TriamcinolonePhase 4NCT05660694
Comparison of Triamcinolone With Pentoxifylline and Vitamin- E Efficacy in the Treatment of Stage 2 and 3 Oral Submucous Fibrosis
A Phase 4 study testing Triamcinolone and Pentoxifylline with Vitamin E in people with Triamcinolone and Pentoxifylline, run by Altamash Institute of Dental Medicine at 1 site in Pakistan.
Trial summary
To compare the efficacy of Triamcinolone with Pentoxifylline and Vitamin E in patients with stage two and three oral submucous fibrosis. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Triamcinolone, Pentoxifylline, Vitamin E
- What is being tested?
- Triamcinolone and Pentoxifylline with Vitamin E
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jan 2020to 30 Sep 2021
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patients with clinically diagnosed OSMF who have not undergone any treatment of OSMF in past
- Patients willing to quit their tobacco chewing habit, gutkha areca nut smoking
- Patients who are ready to attend regular follow-ups
Who cannot join
- Patients who have undergone any treatment for OSF in past
- Patients with any evidence of cardiac, gastrointestinal, kidney, metabolic disorders, pregnant and lactating women's
- Patients with any co-existing disorder of the orofacial region other than OSF which may interfere with the study protocol
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Triamcinolone With Pentoxifylline and Vitamin- E Efficacy in the Treatment of Stage 2 and 3 Oral Submucous Fibrosis: A Clinical Trial
To compare the efficacy of Triamcinolone with Pentoxifylline and Vitamin E in patients with stage two and three oral submucous fibrosis.
Read the detailed description
To compare the efficacy of Triamcinolone with Pentoxifylline and Vitamin E in patients with stage two and three oral submucous fibrosis.
It was a randomized control clinical trial to compare efficacy of injection steroids versus pentoxifylline and vitamin E in the treatment of stage 2 and 3 OSF patient. Total 40 patients who presented with signs and symptoms of OSF were enrolled in our study that was evaluated over the period of (January 2020 to September 2021). Parameters taken in the study were age and mouth opening. Descriptive statistics and paired t-test were used for statistical analysis.
- Conditions
- Triamcinolone, Pentoxifylline, Vitamin E, Oral Submucosa Fibrosis, Tumor
- Being tested
- Triamcinolone, Pentoxifylline with Vitamin E
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TriamcinoloneDrug
Comparison of Triamcinolone with Pentoxifylline and Vitamin- E Efficacy
Pentoxifylline with Vitamin EDrug
Comparison of Triamcinolone with Pentoxifylline and Vitamin- E Efficacy
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Triamcinolone | Experimental | Injection steroid Triamcinolone 400mg with lidocaine 1:1 was given twice a week for 4 weeks in bi-lateral buccal mucosa in multiple sites Receives: Drug: Triamcinolone |
| Group 2: Pentoxifylline with Vitamin E | Experimental | Pentoxifylline 40mg twice a day along with vitamin E supplement one tablet per day for 4 weeks Receives: Drug: Pentoxifylline with Vitamin E |
What is being measured
The primary outcome is the main question the study is designed to answer.
Group 1: Triamcinolone measuring mouth opening using calibrated Vernier Caliper
Measuring mouth opening measuring mouth opening using calibrated Vernier Caliper by recording in millimeters the maximum mouth opening
Measured: 21 months
Group 2: Pentoxifylline with Vitamin E measuring mouth opening using calibrated Vernier Caliper
Measuring mouth opening measuring mouth opening using calibrated Vernier Caliper by recording in millimeters the maximum mouth opening
Measured: 21 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2022
- Study start1 Jan 2020
- Primary completion30 Sep 2021
- Study completion30 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TriamcinoloneStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Group 1: Triamcinolone Group 2: Pentoxifylline
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Altamash Institute of Dental Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abhishek Lal, Altamash Institute of Dental Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05660694
- Sponsor's protocol ID
- Treatment of OSF stage 2 and 3
- Status last verified
- Dec 2022
- First submitted
- 4 Dec 2022
- Last updated
- 21 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Triamcinolone With Pentoxifylline and Vitamin- E Efficacy in the Treatment of Stage 2 and 3 Oral Submucous Fibrosis: A Clinical Trial
- ClinicalTrials.gov ID
- NCT05660694
- Acronym / sponsor ID
- Treatment of OSF stage 2 and 3
- Conditions
- Triamcinolone, Pentoxifylline, Vitamin E, Oral Submucosa Fibrosis, Tumor
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Altamash Institute of Dental MedicineUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 30 Sep 2021 (actual)
- Study completion
- 30 Sep 2021 (actual)
- First posted
- 21 Dec 2022 (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.
To compare the efficacy of Triamcinolone with Pentoxifylline and Vitamin E in patients with stage two and three oral submucous fibrosis.
Detailed description
To compare the efficacy of Triamcinolone with Pentoxifylline and Vitamin E in patients with stage two and three oral submucous fibrosis.
It was a randomized control clinical trial to compare efficacy of injection steroids versus pentoxifylline and vitamin E in the treatment of stage 2 and 3 OSF patient. Total 40 patients who presented with signs and symptoms of OSF were enrolled in our study that was evaluated over the period of (January 2020 to September 2021). Parameters taken in the study were age and mouth opening. Descriptive statistics and paired t-test were used for statistical analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Group 1: Triamcinolone Group 2: Pentoxifylline
| Arm | Type | Receives |
|---|---|---|
| Group 1: Triamcinolone | Experimental | Drug: TriamcinoloneInjection steroid Triamcinolone 400mg with lidocaine 1:1 was given twice a week for 4 weeks in bi-lateral buccal mucosa in multiple sites |
| Group 2: Pentoxifylline with Vitamin E | Experimental | Drug: Pentoxifylline with Vitamin EPentoxifylline 40mg twice a day along with vitamin E supplement one tablet per day for 4 weeks |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with clinically diagnosed OSMF who have not undergone any treatment of OSMF in past
- Patients willing to quit their tobacco chewing habit, gutkha areca nut smoking
- Patients who are ready to attend regular follow-ups
Key exclusion criteria (3 listed)
- Patients who have undergone any treatment for OSF in past
- Patients with any evidence of cardiac, gastrointestinal, kidney, metabolic disorders, pregnant and lactating women's
- Patients with any co-existing disorder of the orofacial region other than OSF which may interfere with the study protocol
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 |
|---|---|---|
| TriamcinoloneComparison of Triamcinolone with Pentoxifylline and Vitamin- E Efficacy | Drug | Group 1: Triamcinolone |
| Pentoxifylline with Vitamin EComparison of Triamcinolone with Pentoxifylline and Vitamin- E Efficacy | Drug | Group 2: Pentoxifylline with Vitamin E |
Primary outcome
Group 1: Triamcinolone measuring mouth opening using calibrated Vernier Caliper
Time frame: 21 months
Measuring mouth opening measuring mouth opening using calibrated Vernier Caliper by recording in millimeters the maximum mouth opening
Group 2: Pentoxifylline with Vitamin E measuring mouth opening using calibrated Vernier Caliper
Time frame: 21 months
Measuring mouth opening measuring mouth opening using calibrated Vernier Caliper by recording in millimeters the maximum mouth opening
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2022.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Triamcinolone and Pentoxifylline with Vitamin E in people with Triamcinolone and Pentoxifylline, run by Altamash Institute of Dental Medicine at 1 site in Pakistan.
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 3 inclusion and 3 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: finished, as of the sponsor's last update on 21 Dec 2022. 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 Pakistan. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Group 1: Triamcinolone measuring mouth opening using calibrated Vernier Caliper (time frame: 21 months). The study lists 2 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 21 Dec 2022.