Effects of Prosthetic Rehabilitation on Temporomandibular Disorders: Protocol for a Randomized Controlled Trial
Bibliographic record
Abstract
BACKGROUND: Loss of teeth or occlusal imbalance is one of the proposed dental risk factors for temporomandibular disorders (TMDs). Losing some non-free-end teeth cause the original occluding tooth/teeth to supraerupt from the original upright position and causes neighboring tooth/teeth to shift in an angle, causing biomechanical imbalance on the mandible. Based on these sequelae, rehabilitation of missing teeth is the first step in managing TMD in edentulous patients. Even though the prevalence of TMD in association with edentulism and in rehabilitated patients has been increasing, proper guidelines for the management of such cases have not been established. This study describes the protocol to analyze the effect of prosthetic rehabilitation on patients with TMD. OBJECTIVE: This study aims to determine the effectiveness of prosthetic rehabilitation in the reduction of pain in edentulous patients with TMD and to determine the effect of the span of edentulism, the number of quadrants involved, pathological migration, the type of Kennedy classification, and the prosthetic status on temporomandibular joint dysfunction signs and symptoms. METHODS: In this randomized controlled trial, 300 patients diagnosed with TMD will be grouped into one of the three interventional groups based on the type of their edentulous state. The interventional groups are (1) partially edentulous arch: Kennedy Class I and II (prosthetic rehabilitation without splint); (2) partially edentulous arch: Kennedy Class III and IV (prosthetic rehabilitation with a splint); and (3) completely edentulous arches (prosthetic rehabilitation without splint). All three of the mentioned interventional groups have corresponding control groups that will receive symptomatic treatment and comprehensive counseling. The measured primary outcomes are pain and electromyogram, and the secondary outcomes include pain drawing, Graded Chronic Pain Scale, Jaw Functional Limitation Scale, Oral Behaviours Checklist, depression, physical symptoms, and anxiety. The outcome measurements will be recorded at baseline and at the end of 24 hours, 7 days, 28 days, and 3 months. RESULTS: Ethical approval was obtained from the Institutional Review Board of Amrita Institute of Medical Sciences, Kochi, India. Study participants' recruitment began in May 2021 and is expected to conclude in March 2023. This clinical trial protocol was developed based on the SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) 2013 Statement. CONCLUSIONS: The purpose of this study is to gather data on prosthetic rehabilitation as a treatment for TMD. Obtaining this goal will aid in the development of evidence-based therapy protocols for prosthetic rehabilitation in TMD management. TRIAL REGISTRATION: Clinical Trials Registry - India CTRI/2020/06/026169; http://ctri.nic.in/Clinicaltrials/pdf_generate.php?trialid=42381. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/33104.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.030 | 0.036 |
| Meta-epidemiology (narrow) | 0.007 | 0.003 |
| Meta-epidemiology (broad) | 0.016 | 0.006 |
| Bibliometrics | 0.003 | 0.004 |
| Science and technology studies | 0.003 | 0.004 |
| Scholarly communication | 0.004 | 0.003 |
| Open science | 0.003 | 0.002 |
| Research integrity | 0.010 | 0.008 |
| Insufficient payload (model declined to judge) | 0.058 | 0.007 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".