Comparison of Conventional,3D Printed and Novel Hybrid Stabilization Splints in the Management of Temporomandibular Joint Disorders
Comparative Efficacy of Conventional, 3D-Printed, and Novel Hybrid Stabilization Splints in the Management of Temporomandibular Joint Disorders: A Randomized Clinical Trial
1 other identifier
interventional
36
1 country
1
Brief Summary
Occlusal splint therapy is a well-established conservative approach for the management of temporomandibular disorders (TMDs); however, variability in clinical outcomes suggests that no single splint design is universally optimal. Conventional chairside stabilization splints are widely used and allow immediate intraoral adjustments; however, they are technique-sensitive and may compromise long-term fit and patient comfort. Conversely, 3D-printed occlusal splints provide superior precision, reproducibility, and material stability; however, their uniformly rigid structure may limit initial comfort and patient compliance, particularly in patients with acute pain or muscle tenderness. To address these limitations, the researchers intend to develop an innovative hybrid occlusal splint i.e. Dual material 3D printed stabilization splint, that integrates both hard and soft components. This design aims to combine the biomechanical stability and occlusal precision characteristic of rigid splints with the cushioning effect and enhanced comfort provided by soft splints. The objective is to improve adaptation, compliance, and the sustained therapeutic efficacy of the splint.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Aug 2026
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 7, 2026
CompletedFirst Posted
Study publicly available on registry
August 12, 2026
CompletedStudy Start
First participant enrolled
August 16, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2027
Study Completion
Last participant's last visit for all outcomes
December 31, 2027
August 12, 2026
August 1, 2026
1.2 years
August 7, 2026
August 7, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Visual Analog Scale (VAS)
To evaluate and contrast pain relief by using the Visual Analog Scale (VAS).The scale ranges from 0 to 10 where 0 is the minimum VAS score and 10 is the maximum score. Score of 0 indicates no pain and score of 10 indicates maximum pain intensity.
Baseline, 1 week, 2 weeks, 4 weeks
Maximum Mouth Opening
To evaluate functional improvement by Measuring the change in Maximum Mouth Opening (MMO) in millimetres from baseline to 1 month.
Baseline, 1 week, 2 weeks, 4 weeks
Maximum Bite Force
To quantify masticatory efficiency by measuring changes in Maximum Bite Force (MBF) using a bite force analyser device.
baseline, 1 week, 2 weeks, 4 weeks
Secondary Outcomes (1)
Patient Compliance
Baseline, 1 week, 2 weeks, 4 weeks
Study Arms (3)
Conventional Stabilization Splints
ACTIVE COMPARATORPatients will be given conventional hard stabilization splints.
3D Printed stabilization splints
ACTIVE COMPARATORPatients will be given single material 3D printed stabilization splints made of PETG.
Hybrid Stabilization Splint
EXPERIMENTALPatients will be given Novel Hybrid stabilization splints made of PETG and TPU.
Interventions
Conventional chairside stabilization splints for treatment of temporomandibular joint disorders.
3d printed stabilization splint for treatment of temporomandibular joint disorders.
3d printed hybrid stabilization splint for treatment of temporomandibular joint disorders.
Eligibility Criteria
You may qualify if:
- Patients presenting with clinical symptoms of TMJ pain disorders were diagnosed using the DC/TMD criteria.
- Age between 18 and 60.
- The same number of original molars was used to avoid affecting periodontal proprioception and bite force.
- The Patient's consent to participate in the study.
You may not qualify if:
- Pregnancy
- Not willing to participate in the study
- Healing disorders or systemic diseases where healing is compromised.
- Allergic to PMMA, TPU, PETG or any other 3D printing or conventional prosthetic material.
- Patients with epilepsy or any other neurological disorders.
- Systemic Arthritis or any other osteo-degenerative disorder.
- Acute TMJ trauma or fracture in \< 30 days.
- Any obvious dental decay or periodontal disease to which fascial pain could be attributed.
- Patient with psychiatric disorder or on anti-anxiety or anti-depressant drugs.
- Patients with dental implants.
- Any systemic condition associated with widespread pain such as in fibromyalgia.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Post Graduate Institute of Dental Sciences, Rohtak
Rohtak, Haryana, 124001, India
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Dr. Harneet Singh, MDS
Post Graduate Institute of Dental Sciences, Rohtak
Central Study Contacts
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
- SPONSOR
Study Record Dates
First Submitted
August 7, 2026
First Posted
August 12, 2026
Study Start (Estimated)
August 16, 2026
Primary Completion (Estimated)
October 31, 2027
Study Completion (Estimated)
December 31, 2027
Last Updated
August 12, 2026
Record last verified: 2026-08