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Enrolling by Invitation

NCT Number: NCT07566936

Digital vs Conventional Stabilizing Splints in 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.

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Key information

Conditions

Temporomandibular Disorders (TMD) Craniomandibular Disorders Jaw Diseases Joint Diseases Mandibular Diseases Muscular Diseases Musculoskeletal Diseases Stomatognathic Diseases Temporomandibular Joint Disorders

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shifa College of Dentistry

Islamabad, 2500, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Change in Pain Intensity

    Time frame: Baseline to 3 months post-intervention

    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.

Secondary outcomes

  1. Change in Pain-Related Disability

    Time frame: Baseline to 3 months post-intervention

    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.

  2. Change in maximum mouth opening (MMO)

    Time frame: Baseline to 3 months post-intervention

    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.

  3. Change in Jaw Functional Limitation

    Time frame: Baseline to 3 months post-intervention

    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.

  4. Resolution of Temporomandibular joint (TMJ) clicking

    Time frame: Baseline and 3 months post intervention

    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).

  5. Change in oral health-related quality of life

    Time frame: Baseline to 3 months post-intervention

    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.

  6. Compliance with splint use

    Time frame: 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.

    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.

Sponsors and collaborators

Lead sponsor

Shifa Tameer-e-Millat University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
May 5, 2026
Registry last updated
May 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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