Comparative evaluation of two minimally invasive techniques for the treatment of interdental papillary reconstruction using injectable PRF and 5%Hyaluronic acid gel-A Randomized controlled clinical trial
Overview
- Phase
- Phase 3 4
- Status
- Not yet recruiting
- Sponsor
- Bindu DR
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- 1) To assess the gain in papilla height after application of i-PRF in maxillary and mandibular IDP deficiencies from baseline to one month and four months.
Overview
Brief Summary
The study is a Randomized Controlled Clinical Trial with parallel group study design.the study is to evaluate the efficacy of injectable PRF and 5% hyaluronic acid gel in interdental papilla reconstruction.
The patients who have undergone periodontal flap surgery in the past with complaints of black triangles will be screened for the study. In the first session oral hygiene instructions will be rendered followed by thorough scaling. Clinical parameters will be recorded using a UNC-15 probe, and No 15 spreaders used for gingival thickness of interdental papillary deficiency.The occlusal stent for interdental papillary measurement will be fabricated with cold- cure clear acrylic resin on the cast model obtained from the alginate impression. The selected site will be anesthetized using topical lignocaine spray.In the test group prior to injection of i-PRF, the patient’s blood sample is drawn in i-PRF tube and immediately centrifuged at 700 rpm for 3 minutes, in centrifugation machine. The liquid form of i- PRF is taken in insulin syringe needle and inserted at a 45 degree angle in an area 2 mm apical to interdental papilla tip and injected to respective sites 2 mm apical to the coronal tip of the papilla.The procedure is repeated twice at a ten day interval. Patients will be followed for 1 and 4 months. Clinical parameters will be recorded in the above mentioned follow up time period. In the control group commercially available Hyaluronic acid gel will be injected using insulin syringe needle at the respective sites 2 mm apical to the coronal tip of the papilla. Similar follow up method will be carried out for test group.
Study Design
- Study Type
- Interventional
- Allocation
- Coin toss, Lottery, toss of dice, shuffling cards etc
- Masking
- None
Eligibility Criteria
- Ages
- 25.00 Year(s) to 45.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Subjects who have agreed to be participate voluntarily. 2) Males and females in the age group of
- •45 years. 3) Subjects who have undergone periodontal flap surgery at least before three months. 4) Class 1 and 2 interdental papilla loss (Nordland and Tarnow 1998). 5) Subjects with history of compliance to oral hygiene instructions.
Exclusion Criteria
- •A history of Subjects with known allergy to hyaluronic acid Pregnant & lactating woman.
- •Current Smokers.
Outcomes
Primary Outcomes
1) To assess the gain in papilla height after application of i-PRF in maxillary and mandibular IDP deficiencies from baseline to one month and four months.
Time Frame: Outcome assesments will be made at 3 timepoints during the study period. At Baseline, 1 month and 4 months.
2) To assess the gain in papilla height after application of injectable 5% Hyaluronic acid gel in maxillary and mandibular IDP deficiencies from baseline to one month and four months.
Time Frame: Outcome assesments will be made at 3 timepoints during the study period. At Baseline, 1 month and 4 months.
Secondary Outcomes
- To compare the gain in papilla height and clinical outcomes between the two groups, after application of iPRF and 5% Hyaluronic acid gel in maxillary and mandibular IDP deficiencies from baseline to one month and four months.(one year six months)
Investigators
Dr. Bindu D. R.
Dayananda Sagar College of Dental Sciences, Bangalore