Health Condition 1: K135- Oral submucous fibrosis
Conditions
Interventions
Intervention1: Dexamethasone bioadhesive (mucoadhesive) patch: Dexmethasone sodium phosphate loaded mucoadhesive patch (2mg/patch) to be pasted in bilateral buccal mucosa biweeky for 6 weeks - 12 patc
Sponsors
Dr Shilpa Shree K R
Eligibility
Inclusion criteria
Inclusion criteria: 1. Clinically diagnosed cases of Oral Submucous fibrosis 2. Willing to participate in the study
Exclusion criteria
Exclusion criteria: 1.Previously treated and Stage IVb OSMF cases 2.Other fibrosis conditions like scleroderma, scarring, post radiation therapy 3.Immunocompromised patients and other systemic disorders like hypertension and diabetes mellitus 4.Not willing to participate in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Significant Decrease in the VAS score, Increase in the interincisal distance (mouth opening) and decrease in the submucosal thickness (measured via USG) in intervention group than comparator groupTimepoint: Baseline,3rd week, 6th week | — |
Secondary
| Measure | Time frame |
|---|---|
| Better patient compliance in study group than comparator group as mucoadhesive patch is non invasive, painless and sustained release formulationTimepoint: baseline, after 6th week | — |
Countries
India
Contacts
Public ContactDr S Jayachandran MDS PhD FDSRCPSGlasg
Tamilnadu Government Dental College and Hospital
Outcome results
None listed