Digital vs Conventional Stabilizing Splints in Temporomandibular Disorders

NCT07566936 | Enrolling By Invitation DMC

• 2 other identifiers: IRB 243-25053-2025
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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)

Keywords

Occlusal splints; stabilizing splints; Three dimensional Printing; Temporomandibular joint Disorder; Temporomandibular Disorders (TMD)

Outcome Measures

Primary Outcomes (1)

• Change in Pain Intensity

  Change in Pain intensity will be assessed using the Characteristic Pain Intensity (CPI) component of the Graded Chronic Pain Scale (GCPS). The CPI is calculated based on patient-reported current, worst, and average pain scores and is expressed on a 0-100 scale, where higher scores indicate greater pain intensity. The outcome measure is the mean change in CPI score from baseline to 3 months post-intervention.

  Baseline to 3 months post-intervention

Secondary Outcomes (6)

• Change in Pain-Related Disability

  Baseline to 3 months post-intervention

• Change in maximum mouth opening (MMO)

  Baseline to 3 months post-intervention

• Change in Jaw Functional Limitation

  Baseline to 3 months post-intervention

• Resolution of Temporomandibular joint (TMJ) clicking

  Baseline and 3 months post intervention

• Change in oral health-related quality of life

  Baseline to 3 months post-intervention

Study Arms (2)

Conventional Stabilizing Splints Group

ACTIVE COMPARATOR

Participants allocated to this arm will receive conventionally fabricated maxillary stabilizing splints produced using traditional fabrication techniques. Maxillary and mandibular impressions will be obtained using elastomeric impression material, followed by cast fabrication in dental stone. Jaw relation will be recorded using a facebow transfer and centric relation registration. Splints will be fabricated on a semi-adjustable articulator using heat-cured acrylic resin. Occlusion will be adjusted to achieve even bilateral contacts in centric relation with canine-guided or mutually protected occlusion. Participants will be instructed to wear the splint primarily during nighttime (minimum 8 hours daily). Necessary occlusal adjustments will be performed during follow-up visits.

Device: Conventional Stabilizing Splint

Digital Stabilizing Splints Group

EXPERIMENTAL

Participants allocated to this arm will receive digitally fabricated maxillary stabilizing splints . Intra oral scanning will be performed to obtain digital impressions of both arches. Jaw relation will be recorded digitally transferred into the software. Splints will be designed using specialized Computer aided design software to ensure uniform thickness and precise occlusal contacts. Fabrication will be carried out using digital fabrication technology that is three dimensional printing with biocompatible resin material. Post-insertion occlusal adjustments will be performed as needed to achieve even bilateral contacts in centric relation. Participants will be instructed to wear the splint primarily during nighttime (minimum 8 hours daily), similar to the conventional group.

Device: Digital Stabilizing Splint

Interventions

Conventional Stabilizing Splint DEVICE

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.

Conventional Stabilizing Splints Group

Digital Stabilizing Splint DEVICE

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.

Digital Stabilizing Splints Group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Adults aged 18-40 years
• Diagnosis of Temporomandibular Disorder (TMD) according to standardized Diagnostic Criteria for Temporomandibular disorders Axis I
• Maximum unassisted mouth opening between 20-30 mm
• Symptoms present for ≥3 months (to exclude transient/self-limiting cases)
• Willingness to comply with study protocol and provide informed consent

You may not qualify if:

• Diagnosis of temporomandibular joint myalgia or Myofascial pain as the primary condition
• History of trauma to the temporomandibular joint or mandible
• Presence of degenerative joint diseases (e.g., osteoarthritis, rheumatoid arthritis)
• Congenital or developmental craniofacial anomalies affecting temporomandibular joint
• Prior temporomandibular joint surgery or ongoing orthodontic treatment
• Current use of: Analgesics, muscle relaxants, or anti-inflammatory drugs affecting temporomandibular joint symptoms
• Prior Occlusal splint therapy within the last 3 months
• Systemic conditions affecting joint function (e.g., connective tissue disorders)
• Pregnancy or lactation (if intervention may influence compliance or physiology

Sponsors & Collaborators

• Shifa Tameer-e-Millat University: lead

Study Sites (1)

Shifa College of Dentistry

Islamabad, Islamabad, 2500, Pakistan

Location

MeSH Terms

Conditions

Temporomandibular Joint Disorders

Condition Hierarchy (Ancestors)

Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Stomatognathic Diseases

Study Officials

• Prof Anwar Ali Shah, BDS, PhD, M-Orth, FDSRCS

  Shifa Tameer-e-Millat University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Participants will be randomized in a 1:1 ratio to one of two parallel groups receiving either digitally fabricated or conventionally fabricated maxillary stabilization splints. Both groups will be managed under standardized clinical protocols, with identical follow-up schedules and outcome assessment procedures. Clinical evaluations will be conducted at baseline, and 3 months post-intervention. Allocation will remain fixed throughout the study period, with no crossover between interventions. Outcome assessment will be performed by a blinded examiner.

Study Record Dates

• First Submitted: March 16, 2026
• First Posted: May 5, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): September 26, 2026
• Study Completion (Estimated): October 26, 2026
• Last Updated: May 5, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data will be available from 6 months following publication to 2 years after publication. IPD Start Date: June 1, 2028 IPD End Date: June 1, 2030
• Access Criteria: Access to de-identified individual participant data (IPD), the study protocol, informed consent form, clinical study report and the statistical analysis plan will be granted to qualified researchers who submit a scientifically and methodologically sound research proposal. Requests will be reviewed by a committee comprising the principal investigator and an institutional research ethics representative. Approved researchers will be provided access to the requested data through a secure, controlled-access institutional repository after execution of a data sharing agreement outlining conditions of use, data security requirements, and publication policy. All data will be shared in compliance with Shifa Tameer-e-Millat University ethical guidelines and applicable data protection regulations.

Locations

PA (1)