Temporomandibular Disorders (TMDs)NCT07760428
Comparison of Conventional,3D Printed and Novel Hybrid Stabilization Splints in the Management of Temporomandibular Joint Disorders
A study testing Conventional Stabilization Splints, 3d printed Stabilization splint and Novel hybrid stabilization splint in people with Temporomandibular Disorders (TMDs) and Myofascial Pain - Dysfunction Syndrome of TMJ, run by Postgraduate Institute of Dental Sciences Rohtak at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Temporomandibular Disorders (TMDs), Myofascial Pain - Dysfunction Syndrome of TMJ, Myofascial Pain Dysfunction Syndrome, Temporomandibular Joint
- What is being tested?
- Conventional Stabilization Splints, 3d printed Stabilization splint and Novel hybrid stabilization splint
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteIndia
- Study dates
- 16 Aug 2026to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
India1 site
Post Graduate Institute of Dental Sciences, Rohtak
Rohtak, Haryana, 124001
Dr. Harneet Singh, MDS, +919034900501, drambikagupta79@rediffmail.com
About this study
Official title: Comparative Efficacy of Conventional, 3D-Printed, and Novel Hybrid Stabilization Splints in the Management of Temporomandibular Joint Disorders: A Randomized Clinical Trial
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.
Read the detailed description
Temporomandibular disorders (TMDs) are a diverse group of musculoskeletal and neuromuscular conditions affecting the temporomandibular joint (TMJ), masticatory muscles, and associated structures, leading to pain, functional limitations, and impaired quality of life.5 They encompass more than 30 different conditions that may involve the TMJ, the surrounding masticatory muscles (such as the masseter, temporalis, and pterygoid muscles), or a combination of both.Occlusal splints have long been a cornerstone of TMD management due to their reversibility, simplicity, and efficacy in redistributing occlusal forces, reducing bruxism, and promoting neuromuscular adaptation.16 Understanding their diverse presentation, underlying risk factors, and biopsychosocial context is essential for effective assessment, diagnosis, and management.
- Conditions
- Temporomandibular Disorders (TMDs), Myofascial Pain - Dysfunction Syndrome of TMJ, Myofascial Pain Dysfunction Syndrome, Temporomandibular Joint, Anterior Disc Displacement
- Being tested
- Conventional Stabilization Splints, 3d printed Stabilization splint, Novel hybrid stabilization splint
- Keywords
- occlusal splints, temporomandibular disorders, temporomandibular joint disorders, muscle pain, myofascial pain, 3d printed occlusal splints, FDM
- Medical subject headings
- Temporomandibular Joint Disorders, Temporomandibular Joint Dysfunction Syndrome, Myalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional Stabilization SplintsDevice
Conventional chairside stabilization splints for treatment of temporomandibular joint disorders.
3d printed Stabilization splintDevice
Also called 3d printed single material stabilization splint
3d printed stabilization splint for treatment of temporomandibular joint disorders.
Novel hybrid stabilization splintDevice
Also called novel hybrid dual material stabilization splint
3d printed hybrid stabilization splint for treatment of temporomandibular joint disorders.
| Study group | Role | What they receive |
|---|---|---|
| Conventional Stabilization Splints | Active comparator | Patients will be given conventional hard stabilization splints. Receives: Device: Conventional Stabilization Splints |
| 3D Printed stabilization splints | Active comparator | Patients will be given single material 3D printed stabilization splints made of PETG. Receives: Device: 3d printed Stabilization splint |
| Hybrid Stabilization Splint | Experimental | Patients will be given Novel Hybrid stabilization splints made of PETG and TPU. Receives: Device: Novel hybrid stabilization splint |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: baseline, 1 week, 2 weeks, 4 weeks
Secondary outcomes (1)
Patient Compliance
To evaluate patient compliance and comfort using Likert Scale. The Likert Scale is a 5-point scale where 1 is the minimum score and 5 is the maximum score. Score 1 indicates very dissatisfied and Score 5 indicates very satisfied.
Measured: Baseline, 1 week, 2 weeks, 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2026
- Study start16 Aug 2026 (estimated)
- Primary completion31 Oct 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Temporomandibular Disorders (TMDs)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Postgraduate Institute of Dental Sciences Rohtak
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dr. Harneet Singh, MDS, Study director, Post Graduate Institute of Dental Sciences, Rohtak
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07760428
- Sponsor's protocol ID
- Subhadeepa Omr 26/39
- Status last verified
- Aug 2026
- First submitted
- 7 Aug 2026
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Efficacy of Conventional, 3D-Printed, and Novel Hybrid Stabilization Splints in the Management of Temporomandibular Joint Disorders: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07760428
- Acronym / sponsor ID
- Subhadeepa Omr 26/39
- Conditions
- Temporomandibular Disorders (TMDs), Myofascial Pain - Dysfunction Syndrome of TMJ, Myofascial Pain Dysfunction Syndrome, Temporomandibular Joint, Anterior Disc Displacement
- Keywords
- occlusal splints, temporomandibular disorders, temporomandibular joint disorders, muscle pain, myofascial pain, 3d printed occlusal splints, FDM
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Postgraduate Institute of Dental Sciences RohtakUniversity, hospital or other
- Study start
- 16 Aug 2026 (estimated)
- Primary completion
- 31 Oct 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 12 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Temporomandibular disorders (TMDs) are a diverse group of musculoskeletal and neuromuscular conditions affecting the temporomandibular joint (TMJ), masticatory muscles, and associated structures, leading to pain, functional limitations, and impaired quality of life.5 They encompass more than 30 different conditions that may involve the TMJ, the surrounding masticatory muscles (such as the masseter, temporalis, and pterygoid muscles), or a combination of both.Occlusal splints have long been a cornerstone of TMD management due to their reversibility, simplicity, and efficacy in redistributing occlusal forces, reducing bruxism, and promoting neuromuscular adaptation.16 Understanding their diverse presentation, underlying risk factors, and biopsychosocial context is essential for effective assessment, diagnosis, and management.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Conventional Stabilization Splints | Active comparator | Device: Conventional Stabilization SplintsPatients will be given conventional hard stabilization splints. |
| 3D Printed stabilization splints | Active comparator | Device: 3d printed Stabilization splintPatients will be given single material 3D printed stabilization splints made of PETG. |
| Hybrid Stabilization Splint | Experimental | Device: Novel hybrid stabilization splintPatients will be given Novel Hybrid stabilization splints made of PETG and TPU. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conventional Stabilization SplintsConventional chairside stabilization splints for treatment of temporomandibular joint disorders. | Device | Conventional Stabilization Splints |
| 3d printed Stabilization splintAlso: 3d printed single material stabilization splint3d printed stabilization splint for treatment of temporomandibular joint disorders. | Device | 3D Printed stabilization splints |
| Novel hybrid stabilization splintAlso: novel hybrid dual material stabilization splint3d printed hybrid stabilization splint for treatment of temporomandibular joint disorders. | Device | Hybrid Stabilization Splint |
Primary outcome
Visual Analog Scale (VAS)
Time frame: Baseline, 1 week, 2 weeks, 4 weeks
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.
Maximum Mouth Opening
Time frame: Baseline, 1 week, 2 weeks, 4 weeks
To evaluate functional improvement by Measuring the change in Maximum Mouth Opening (MMO) in millimetres from baseline to 1 month.
Maximum Bite Force
Time frame: baseline, 1 week, 2 weeks, 4 weeks
To quantify masticatory efficiency by measuring changes in Maximum Bite Force (MBF) using a bite force analyser device.
1 secondary outcome
Patient Compliance
Time frame: Baseline, 1 week, 2 weeks, 4 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dr. Harneet Singh, MDS study director
Post Graduate Institute of Dental Sciences, Rohtak
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional Stabilization Splints, 3d printed Stabilization splint and Novel hybrid stabilization splint in people with Temporomandibular Disorders (TMDs) and Myofascial Pain - Dysfunction Syndrome of TMJ, run by Postgraduate Institute of Dental Sciences Rohtak at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dr. Subhadeepa Paul (+918638461860, Subhadeepa01@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale (VAS) (time frame: Baseline, 1 week, 2 weeks, 4 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2026.