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Comparison of the efficacy of various treatment modalities in the management of mouth opening, burning sensation in oral submucous fibrosis

Efficacy of treatment modalities of oral submucous fibrosis at clinical and histopathological level-Comparing intralesional corticosteroids in combination with hyaluronidases therapy, soft LASER (ErCr:YSGG)fibrotomy and intralesional autologous platelet-rich-plasma - A Prospective Randomized Clinical Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/12/048322
Enrollment
84
Registered
2022-12-20
Start date
Unknown
Completion date
Unknown
Last updated
2023-01-09

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

Conditions

Health Condition 1: K135- Oral submucous fibrosis

Interventions

Intervention1: Platelet rich plasma therapy: Autologous PRP 5ml will be given intralesionally in submucosal plane at multiple sites of palpable fibrous bands at about 0.5ml per 1cm2 using 25-gauge nee

Sponsors

Dr M Mary Sujatha
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. The individuals who gave a positive history of Areca nut/ Ghutka / Betel Quid chewing. 2. The criteria for the presence of the disease according to clinical staging and clinical inspection:Burning sensation, the presence of fibrous bands, Restricted mouth opening. 3. Histologically proven oral submucous fibrosis.

Exclusion criteria

Exclusion criteria: 1 Patient with blood-borne diseases 2 Medically compromised patients 3 Anti-coagulant therapy 4 Immunosuppressive therapy 5 Critical thrombocytopenia (low platelet count) 6 Hypofibrinogenemia. 7 Hemodynamic instability 8 Individuals with history of any systemic disease and undergoing treatment. 9 Individuals not willing to be a part of study

Design outcomes

Primary

MeasureTime frame
To know efficacy of the each treatment modality Intralesional Injections, PRP injections, Laser therapy in Oral submucous fibrosis clinically in reduction of fibrous bands, burning sensation of mouth increase in mouth opening.Timepoint: 1. Reduction of fibrous bands: 1, 2, 3, 4, 5, 6 weeks and 3, 6, 9 months. 2. Reduction in burning sensation of mouth: 1, 2, 3, 4, 5, 6 weeks and 3, 6, 9 months. 3. Increase in mouth opening: 1, 2, 3, 4, 5, 6 weeks and 3, 6, 9 months.

Secondary

MeasureTime frame
NilTimepoint: Nil

Countries

India

Contacts

Public ContactDr T Ramesh

Vishnu Dental College and Hospital

drramesht@gmail.com9440847997

Outcome results

None listed

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