Evaluation of Additive Efficacy of Hyaluronic acid with Melatonin gel in papilla reconstruction post flap surgery.
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Papillary Width
Study Overview
Brief Summary
Open flap debridement is a gold standard treatment for treatment of periodontitis but often creates black triangle. Loss of interdental papilla then becomes a sequale of flap surgeries. Hyaluronic acid is potent in soft tissue augmentation as they are insoluble, resist degradation, does not migrate and retain water content. Melatonin increases VEGF expression, which is a potent angiogenic modulator by exerting a significant pro angiogenic activity. It has antioxidant , anti microbial property that might help in repair of both soft and hard tissue. It also stimulates collagen type I proliferation.Thus, use of melatonin with hyaluronic acid in treatment of papilla reconstruction might provide with better outcomes. This study aims to determine the papilla reconstruction using hyaluronic acid and melatonin combination post flap surgery.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Participant and Outcome Assessor Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 45.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •1 Patients among 18 – 45 years of age who has undergone flap surgery within 3 months of interval.
- •2 Patients with esthetic concern; 3 Having adequate width of attached gingiva 4 The sites with a distance 7 mm from the interdental contact point to the interproximal bone crest and a probing depth of 4 mm at the defective papillary sites were considered for inclusion.
- •5 Food lodgment in the anterior embrasure; with Class I and Class II papillary loss (Nordland & Tarnow classification, 1982).
Exclusion Criteria
- •1 Patient who received radiotherapy, chemotherapy, immunosuppressive treatments, systemic corticosteroids and/or anticoagulants the 30 days prior to intervention.
- •2 Patients with known history of allergy having known history of allergy, systemic or blood borne diseases undergoing orthodontic treatment.
- •3 prolonged treatment with non-steroidal anti-inflammatory drugs (NSAIDs) or similar medications.
- •4 smokers; lactating or pregnant females.
- •5 presence of any restoration in maxillary or mandibular anterior region.
Outcomes
Primary Outcomes
Papillary Width
Time Frame: Baseline | 3months | 6months
Papillary Deficient Height
Time Frame: Baseline | 3months | 6months
Width of keratinized gingiva
Time Frame: Baseline | 3months | 6months
Deficient Area
Time Frame: Baseline | 3months | 6months
Secondary Outcomes
- Probing depth(Clinical attachment levels)
Investigators
Dr Nivedha N
Department of Periodontology