Health Condition 1: Z000- Encounter for general adult medical examination
Conditions
Interventions
Intervention1: Topical Oxygen Therapy (Oxygen-releasing gel applied to oral mucosa): Topical Oxygen Therapy An oxygen-releasing gel formulation applied locally to the affected oral mucosal area. The
Sponsors
Dr J Nithya devi
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients aged 18 years and above. 2. Individuals presenting with clinically diagnosed recurrent aphthous stomatitis 3. Patients with no systemic conditions that may interfere with wound healing (e.g., uncontrolled diabetes, immunosuppressive disorders).
Exclusion criteria
Exclusion criteria: 1. Patients below 18 years of age. 2. Presence of systemic diseases that can impair wound healing (e.g., uncontrolled diabetes, immunodeficiency, autoimmune disorders). 3. Patients with any allergic, malignant or potentially malignant oral lesions. 4. Pregnant or lactating women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome is the rate and extent of oral mucosal healing following the intervention, assessed through clinical evaluation of lesion size, tissue appearance, and symptom relief.Assessments will be conducted at baseline (Day 0), weekly during the initial 3 weeks, and then at 1, 3, 6, 9, and 12 months to monitor long-term healing, recurrence, and sustained treatment effectiveness.Timepoint: Baseline (Day 0): Before starting the intervention Week 1 (Day 7): Early assessment of healing progress Week 2 (Day 14): Mid-point assessment Week 3 (Day 21): Final assessment of complete healing provide more details | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean change in pain intensity (VAS 0 10) % reduction in lesion surface area from baseline; Time to complete clinical healing (days); % of participants requiring rescue analgesic medication; Incidence of local adverse events (irritation, burning, allergy); Timepoint: Day 3, Day 7, Day 14, Day 21 Day 7, Day 14, Day 21 Up to Day 21 Day 21 | — |
Countries
India
Contacts
Public ContactJ Nithya devi
Karpaga Vinayaga Institute of dental sciences
Outcome results
None listed