CTRI/2025/07/090547Not yet recruitingNot Applicable
Therapeutic Effectiveness of Virgin Coconut Oil versus Chlorhexidine in the Management of Recurrent Aphthous Ulcer in Children: A Randomized Clinical Trial.
Department of Pediatric and Preventive Dentistry1 site in 1 country48 target enrollmentStarted: July 25, 2025Last updated:
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 48
- Locations
- 1
- Primary Endpoint
- 1.Pain Reduction
Study Overview
Brief Summary
This is a randomized single-blinded interventional trial, comparing the effectiveness of Virgin Coconut Oil and Chlorhexidine gel in managing Recurrent aphthous ulcers in children aged 11-14 years. A total of 48 participants will be equally divided into two groups. Outcomes like Pain, ulcer size and erythema will be measured on day 0,1,3 and 7. The study uses block randomization with sealed envelope allocation. The study is expected to be completed by one year.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Outcome Assessor Blinded
Eligibility Criteria
- Ages
- 11.00 Year(s) to 14.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Children with recurrent minor oral aphthous ulcers (up to 6mm).
Exclusion Criteria
- •1.Patients with a history of any systemic disease 2.Traumatic ulcers 3.Patients on any recent topical or systemic antibiotics or analgesics 4.History of dental surgery within one month.
Outcomes
Primary Outcomes
1.Pain Reduction
Time Frame: Day 0 (Baseline) | Day 1 | Day 3 | Day 7
2.Ulcer size reduction
Time Frame: Day 0 (Baseline) | Day 1 | Day 3 | Day 7
3.Erythema level
Time Frame: Day 0 (Baseline) | Day 1 | Day 3 | Day 7
Secondary Outcomes
- Complete Healing Achieved(Day 7)
Investigators
Aysha Lubna Salim
Kannur Dental College
Study Sites (1)
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