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comparison of two drugs in oral sub mucous fibrosis

Comparative evaluation of Platelet Rich Plasma (PRP) versus Triamcinolone Acetonide and Hyaluronidase combination in the treatment of Oral Submucous Fibrosis.

Status
Active, not recruiting
Phases
Phase 3Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/10/046263
Enrollment
22
Registered
2022-10-07
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: - Health Condition 2: R478- Other speech disturbances

Interventions

Intervention1: triamcinolone acetonide and hyaluronidase: After allocation of the patients, Group B patients will be treated with intralesional injection of the combination of Triamcinolone Acetonide

Sponsors

Dr Ajay Kumar
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patient above the age of 17 years to 65 years. 2. Patients clinically diagnosed with grade II and III OSMF patients (Clinical staging by Laiââ?¬•s, 1995). 3. Patients who had not undergone any treatment for OSMF in the past 1 year. 4. Cooperative patients. 5. Patients without any systemic illness. 6. Patients who were willing to quit gutkha, arecanut and/or tobacco chewing habit. 7. Patients who agreed for regular follow ups.

Exclusion criteria

Exclusion criteria: 1. OSMF patients with coexisting uncontrolled systemic illness. 2. Patients who had received previous treatment. 3. Patients with other mucosal/potentially medically disorders such as leukoplakia or lichen planus. 4. Patients with history of drug allergy. 5. Pregnant or breastfeeding women. 6. Patients not consenting to participate.

Design outcomes

Primary

MeasureTime frame
1.Burning sensation 2.Mouth opening 3 cheek flexibility Timepoint: burning sensation in terms of visual analog scale will be measured at baseline and after every week of follow up for 4 weeks . mouth opening and cheek flexibility in terms of mm will be recorded at baseline and after each week for 4 weeks.

Secondary

MeasureTime frame
1.Cheek flexibility Timepoint: 1.Increase of Cheek flexibility in 2nd and 3rd visit

Countries

India

Contacts

Public ContactDr Ajay Kumar

Faculty of dental sciences,ims,bhu

adit@bhu.ac.in9451525522

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026