Injectable Platelet Rich Fibrin With Non Surgical Periodontal Therapy

Comparative Evaluation of Local Injectable Platelet Rich Fibrin and Hyaluronic Acid as Adjunctive to Non Surgical Periodontal Therapy: a Randomized Placebo Controlled Clinical Trial

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.

Study Overview

• Status: Unknown
• Conditions: CHRONIC PERIODONTITIS
• Intervention / Treatment: Other: Placebo gel; Drug: Hyaluronic acid gel; Biological: Platelet rich fibrin

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 Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Negative control; Placebo gel	Other: Placebo gel; Localized subgingival application; Other Names: Cellulose gel
EXPERIMENTAL: Test group 1; Hyaluronic acid gel	Drug: Hyaluronic acid gel; Localized subgingival application
EXPERIMENTAL: Test group 2; injectable prf	Biological: Platelet rich fibrin; Localized subgingival application

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical attachment level (CAL)	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")	3 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Probing pocket depth	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")	3 Months

Collaborators and Investigators

• Sponsor: Institute of Dental Sciences, Bareilly, Uttar Pradesh, India

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): August 28, 2019
• Primary Completion (ANTICIPATED): November 28, 2019
• Study Completion (ANTICIPATED): January 25, 2020

Study Registration Dates

• First Submitted: August 23, 2019
• First Submitted That Met QC Criteria: August 26, 2019
• First Posted (ACTUAL): August 28, 2019

Study Record Updates

• Last Update Posted (ACTUAL): August 28, 2019
• Last Update Submitted That Met QC Criteria: August 26, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis; Chronic Periodontitis; Physiological Effects of Drugs; Immunologic Factors; Protective Agents; Adjuvants, Immunologic; Viscosupplements; Hyaluronic Acid
• Other Study ID Numbers: IEC/IDS50/2019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes