Injectable Platelet Rich Fibrin With Non Surgical Periodontal Therapy

Not Applicable

• Conditions: CHRONIC PERIODONTITIS
• Interventions: Other: Placebo gel; Drug: Hyaluronic acid gel; Biological: Platelet rich fibrin

• Registration Number: NCT04070729
• Lead Sponsor: Institute of Dental Sciences, Bareilly, Uttar Pradesh, India

Brief Summary

Clinical evaluation of local subgingival application of injectable platelet-rich fibrin ( i-PRF ) for chronic periodntitis as adjunctive to non surgical therapy and compare it with hyaluronic acid.

120 periodontal patients will receive a scaling and root planing ( non surgical periodontal therapy). Equal number of patients will receive subgingival application of i-PRF, hyaluronic acid or placebo gel as the adjunction to non surgical therapy.

Detailed Description

The aim of the study is to evaluate and compare the clinical efficacy of subgingival application of i-PRF and hyaluronic acid gel as adjunctive to non-surgical periodontal therapy. 120 periodontal patients will receive traditional mechanical supra and subgingival scaling and root planing. Patients were randomly allocated in three groups. Group 1, 2 and 3 will receive subginigval application of placebo, hyaluronic acid gel and i prf respectively. Clinical parameters will be evaluated: plaque index (PI), gingival index (GI), bleeding on probing (BOP), probing depth (PD), clinical attachment level (CAL), gingival recession (GR). Clinical measurements will be performed at baseline, 1 month and at 3 months.

Study Timeline

• Status Verified: 2019-08
• Study First Submitted: 2019-08-23
• Study First Submitted QC: 2019-08-26
• Last Update Submitted: 2019-08-26
• Study Start: 2019-08-28
• Study First Posted: 2019-08-28
• Last Update Posted: 2019-08-28
• Primary Completion: 2019-11-28
• Study Completion: 2020-01-25

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Patients are in general good health.
• Patients having minimum of 20 permanent teeth.
• They have not taken medication known to interfere with periodontal tissue health or healing in the preceding 6 months.
• Presence of periodontal pockets (≥5 mm) and clinicala ttachment level > 5 mm.

Exclusion Criteria

• Immunosuppressive systemic diseases (like cancer, AIDS, diabetes etc.)
• Clotting and Hematological disorders
• Patients with grade III mobility.
• Patients with smoking and alcohol consuming habit.
• Pregnant and lactating female.
• Medications influence on the gingival and periodontal tissues (like calcium channel blockers, or Long-term steroid use)
• The teeth with poor filling and ill fitted restorations

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Negative control	Placebo gel	Placebo gel
Test group 1	Hyaluronic acid gel	Hyaluronic acid gel
Test group 2	Platelet rich fibrin	injectable prf

Primary Outcome Measures

Name	Time	Method
Clinical attachment level (CAL)	3 Months	Measure as the change in distance from the cementoenamel junction to the bottom of the gingival sulcus by using a periodontal probe (UNC 15 "University of North Carolina")

Secondary Outcome Measures

Name	Time	Method
Probing pocket depth	3 Months	Measure as the change in distance from the gingival margin GM to the bottom of the gingival sulcus by using a periodontal probe (UNC 15 "University of North Carolina")