Comparative Evaluation of the Effects of Injectable Platelet Rich Fibrin(i-PRF) on Rate of Maxillary Canine Retraction – A Split Mouth Randomized Trial
Overview
- Phase
- Phase 2/3
- Status
- Not yet recruiting
- Sponsor
- Dr Himanshu Kumar Sah
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Rate of canine retraction will compared in the experimental group and control group.
Overview
Brief Summary
A split-mouth, randomized controlled trial will be conducted using a single-center, single-blinded (outcome assessor), parallel, double-arm design with a 1:1 allocation ratio. A total of 20 patients undergoing fixed appliance therapy who meet the inclusion and exclusion criteria will be recruited for the study. In the experimental group, 2 ml of injectable platelet-rich fibrin (i-PRF) will be infiltrated into the buccal submucosa, and 1 ml of i-PRF will be infiltrated into the palatal submucosa. No i-PRF injection will be administered in the control group. The rate of canine retraction will be assessed and compared between both the groups at three time points: T0 (baseline), T1 (after 1 month), and T2 ( after 2 months). Additionally, three-dimensional control (transverse, sagittal, and vertical), as well as gingival and periodontal health of the canine and molar teeth, will be evaluated and compared using the Plaque Index, Gingival Index, Modified Sulcular Bleeding Index, and Pocket Depth at T0, T1, and T2. The data will be analyzed using appropriate statistical analysis.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Outcome Assessor Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 25.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Patients with Class I bimaxillary protrusion and Class II Division 1 malocclusion requiring extraction of maxillary first premolar.
- •Fully erupted permanent dentition (except third molars).
- •Patient with good oral hygiene.
Exclusion Criteria
- •Pregnant women.
- •Patients with impacted or blocked canine.
- •Patients with systemic disease.
- •Coagulation disorders or being treated with anticoagulants.
- •Patients who had previous orthodontic treatment or had radiographic evidence of bone resorption.
Outcomes
Primary Outcomes
Rate of canine retraction will compared in the experimental group and control group.
Time Frame: Rate of canine retraction will be evaluated at T0 (baseline),T1 (after 1 month) and T2 (after 2 months) intervals.
Secondary Outcomes
- 1. To determine and compare the three-dimensional control (transverse, sagittal and vertical) of canine and molar.(2. To determine gingival and periodontal health of canine and molar.)
Investigators
Dr Himanshu Kumar Sah
Chhattisgarh Dental College and Research Institute GE Road Sundra Rajnandgaon CG 491441