Previously submitted to: JMIR Research Protocols (no longer under consideration since Aug 21, 2025)
Date Submitted: Mar 6, 2025
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
Assessment of Occurrence and Comparison of Temporomandibular Disorders in Individuals with and without Unilateral Complete Cleft Lip and Palate Using Helkimo Index and Radiographic Analysis: A Research Protocol
ABSTRACT
Background:
Cleft lip and palate is one of the most common congenital craniofacial abnormalities. There is a wide correlation between skeletal Class III malocclusion and TMDs in non-cleft patients and also that skeletal Class III Malocclusion is most commonly seen in Cleft Lip and Palate. TMJ morphological variations and TMD occurrence in adults with complete unilateral cleft lip and palate should be taken into consideration.
Objective:
To assess the occurrence and compare the Temporomandibular disorders in individuals with and without unilateral complete Cleft lip and palate using Helkimo Index and Radiographic Analysis.
Methods:
This observational study will involve a total of 20 participants who will be selected based on the outpatient department (OPD) and Smile Train OPD at Sharad Pawar Dental College, Wardha which will further be selected based on inclusion and exclusion criteria opted for the study. The study will be conducted for 1 year 3 months. Informed consent will be undertaken. The patients will be first examined clinically using Helkimo Index and then the MRI scan to assess for Temporomandibular disorders. A comparative analysis will be done for individuals with and without Cleft Lip and Palate. . Statistical analysis will be conducted utilizing descriptive and inferential statistics, specifically employing Student’s paired and unpaired t-tests. A significance level of p<0.05 will be utilized for determining statistical significance.
Results:
Primary outcome: The prevalence and morphological variations of Temporomandibular Disorders (TMDs) in individuals with unilateral complete cleft lip and palate (UCLP) compared to individuals without a cleft (control group) using Helkimo index and radiographic analysis. Secondary outcome: Comparison of specific TMD symptoms, Radiographic analysis of the temporomandibular joint (TMJ), Dental malocclusion, Functional limitations, Quality of life could be anticipated.
Conclusions:
This study's expected outcome on Temporomandibular joints will show morphological variations as individuals with UCLP tend to have TMDs do occur in UCLP patients with the help of radiographic analysis and helkimo index, as the occurrence of TMD’s in patient using helkimo index has higher occurrence. Clinical Trial: CTRI/2024/06/069407 The Institutional Ethical Clearance (IEC) has been obtained prior to the study- DMIHER(DU)/IEC/2024/252.
Citation
Request queued. Please wait while the file is being generated. It may take some time.
Copyright
© The authors. All rights reserved. This is a privileged document currently under peer-review/community review (or an accepted/rejected manuscript). Authors have provided JMIR Publications with an exclusive license to publish this preprint on it's website for review and ahead-of-print citation purposes only. While the final peer-reviewed paper may be licensed under a cc-by license on publication, at this stage authors and publisher expressively prohibit redistribution of this draft paper other than for review purposes.