Injectable Platelet Rich Fibrin With Non Surgical Periodontal Therapy

NCT ID: NCT04070729

Last Updated: 2019-08-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-08-28
• Study Completion Date: 2020-01-25

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.

Conditions

CHRONIC PERIODONTITIS

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Negative control

Placebo gel

Group Type: PLACEBO_COMPARATOR

Placebo gel

Intervention Type: OTHER

Localized subgingival application

Test group 1

Hyaluronic acid gel

Group Type: EXPERIMENTAL

Hyaluronic acid gel

Intervention Type: DRUG

Localized subgingival application

Test group 2

injectable prf

Group Type: EXPERIMENTAL

Platelet rich fibrin

Intervention Type: BIOLOGICAL

Localized subgingival application

Interventions

Placebo gel

Localized subgingival application

Intervention Type: OTHER

Hyaluronic acid gel

Localized subgingival application

Intervention Type: DRUG

Platelet rich fibrin

Localized subgingival application

Intervention Type: BIOLOGICAL

Other Intervention Names

Cellulose gel

Eligibility Criteria

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Institute of Dental Sciences, Bareilly, Uttar Pradesh, India

OTHER

Sponsor Role: lead

Responsible Party

ASHISH AGARWAL

Clinical professor, institute of dental sciences, bareilly

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

IEC/IDS50/2019

Identifier Type: -

Identifier Source: org_study_id