A RANDOMIZED CONTROLLED CLINICAL TRIAL TO COMPARE THE EFFICACY OF AN ALLOPLAST WITH OR WITHOUT “ADVANCED-PRF+” USING MINIMALLY INVASIVE SURGICAL TECHNIQUE IN THE MANAGEMENT OF PERIODONTAL INFRABONY DEFECTS
Trial Snapshot
- Phase
- Phase 1/2
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- ii. Amount of defect fill
Study Overview
Brief Summary
RESEARCH QUESTION
Whether alloplast alone or in combination along with “A-PRF+” using Minimally Invasive Surgical Technique (MIST) is more effective in treatment of periodontal infrabony defects.
AIM AND OBJECTIVES
AIM :- To evaluate the efficacy of alloplast alone or in combination with “A-PRF+” in the treatment of periodontal infrabony defects using minimally invasive surgical technique (MIST).
OBJECTIVES :-
1) To evaluate clinically and radiologically the efficacy of alloplast alone in treatment of periodontal infrabony defects using minimally invasive surgical technique.
2) To evaluate clinically and radiologically the efficacy of alloplast along with “A-PRF+” in treatment of periodontal infrabony defects using minimally invasive surgical technique.
3) To compare clinically and radiologically the efficacy of use of alloplast vs alloplast along with “A-PRF+” in the treatment of periodontal infrabony defects using minimally invasive surgical technique.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Investigator Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 60.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Patients with age more than or equal to 18 with periodontitis.
- •Patients with at least one or more sites with periodontal probing depth (PD) more than or equal to 5 mm when measured using a manual periodontal probe (UNC 15) and CAL more than or equal to 5 mm.
- •Radiographic presence of at least one infrabony osseous defect having depth more than or equal to 3 mm as measured.
- •Patients who will have full-mouth plaque score(FMPS) and full-mouth bleeding score(FMBS) less than or equal to 20 percent
- •Patients who will give consent for participation in the study and shall also be available for all follow periods.
Exclusion Criteria
- •Patients with any known systemic disease and drug or medication or therapeutic regimen that might interfere with wound healing of soft tissue or bone.
- •Patients who have habit of smoking and or consuming alcohol.
- •Patients allergic to any drug and or material, used in the study.
- •Patients unable or unwilling to undergo surgical procedure.
- •Patients who are pregnant or lactating females.
- •Patients who had undergone periodontal treatment in the previous 6 months.
- •Patients with parafunctional habits such as bruxism.
- •Defect sites with teeth having more than or equal to Grade II furcation involvement.
- •Defect Sites with teeth having mobility more than or equal to Grade III.
- •Defect sites around third molar.
Outcomes
Primary Outcomes
ii. Amount of defect fill
Time Frame: baseline | 12 weeks | 24 weeks
iii. Percentage of defect fill
Time Frame: baseline | 12 weeks | 24 weeks
iv. Amount of defect resolution
Time Frame: baseline | 12 weeks | 24 weeks
v. Percentage of defect resolution
Time Frame: baseline | 12 weeks | 24 weeks
A. Clinical Parameters
Time Frame: baseline | 12 weeks | 24 weeks
i. Clinical attachment level (CAL)
Time Frame: baseline | 12 weeks | 24 weeks
ii. Pocket depth (PD)
Time Frame: baseline | 12 weeks | 24 weeks
B. Radiographic parameters
Time Frame: baseline | 12 weeks | 24 weeks
i. Defect depth
Time Frame: baseline | 12 weeks | 24 weeks
Secondary Outcomes
- Clinical Parameters-(i. Plaque index (PI))
Investigators
Dr Priyanshi
J.N Kapoor D.A.V Centenary Dental College
