Digital vs Conventional Stabilizing Splints in Temporomandibular Disorders

A Randomized Controlled Trial Comparing Digitally Fabricated and Conventional Stabilizing Splints in the Management of Temporomandibular Disorders

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Temporomandibular Disorders (TMD)
• Intervention / Treatment: Device: Conventional Stabilizing Splint; Device: Digital Stabilizing Splint

Detailed Description

This study is a parallel-group randomized controlled clinical trial designed to evaluate the effect of fabrication technique on the clinical performance of stabilization splints in patients with temporomandibular disorders (TMD). Eligible participants will be diagnosed according to Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) Axis I criteria. Following informed consent, participants will be randomly assigned in a 1:1 ratio to either the digitally fabricated splint group or the conventionally fabricated splint group using a computer-generated randomization sequence. Allocation concealment will be ensured by sequentially generated numbered, opaque, sealed envelopes prepared by an independent investigator.

For the digital workflow, maxillary and mandibular arches will be captured using an intra oral scanner. Splints will be designed using computer-aided design software and fabricated using additive manufacturing (three-dimensional printing) with biocompatible resin materials via digital light processing (DLP) technology. Post-processing will include cleaning and light curing according to standardized protocols.

For the conventional workflow, impressions will be obtained using elastomeric materials, followed by cast fabrication and articulation. Stabilization splints will be fabricated using heat-cured acrylic resin according to standardized laboratory procedures.

To ensure comparability between groups, splint design parameters will be standardized. All appliances will be maxillary full-coverage stabilization splints with even and simultaneous bilateral contacts in centric relation and canine-guided occlusion during excursive movements. Splint thickness will be standardized (approximately 2-3 mm), and all appliances will be adjusted intraorally at delivery to achieve uniform occlusal contacts.

Participants will be instructed to wear the splints nightly for a minimum of 8 hours. Clinical evaluations will be conducted at baseline and 3 months post-intervention. Outcome assessment will be performed by an examiner blinded to group allocation.

Data will be analyzed using IBM SPSS Statistics (version 26.0; IBM Corp., Armonk, NY, USA). A two-sided p-value < 0.05 will be considered statistically significant.. Normality will be assessed using the Shapiro-Wilk test. Between-group comparisons will be performed using independent t-tests or Mann-Whitney U tests, as appropriate. Within-group comparisons will be conducted using paired t-tests or Wilcoxon signed-rank tests. Repeated measures will be analyzed using repeated measures ANOVA or mixed-effects models.

This study is designed to isolate the effect of fabrication technique by controlling splint design variables while employing clinically relevant material systems, thereby providing evidence on the comparative effectiveness of digitally fabricated and conventionally fabricated stabilization splints in the management of temporomandibular disorders.

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Islamabad
    • Islamabad, Islamabad, Pakistan, 2500
      • Shifa College of Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Conventional Stabilizing Splints Group; 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; 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.
Experimental: Digital Stabilizing Splints Group; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Pain-Related Disability	Change in Pain-related disability will be assessed using the disability component of the Graded Chronic Pain Scale (GCPS), which includes three items evaluating interference with daily activities, social activities, and work, each scored on a 0-10 scale. The mean of these items is multiplied by 10 to generate a disability score ranging from 0 to 100, where higher scores indicate greater disability. The outcome measure is the mean change in disability score from baseline to 3 months post-intervention.	Baseline to 3 months post-intervention
Change in maximum mouth opening (MMO)	Maximum mouth opening will be measured as the maximum unassisted inter-incisal distance (in millimeters) using a calibrated ruler or digital caliper. Measurements will be obtained under standardized conditions at each assessment visit. The outcome measure is the mean change in MMO (mm) from baseline to 3 months post-intervention, where higher values indicate improved mandibular function.	Baseline to 3 months post-intervention
Change in Jaw Functional Limitation	Functional limitation will be assessed using the Jaw Functional Limitation Scale (JFLS-20), a validated patient-reported outcome measure consisting of 20 items evaluating mastication, vertical jaw mobility, and emotional and verbal expression. Each item is scored on a 0-10 scale, and the total score is calculated as the mean of all items, resulting in a score ranging from 0 to 10, where higher scores indicate greater functional limitation. The outcome measure is the mean change in JFLS-20 score from baseline to 3 months post-intervention.	Baseline to 3 months post-intervention
Resolution of Temporomandibular joint (TMJ) clicking	Resolution of TMJ clicking will be assessed clinically during mandibular opening and closing movements by a trained examiner under standardized conditions. Clicking will be recorded as a dichotomous variable (present/absent) based on the presence of an audible or palpable click during at least one of three consecutive mandibular opening-closing cycles. The outcome measure is the proportion of participants demonstrating resolution of TMJ clicking (present at baseline and absent at 3 months post-intervention).	Baseline and 3 months post intervention
Change in oral health-related quality of life	Oral health-related quality of life will be assessed using the Oral Health Impact Profile-14 (OHIP-14), a validated questionnaire consisting of 14 items evaluating functional limitation, physical pain, psychological discomfort, physical disability, psychological disability, social disability, and handicap. Each item is scored on a 5-point Likert scale (0 = never to 4 = very often), with total scores ranging from 0 to 56, where higher scores indicate worse oral health-related quality of life. The outcome measure is the mean change in OHIP-14 total score from baseline to 3 months post-intervention.	Baseline to 3 months post-intervention
Compliance with splint use	Compliance with splint use will be assessed based on patient-reported average nightly wear time (hours per night), recorded using a standardized daily log. Participants will document the number of hours the splint is worn each night throughout the study period. The outcome measure is the mean average nightly wear time (hours/night) over the 3-month follow-up period.	From intervention (day of splint delivery) to 3 months post-intervention, with compliance recorded continuously and summarized as average nightly wear time at 3 months.

Collaborators and Investigators

• Sponsor: Shifa Tameer-e-Millat University
• Investigators: Study Director: Prof Anwar Ali Shah, BDS, PhD, M-Orth, FDSRCS, Shifa Tameer-e-Millat University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2026
• Primary Completion (Estimated): September 26, 2026
• Study Completion (Estimated): October 26, 2026

Study Registration Dates

• First Submitted: March 16, 2026
• First Submitted That Met QC Criteria: April 27, 2026
• First Posted (Actual): May 5, 2026

Study Record Updates

• Last Update Posted (Actual): May 5, 2026
• Last Update Submitted That Met QC Criteria: April 27, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Occlusal splints; stabilizing splints; Three dimensional Printing; Temporomandibular joint Disorder; Temporomandibular Disorders (TMD)
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Stomatognathic Diseases; Muscular Diseases; Joint Diseases; Jaw Diseases; Mandibular Diseases; Craniomandibular Disorders; Temporomandibular Joint Disorders
• Other Study ID Numbers: IRB 243-25; 053-2025 (Other Grant/Funding Number: Shifa Tameer-e-millat University)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified individual participant data (IPD) underlying the results reported in this study, including baseline characteristics, outcome measures, and relevant covariates, will be made available. The study protocol and statistical analysis plan will also be shared.

IPD Sharing 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

IPD Sharing 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.

• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No