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New combo therapy aims to unlock stiff jaws in oral disease

NCT ID NCT07277998

Disease control Sponsor: Karachi Medical and Dental College 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether alternating injections of a steroid (triamcinolone) and platelet-rich plasma (PRP) can improve mouth opening and reduce burning pain in people with oral submucous fibrosis, a condition that causes stiffness and can lead to cancer. Forty adults with moderate to severe disease will receive either the alternating therapy or steroid alone over 12 weeks. The goal is to see if combining anti-inflammatory and regenerative treatments works better than the standard approach.

What this could mean

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

Active substance
Triamcinolone acetonide and platelet-rich plasma (PRP) injections
What this could lead to
If it works, this could offer a better way to improve mouth opening and reduce pain for people with oral submucous fibrosis, potentially slowing disease progression.
What could go wrong
This is a small, early-stage trial with only 40 participants, so results may not apply to everyone. The alternating treatment may not work better than the standard steroid alone.

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 40 people

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

Expected to start

Mar 2026

An estimate. Start dates often move.

Expected to finish

Sep 2026

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 65 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: Clinically diagnosed Oral Submucous Fibrosis (OSF), Stage II-IV using Haider et al. classification. Age 18-65 years. Mouth opening ≤ 30 mm. Persistent burning sensation (VAS ≥ 3). Able and willing to comply with weekly therapy sessions. Provided written informed consent. Exclusion Criteria: Previous treatment with PRP, Platelet-rich Fibrin (PRF), corticosteroid, or combination therapy in the last 6 months. Systemic diseases affecting wound healing (e.g., uncontrolled diabetes, severe anemia). Current steroid therapy or immunosuppressive therapy. Oral lesions suspicious for malignancy or recurrent Oral Squamous cell carcinoma (OSCC). Bleeding disorders or platelet count \<150,000. Pregnant or breastfeeding women. Known allergy to local anesthetics or triamcinolone. Patients unwilling to stop areca nut/tobacco habits.

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Conditions

The condition(s) this trial relates to.

Fibrosis oral submucous fibrosis Paresthesia Trismus

As listed by the trial registrant

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

Oral submucous fibrosis

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

  • Abbasi Shaheed Hospital

    Karachi, Sindh, 71510, Pakistan

More trials for these conditions

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