Effectiveness of Oxitard Gel Versus Physiotherapeutic and Pharmacological Interventions in Alleviating Oral Submucous Fibrosis: A Phase-II Randomized Control Trial
NCT07921082, Phase 2, Not yet recruiting, Dow University of Health Sciences
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Effectiveness of Oxitard Gel Versus Physiotherapeutic and Pharmacological Interventions in Alleviating Oral Submucous Fibrosis: A Phase-II Randomized Control Trial | ClinicalTrials.gov |
| NCT number | NCT07921082 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Phases | Phase 2 | ClinicalTrials.gov |
| Enrollment | 20 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Dow University of Health Sciences | ClinicalTrials.gov |
| Conditions | Oral and Maxillofacial Conditions | ClinicalTrials.gov |
| Interventions | Herbal Formulation, Shekar's appliance, Multivitamin/Mineral supplements, Conventional oral physiotherapy exercises | ClinicalTrials.gov |
| First posted | 2026-11-06 | ClinicalTrials.gov |
| Last updated | 2026-11-06 | ClinicalTrials.gov |
Registered outcomes 4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Mouth opening | Measured at baseline and every 15 days for 3 months | Mouth opening (interincisal distance) What it shows: how far the patient can open their mouth. This is the main functional outcome, and it also sets the Haider functional stage. Tool: vernier caliper. How to measure: 1. Seat the patient upright with the head supported. 2. Ask them to open as wide as they can without pain. 3. Measure from the incisal edge of the upper central incisor to the incisal edge of the lower central incisor. 4. Use the same pair of teeth at every visit. Unit: millimetres. Improvement: the number goes up. | ClinicalTrials.gov |
| Primary | Burning sensation | Measured at baseline and every 15 days for 3 months | What it shows: how severe the patient's burning feels. It is the earliest symptom of the inflammation in OSMF. Tool: Visual Analogue Scale (VAS), a 10 cm line from 0 (no burning) to 10 (worst burning imaginable). How to measure: ask the patient to mark how much burning they feel, then read the score off the line. Some studies give spicy food as a challenge first; if you do this, use the same challenge at every visit. Unit: score from 0 to 10. Improvement: the score goes down | ClinicalTrials.gov |
| Primary | Cheek flexibility | Measured at baseline and every 15 days for 3 months | What it shows: how elastic the buccal mucosa is, which drops as fibrous bands form. Tool: vernier caliper or divider, plus a skin marker. How to measure: Mark V1 at the angle of the mouth. Draw an imaginary line from V1 to the tragus of the ear, and mark V2 one-third of the way along it. Measure V1 to V2 with the patient at rest. Ask the patient to blow out their cheeks fully, and measure V1 to V2 again. Cheek flexibility is the blown measurement minus the resting measurement. Unit: millimetres. Improvement: the difference gets bigger. | ClinicalTrials.gov |
| Primary | Tongue protrusion | Measured at baseline and every 15 days for 3 months | What it shows: how freely the tongue moves. Fibrosis of the tongue and floor of the mouth limits this. Tool: vernier caliper or a measuring scale. How to measure: 1. Ask the patient to stick the tongue out as far as they can. 2. Viewing from the side, measure from the incisal edges of the lower front teeth to the tip of the tongue. Unit: millimetres. Improvement: the number goes up. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 3
The papers the trial lists on ClinicalTrials.gov.
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)