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Digital vs Conventional Stabilizing Splints in Temporomandibular Disorders

NCT07566936 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2026-05-05

No results posted yet for this study

Summary

This randomized controlled trial aims to compare the clinical effectiveness of digitally fabricated and conventionally fabricated maxillary stabilization splints in patients diagnosed with Temporomandibular Disorders (TMD) according to Diagnostic Criteria for Temporomandibular Disorders (DC/TMD).

Participants will be randomly allocated in a 1:1 ratio to receive either a Digitally fabricated splint produced using computer-aided design and three-dimensional printing technology or a conventionally fabricated splint using standard impression and laboratory techniques.

The primary outcome is Change in Pain Intensity measured using the Characteristic Pain Intensity component of the Graded Chronic Pain Scale (GCPS), 0-100 scale. Higher scores indicate greater pain severity from baseline to 3 months as primary end point.

Secondary outcomes include change in pain-related disability assessed using the Graded Chronic Pain Scale (GCPS) disability score, change in maximum mouth opening measured in millimeters (mm), change in jaw functional limitation assessed using the Jaw Functional Limitation Scale (JFLS), resolution of temporomandibular joint (TMJ) clicking (present/absent), change in oral health-related quality of life assessed using the Oral Health Impact Profile-14 (OHIP-14), and compliance with splint use measured as average nightly wear time (hours per night).

Assessments will be conducted at baseline and 3 months post-intervention. Outcome assessment will be performed by a blinded examiner.

Conditions

  • Temporomandibular Disorders (TMD)

Interventions

DEVICE

Conventional Stabilizing Splint

A conventional stabilizing splint is a removable dental appliance that fits over the upper or lower teeth. It is made using traditional laboratory methods from heat cure acrylic material based on a standard impression of the patient's teeth.

DEVICE

Digital Stabilizing Splint

A digital stabilizing splint is a removable appliance that fits over the teeth and is made using digital scanning and three dimensional printing technology. A digital scan of the patient's teeth is used to design the splint on a computer, and it is then fabricated using three dimensional printing technology using a biocompatible material.

Sponsors & Collaborators

  • Shifa Tameer-e-Millat University

    lead OTHER

Principal Investigators

  • Prof Anwar Ali Shah, BDS, PhD, M-Orth, FDSRCS · Shifa Tameer-e-Millat University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-01
Primary Completion
2026-09-26
Completion
2026-10-26

Countries

  • Pakistan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07566936 on ClinicalTrials.gov