Injectable autologus platelet concentrate as an adjunct to periodontal flap surgery in the management of periodontitis

Phase 3

Not yet recruiting

• Conditions: Chronic periodontitis,

• Registration Number: CTRI/2022/11/047236
• Lead Sponsor: Dr Keerthana Varma KC

Brief Summary

Periodontitis is a chronic inflammatory disease that causes destruction of the tooth-attachment apparatus. The aim of regenerative periodontal therapy is to restore the structure and function of the periodontium. The objective of this prospective intervention trial is to assess the effectiveness of adjunctive i PRF application along with open flap debridement in the treatment of periodontal osseous defects not indicated for regenerative therapy. Otherwise healthy adults with moderate to severe periodontitis who satisfy the  inclusion and exclusion criteria will be randomised to test and control group. Baseline clinical parameters will be compared with post treatment periodontal parameters 6months after the therapy. Conclusions will be drawn based on results. The aim of this interventional clinical trial is to assess the clinical effectiveness of i-PRF in improving healing outcomes in horizontal defects by comparing it with conventional open flap debridement. This study is such an attempt whereby an inexpensive material which do not cause any allergic reaction can be used for treatment of horizontal bone defects.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2022-10-20
• Study Start: 2022-11-17

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1)Adults above 18years diagnosed with periodontitis (according to AAP,2017 classification) with residual probing pocket depth (PPD) ≥ 5 mm after step 1 and 2 therapy (non surgical phase) in at least two adjacent interproximal sites in either of the jaws 2) Systemically healthy subjects 3) Deep pockets associated with horizontal bone defects that are not indicated for regenerative therapy 4) Full Mouth Bleeding Score ≤ 30 % & Full Mouth Plaque Score ≤ 20%.

Exclusion Criteria

1. Current tobacco users 2) Subjects taking medications affecting the periodontium (Bisphosphonates ,Calcium channel blockers ,cyclosporine ,phenytoin, steroids) 3) Pregnancy or lactation 4) Antibiotic medication in the last 3 months 5) Grade II/III furcation involvement 6) Infra bony defects that are indicated for resective or regenerative therapy.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Probing pocket depth reduction	6 months

Secondary Outcome Measures

Name	Time	Method
1)Clinical attachment gain	2)Gingival recession

Trial Locations

Locations (1)

Government Dental College , Kottayam; 🇮🇳 Kottayam, KERALA, India

Government Dental College , Kottayam

🇮🇳Kottayam, KERALA, India

Dr Keerthana Varma KC

Principal investigator

7510448235

keerthanavarma95@gmail.com