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.
I wish all success to your journal and look forward to sending you any suitable similar article in future"



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 : April | Volume : 18 | Issue : 4 | Page : ZK01 - ZK03 Full Version

Effectiveness of Photobiomodulation alone and 0.5% Nanocurcumin Gel with Photobiomodulation in Treating Myogenous Temporomandibular Disorders: Protocol for a Randomised Clinical Trial


Published: April 1, 2024 | DOI: https://doi.org/10.7860/JCDR/2024/67219.19270
Sourabh B Shinde, Vidya K Lohe

1. Postgraduate Student, Department of Oral Medicine and Radiology, Sharad Pawar Dental College and Hospital, DMIHER, Sawangi (Meghe), Wardha, Maharashtra, India. 2. Professor and Guide, Department of Oral Medicine and Radiology, Sharad Pawar Dental College and Hospital, DMIHER, Sawangi (Meghe), Wardha, Maharashtra, India.

Correspondence Address :
Dr. Sourabh B Shinde,
Postgraduate Student, Department of Oral Medicine and Radiology, Sharad Pawar Dental College and Hospital, Sawangi (Meghe), Wardha-442001, Maharashtra, India.
E-mail: sourabhshinde008@gmail.com

Abstract

Introduction: Temporomandibular Disorders (TMD) encompass a variety of clinical dysfunctions affecting the Temporomandibular Joint (TMJ), masticatory muscles, and nearby tissues. Pain typically originates from the muscles associated with the functional movements of these structures. Low-level Laser Therapy (LLLT) has been used in TMD patients to control inflammation and disrupt the stress-pain-stress cycle. Curcuma longa is a significant plant in Asia used for medicinal purposes. Curcumin (diferuloylmethane) is a hydrophobic bioactive compound commonly found in the rhizome of C. longa. Considerable attention has been given in recent years to its various pharmacological actions. The available research has shown significant potential in inflammation control, with nano-range preparations of curcumin (Nanocurcumin) enhancing the pharmacological actions and benefits of curcumin, which were not markedly achievable before.

Need of the study: The TMDs are among the most common types of disorders associated with orofacial pain. Conditions originating from stress related to the joint often impact the associated muscles, initiating the stress-pain-stress cycle. As TMDs do not have a definitive treatment plan, further research is needed regarding the treatment associated with TMDs.

Aim: To assess the effectiveness of photobiomodulation alone and 0.5% nanocurcumin gel with photobiomodulation in treating myogenous TMDs.

Materials and Methods: In the present randomised clinical trial, 44 patients with myogenous TMDs will be included. The patients will be divided into two groups: Group A will receive laser applications at the trigger zones, and Group B will receive the application of 0.5% nanocurcumin gel along with laser at the trigger zones. Patients will be assessed for jaw opening, Beck’s Anxiety Inventory, and Visual Analogue Score after four weeks.

Keywords

Diferuloylmethane, Inflammations, Photobiomodulation therapy

Considered the foremost reason for non dental facial pain, TMDs involve a large variety of mastication muscles and TMJ symptoms with a prevalence of 20-25% among adolescents (1). Multifactorial aetiology, lack of diagnostic parameters, and the inability of patients to locate the pain in the TM Joint regions are the primary causes of delay in diagnosis. The Visual Analogue Scale (VAS) score and mouth-opening analysis are the most used tools for analysis. However, aspects like chronic pain, depression, and anxiety are neglected. Therefore, the Research Diagnosis Criteria for TMD (RDC/TMD) has been developed and used worldwide as the gold standard (1). Myogenous TMDs are the type of TMDs associated with the joint’s muscular component. The muscles attached to the TMJ aid in the opening and closing of the joint. Often, after a stressful event on the muscles, they initiate the stress-pain-stress cycle, leading to pain in the muscular component of the joint (1).

Therapies like Photobiomodulation Medical care (PBM) aim to alleviate TMD symptoms. Treatment of photobiomodulation involves using an optical laser to reduce inflammation, pain, oedema, and regeneration of broken tissues like bones (1),(2). It includes the photo absorption by the natural group cytochrome enzyme catalysing the metabolic oxidation-reduction reaction, increasing metabolism, which ends in the proliferation of cells, inhibitor and redox-regulation, hindrance of necrobiosis, restoration of metabolism of cells, and reducing pain and inflammation (1),(2). Photobiomodulation has been previously used in many studies (1),(2),(3),(4) associated with TMDs and myofascial pain dysfunction syndrome and has shown promising results while using photobiomodulation alone and in combination with diclofenac gel. Thus, photobiomodulation was considered as the treatment modality.

Curcumin (diferuloylmethane) is a hydrophobic bioactive element that is commonly found in the rhizome of C. longa (5),(6). Upon searching various databases, the study material available on using nanocurcumin in treating myogenous TMD was minimal, as only a few studies were performed with the following material (nanocurcumin) in treating osteoarthritis and orofacial pain (7),(8),(9),(10). Most treatments associated with nanocurcumin were performed for pain and inflammation associated with knee joints. Thus, nanocurcumin was considered the material of choice for the present study.

Literature is sparse on the use of combination therapy of photobiomodulation with curcumin in TMDs. Thus, the present study aimed to compare the effectiveness of photobiomodulation and nanocurcumin, alone or combined (0.5%), in treating TMD pain.

Objectives

Assessing the effectiveness of photobiomodulation alone in treating myogenous TMDs. To assess the effectiveness of 0.5% nanocurcumin gel with photobiomodulation in treating myogenous TMDs. To compare the effectiveness of photobiomodulation alone and 0.5% nanocurcumin gel with photobiomodulation in treating myogenous TMDs.

REVIEW OF LITERATURE

Brochado FT et al., conducted a study on the effectiveness of photobiomodulation in the treatment of TMDs (1). The study evaluated parameters involving the intensity of pain, movements of the mandible, aspects of social and psychological factors, and symptoms related to anxiety in TMDs. A total of 51 patients were randomly assigned to three groups: Group 1, with 18 patients receiving laser; Group 2, with 16 patients receiving physiotherapy for 20 minutes for mastication and joint muscles; and Group 3, with 17 patients receiving combination therapy. All groups showed reductions in pain, and jaw movements improved during treatment and at follow-up.

A study evaluating the effects of photobiomodulation on the transdermal absorption of diclofenac in healthy volunteers was conducted by Leonardo PS et al., (2). After assessing their health status, volunteers were selected based on the criteria of 12 with black skin and 12 with white skin, and the study was initiated for the determination of pharmacokinetic parameters. During hospitalisation, the volunteers were given 5 grams of diclofenac in gel form with or without photobiomodulation following randomisation. A fourteen-laser diode cluster delivered energy to each diode. Haematological samples were obtained to determine the plasmatic diclofenac concentration using tandem mass spectrometry at various time points. The effective wavelength of 650 nm enhanced the absorption of diclofenac gel, favouring white-skinned individuals but not those with black skin. The white-skinned volunteers who received low-level lasers before the drug application showed significant improvements compared to those who received a placebo.

A study investigating the penetration and the effects against neoplastic activities of curcumin using liposomes for transdermal delivery was conducted by Chen Y et al., (5). Phospholipids (soybean, egg yolk, and hydrogenated) were used to prepare the liposomes, which were loaded with curcumin. Soybeans promoted drug permeation and deposition most significantly, followed by egg yolk, hydrogenated, and curcumin solution.

Malekzadeh M et al., conducted a study on the effects of nano-curcumin on the gingiva in patients with gingival and periodontal involvement (6). A total of 48 patients were selected. One group received curcumin, and a placebo was given to the other. The assessment was done on the gingiva, papilla, and plaque indices. Both groups showed promising improvements, which were even better in the curcumin group, with no side-effects.

The study conducted by Zhang Z et al., evaluated the use of curcumin in treating osteoarthritic progression and associated pain (7). The evaluation of cartilage degradative-associated genes was performed using real-time Polymerase Chain Reaction (PCR) assessment of curcumin and curcumin nanoparticles in human primary chondrocytes. Mice subjected to Destabilisation of the Medial Meniscus (DMM) surgery were orally and topically administered nanoparticles for eight weeks. Both forms of curcumin suppressed the messenger Ribonucleic Acid (mRNA) expression of proinflammatory mediators Interleukin-1β (IL-1β) and Tumour Necrosis Factor-α (TNF-α), as well as MMPs 1, 3, and 13. Significant improvement was observed in both oral and topical administration, with topical oral administration showing better results than oral.

Material and Methods

The randomised controlled clinical trial will be conducted at the Department of Oral Medicine and Radiology and the Department of Periodontics at Sharad Pawar Dental College, DMIHER, Sawangi, (M) Wardha, Maharashtra, India. The study protocol has been approved by the Institutional Ethics Committee and registered with CTRI NO: REF/2022/06/055852. The study protocol will be explained to the participating patients, and written informed consent will be obtained from them (https://ctri.nic.in/Clinicaltrials/main1.php?EncHid=39494.39456).

Inclusion criteria: Patients with myogenous TMDs will be included. Patients will undergo examination for TMDs based on clinical inspection and palpation of the joint and muscles of mastication.

A study orthopantomogram will be taken to exclude patients with bony aetiologies. Once myogenous aetiologies are confirmed, patients will be considered for the study.

Exclusion criteria: Patients with bony pathologies of the TMJ, a history of facial trauma, congenital developmental anomalies, and malignancies will be excluded from this study.

Sample size calculation: The sample size was calculated using the following formula:

n= x2, N.P(1-P)/c2(N-1)+22.P. (1-P)

Where:
X=Chisanare tabulated value for one degree of freedom at a 95% confidence interval=3.84
P=Proportion of 50%=0.50
N=Total number of patients, i.e., 50
C=Desired margin of error=5%=0.05
n=44.34
n=44

The flow diagram depicting the distribution of study participants has been presented in (Table/Fig 1).

Study Procedure

After informing the patient about the study, consent will be obtained. Following the detailed case history as per the prescribed proforma, all necessary findings such as pain-free jaw opening, Visual Analogue Score (VAS) and Beck’s Anxiety Inventory (BAI) index (1) will be noted. The zones with the maximum discomfort from which the pain originates will be analysed based on the patient’s history and manual palpatory examination (Trigger Zones).

To avoid selection bias, a chit system will be used to select the patient. The chits will be drawn by someone other than the patient or clinician. The clinician will be informed about the group allocation, and the patient will be blinded.

According to the allotted chit, the patient will be assigned to one of the following groups:

1) Group A-LLLT only (GaAlAs diode laser, 800-900 nm. Biolase, Foothill Ranch, CA, USA.)

2) Group B-0.5% nanocurcumin gel (Sigma-Aldrich, St. Louis, Missouri, USA)+LLLT (GaAlAs diode laser, 800-900 nm. Biolase, Foothill Ranch, CA, USA.)

Group A will receive laser application at the trigger zones thrice per week for four weeks, following the specified schedule (GaAlAs diode laser of wavelength 880 nm and 0.8 W power, Time: 4 minutes. Biolase, Foothill Ranch, CA, USA.)

Group B will receive applications of 0.5% nanocurcumin gel (Sigma- Aldrich, St. Louis, Missouri, USA) at the trigger zones thrice per week for four weeks. The application of low-level laser will follow the schedule as specified (GaAlAs diode laser of wavelength 880 nm and 0.8 W power, Time: four minutes. Biolase, Foothill Ranch, CA, USA.)

After four weeks, the patients will be evaluated for pain-free jaw opening, VAS, and BAI. All groups will be examined, and data will be collected for comparison at the end of the study.

Primary outcome: According to the reviewed observations from various studies, the combination therapy will be more effective than the photobiomodulation therapy alone. The expected dose of laser will be reduced significantly and the drug penetration will be improved after encountering laser. It will be more effective in reduction of pain, as well as improving the pain free mouth opening.

Secondary outcome: The number of visits that are required in combination therapy will be lesser as compared with photobiomodiulation therapy alone.

Statistical Analysis

The gathered data will be analysed using Statistical Package for Social Sciences (SPSS) 27.0 Version software. Descriptive and analytical statistical methods will be employed for data analysis. The statistical significance of the mean differences between the pain levels on the VAS, pain-free jaw opening, and BAI will be examined on the same day, the 15th day, and one month later, and will be compared between both groups (i.e., Group A and Group B).

References

1.
Brochado FT, Jesus LH, Carrard VC, Freddo AL, Chaves KD, Martins MD. Comparative effectiveness of photobiomodulation and manual therapy alone or combined in TMD patients: A randomised clinical trial. Braz Oral Res. 2018;32:e50. [crossref][PubMed]
2.
Leonardo PS, de Paiva Carvalho RL, da Silva SG, Mendes GD, de Nucci G, Lopes-Martins RA. Photobiomodulation therapy enhances topical diclofenac absorption in healthy volunteers-a randomised placebo-controlled trial: Preliminary results. Res Soc Dev. 2021;10(12):e265101220448. [crossref]
3.
Gholami L, Asefi S, Hooshyarfard A, Sculean A, Romanos GE, Aoki A, et al. Photobiomodulation in periodontology and implant dentistry: Part 1. Photobiomodul Photomed Laser Surg. 2019;37(12):739-65. Doi: 10.1089/photob.2019.4710. Epub 2019 Nov 21. PMID: 31750783. [crossref][PubMed]
4.
Tang E, Arany P. Photobiomodulation and implants: Implications for dentistry. J Periodontal Implant Sci. 2013;43(6):262-68. [crossref][PubMed]
5.
Chen Y, Wu Q, Zhang Z, Yuan L, Liu X, Zhou L. Preparation of curcumin-loaded liposomes and evaluation of their skin permeation and pharmacodynamics. Molecules. 2012;17(5):5972-87. [crossref][PubMed]
6.
Malekzadeh M, Kia SJ, Mashaei L, Moosavi MS. Oral nano-curcumin on gingival inflammation in patients with gingivitis and mild periodontitis. Clin Exp Dent Res. 2021;7(1):78-84. Doi: 10.1002/cre2.330. Epub 2020 Sep 21. PMID: 32954688; PMCID: PMC7853903. [crossref][PubMed]
7.
Zhang Z, Leong DJ, Xu L, He Z, Wang A, Navati M, et al. Curcumin slows osteoarthritis progression and relieves osteoarthritis-associated pain symptoms in a post-traumatic osteoarthritis mouse model. Arthritis Res Ther. 2016;18(1):128. Doi: 10.1186/s13075-016-1025-y. PMID: 27260322; PMCID: PMC4891896. [crossref][PubMed]
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Tables and Figures
[Table / Fig - 1]
DOI and Others

DOI: 10.7860/JCDR/2024/67219.19270

Date of Submission: Aug 25, 2023
Date of Peer Review: Oct 19, 2023
Date of Acceptance: Dec 30, 2023
Date of Publishing: Apr 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. NA

PLAGIARISM CHECKING METHODS:
• Plagiarism X-checker: Aug 26, 2023
• Manual Googling: Oct 21, 2023
• iThenticate Software: Feb 24, 2024 (8%)

ETYMOLOGY: Author Origin

EMENDATIONS: 8

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