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Can a hybrid 3D-Printed splint ease jaw pain better than traditional ones?

NCT ID NCT07760428

Symptom relief Sponsor: Postgraduate Institute of Dental Sciences Rohtak Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 12, 2026 · Last updated Aug 13, 2026 · Updated 1 time

Summary

This trial tests whether a new type of dental splint—made with both hard and soft 3D-printed materials—can improve comfort and outcomes for people with temporomandibular joint (TMJ) disorders. It compares the hybrid splint to conventional chairside splints and standard 3D-printed rigid splints. Participants will be randomly assigned to one of the three splint types, and researchers will measure pain, jaw opening, bite force, and patient satisfaction over one month.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Three types of dental splints: conventional chairside splints, 3D-printed rigid splints, and a novel hybrid 3D-printed splint combining hard and soft materials.
What this could lead to
If the hybrid splint works as hoped, it could offer a more comfortable and effective treatment for jaw pain and dysfunction, improving patient compliance and outcomes.
What could go wrong
This is a small, early-stage trial with only 36 participants, so results may not apply broadly. The hybrid splint may not prove superior to existing options, and individual responses can vary.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 36 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 60 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

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Conditions

The condition(s) this trial relates to.

Myalgia temporomandibular joint disorder temporomandibular joint dysfunction syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Anterior disc displacement Myofascial pain - dysfunction syndrome of TMJ Myofascial pain dysfunction syndrome, temporomandibular joint Temporomandibular disorders (TMDS)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Post Graduate Institute of Dental Sciences, Rohtak

    Rohtak, Haryana, 124001, India

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