An interventional study of Conventional Stabilizing Splint and Digital Stabilizing Splint in Temporomandibular Disorders (TMD), sponsored by Shifa Tameer-e-Millat University. Enrolling by invitation at 1 site in Pakistan. Open to participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2026-05-05.
Sponsored by Shifa Tameer-e-Millat University · Not applicable, Interventional, and Treatment
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.
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.
591 studies on the registry are indexed under Temporomandibular Joint Disorders; 149 are open to participants now.
This study's planned enrollment of 120 is above the median of 45 across 415 interventional studies indexed under Temporomandibular Joint Disorders.
Browse Temporomandibular Joint Disorders studies →Shifa Tameer-e-Millat University is the lead sponsor of 27 studies on the registry; 10 are open to participants now.
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Exclusion Criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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 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.
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.
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.
Time frame: Baseline to 3 months post-intervention
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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
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.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — 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.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, 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.
Started Jan 2026 (actual). Primary completion is estimated for Sep 2026, 8 months after the start.
Of 242 non-industry interventional studies with no phase under Temporomandibular Joint Disorders, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 21. This study's planned 8 months is below that.
Counting every sponsor, half of 246 studies reached it within 10 months; a quarter within 5 and three quarters within 21.
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