2026, at the outpatient Department of Orthodontics and Dentofacial Orthopedics at Sharad Pawar Dental College and Hospital, Sawangi, Wardha. All processes related to Subjects will adhere to the 1964 Helsinki Declaration, its later amendments, or comparable ethical norms, in addition to the Institutional Ethics Committee’s guidelines. The proposed research (Ref. No. DMIHER(DU)/IEC/2024/250) has been approved by the Institutional Ethics Committee at its meeting on January 30th, 2024. The registered CTRI number is CTRI/2024/07/070006.

Inclusion criteria:

• Subjects between the ages of 15 to 30 years.
• Subjects with Angle’s Class I Dewey’s type 2 malocclusion.
• Subjects having average growth pattern requiring maxillary premolar extractions.
• Moderate to critical anchorage cases.
• Those with healthy periodontal status, without periodontal pocket depths more than 2 to 3 mm, and the ones who require fixed orthodontic treatment.

Exclusion criteria:

• Angle’s Class II and III malocclusion.
• Subjects having inborn and developmental syndromes.
• Systemic disorders like clotting diseases or conditions such as pregnancy.

The treatment modality will be explained to the subjects and those who agree to participate; informed consent will be obtained with a signature.

Sample size calculation: The incisor exposure in relation to the upper lip from Guroo DK et al., study will be taken into consideration while determining the sample size. Where Mean incisor exposure wrt. upper lip at T0=5.83 (8).

Mean incisor exposure wrt. upper lip at T4=4.45.
For detecting mean difference of 1.38 i.e., ?=5.83-4.45=1.38.
σ1=Standard deviation of incisor exposure wrt upper lip at T0=1.60.
σ2=Standard deviation of incisor exposure wrt upper lip at T4=1.05.
K=1. Two-sided Z value (eg. Z=1.96 for 95% confidence interval)= power.

N= (1.60*1.60+1.05*1.05) (1.96+0.84)2/1.38*1.38

15.07=15 Subjects needed in each group. Total 30 subjects. Power of the test: 80%. Level of Significance: 5% (95% confidence interval).

Procedure

The materials that will be required in this research are lateral cephalograms, study model investigations, and 0.019×0.025-inch Titanium Molybdenum Alloy wires. A total of 30 subjects will be divided into two groups, with 15 in every group: Group-A: Individuals will receive PRP Loop, and Group-B: Individuals will receive opus loop. PRP and Opus loop randomisation will be done in a 1:1 ratio, and concealment of allocations will be assured by employing a web front-end “sealed envelope” by a centralised online randomisation system. Detailed case histories, radiographs, and study models will be methodically assembled. In all the cases, stainless steel brackets will be placed of 0.022×0.028 slot dimension with MBT prescription (McLaughlin, Bennett, Trevisi). The orthodontic treatment will begin with initial leveling and aligning of teeth by sequentially using 0.016 inch round NiTi, 0.016×0.022 inch rectangular NiTi, 0.017×0.025 inch rectangular NiTi, 0.017×0.025 inch rectangular SS, 0.019×0.025 inch rectangular NiTi, 0.019×0.025 inch rectangular SS, 0.019×0.025 inch rectangular TMA wires. Anchorage preparation will be done using a transpalatal arch. After maxillary premolar extractions, pre-intervention lateral cephalograms and study model impressions will be recorded (T0). Anterior en-masse retraction will be performed using a PRP loop and Opus loop fabricated from 0.019×0.025 inch titanium molybdenum alloy wire. Gable bends of 15° α and 25° β will be incorporated into the PRP loop (4). No gable bends are required in the Opus loop (6). A 2 mm activation will be done in both the loops by cinch back, using orthodontic cinch back plier number 10/129. Study model impression will be collected after two months (T2) and post-extraction space closure, while lateral cephalogram will be taken after extraction space closure.

Primary outcomes: The retraction rate will be measured by linear measurement on the study model of extraction space closure using vernier caliper. Anterior en-masse retraction efficacy will be measured by angular measurement on lateral cephalogram from the U1 to SN and linear measurement on lateral cephalogram of incisal exposure concerning upper lip (8).

Secondary outcomes: Anchorage loss will be measured by molar rotation in the transverse plane on the study model (10), Nasal Floor (NF) to upper 1st molar (U6) in the vertical plane, and Pterygoid Vertical (PTV) to the distal surface of upper 1st molar (U6) in the sagittal plane.

Statistical Analysis

The software analysis will be conducted with GraphPad Prism 7.0 and SPSS version 27.0. Statistics will be performed using students’ paired and unpaired t-tests and the Chi-square test with a level of significance of p <0.05.

References

1.
Nandan H, Kumar CS, Jha P. Comparison of maxillary canine retraction using split-mouth design with dual force cuspid retractor and t-loop segmental arch: a split-mouth randomized clinical trial. Cureus. 2023;15:e35288. Doi: 10.7759/ cureus.35288. [crossref]
2.
Rizk MZ, Mohammed H, Ismael O, Bearn DR. Effectiveness of en masse versus two-step retraction: a systematic review and meta-analysis. Prog Orthod. 2018;18:41. 10.1186/s40510-017-0196-7. [crossref][PubMed]
3.
Sud K, Mittal S, Aggarwal I, Palkit T. Loop mechanics-A review. Int Dent J Stud Res. 2022;10:71-76. Doi: 10.18231/j.idjsr.2022.016. [crossref]
4.
Kumari S, Niranjane P. Evaluation and comparison of momentto-force ratio of a new “PRP Loop” with that of opus loop and l loopa finite element method study. J Clin Diagn Res. Published Online First: 2023. Doi: 10.7860/ JCDR/2023/63343.17944. [crossref]
5.
Kumari S, Niranjane P, Kamble R. Evaluation and comparison of biomechanical properties of a new “PRP Loop” with that of opus loop and l-loop - a FEM study. J Pharm Res Int. 2021;33:75-79. Doi: 10.9734/jpri/2021/v33i64A35302. [crossref]
6.
Siatkowski RE. Continuous arch wire closing loop design, optimization, and verification. Part II. Am J Orthod Dentofacial Orthop. 1997;112:487-95. Doi: 10.1016/S0889-5406(97)70075-1. [crossref][PubMed]
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DOI and Others

DOI: 10.7860/JCDR/2024/72876.20227

Date of Submission: May 17, 2024
Date of Peer Review: Jun 18, 2024
Date of Acceptance: Aug 20, 2024
Date of Publishing: Oct 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? No
• For any images presented appropriate consent has been obtained from the subjects. No

PLAGIARISM CHECKING METHODS:
• Plagiarism X-checker: May 22, 2024
• Manual Googling: Jun 20, 2024
• iThenticate Software: Aug 19, 2024 (6%)

ETYMOLOGY: Author Origin

EMENDATIONS: 6

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