Evaluation of L-PRF as an Antibiotic Slow-release Biological Device in the Treatment of Moderate Periodontitis

Yasmeen Khaled24 enrolled

Overview

This study aimed to evaluate the efficacy of leukocyte platelet-rich fibrin (L-PRF) as a local sustained released device for antibiotics.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Periodontitis

Interventions

Subgingival application of L-PRF loaded with metronidazoleDRUG

After phase I therapy, L-PRF loaded medical grade metronidazole was applied sub gingivally into the pockets using blunt gauge needle and Perio-pack was placed (two applications with one week apart were applied subgingivally.

Subgingival application of L-PRFOTHER

The L-PRF alone was applied subgingivally into the pockets and Perio-pack was placed (two applications with one week apart.

Eligibility

Sex: ALLMin age: 25 YearsMax age: 50 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients suffering from stage II periodontitis with probing depth and exhibiting bleeding on probing. * Patients showing good oral hygiene. * No history of periodontal therapy (surgical and non-surgical) for the past 6 months. Exclusion Criteria: * Patients with known systemic and debilitating diseases. * Patients who had any previous adverse reactions to the products (or similar products) used in this study. * Patients who have any autoimmune diseases. * Patients who have any known disease that interfere with periodontal procedure. * Smokers. * Pregnancy and lactating women. * Use of antibiotics during the last 6 months.

Locations (1)

Faculty of Dentistry, Alexandria University

Alexandria, Egypt

Outcomes

Primary Outcomes

Plaque accumulation

This was assessed using O'Leary plaque index which is based on the visible continuous plaque along the gingival margin after staining. Four or six sites per tooth were examined, and the percentage of tooth surfaces exhibiting stained plaque was calculated. The score ranges from 0% (no plaque) to 100% (abundant plaque)

Time frame: up to 6 months

Gingival inflammation

This was assessed using modified gingival index which uses a visual scale to assess gingival health. It relies on a visual assessment of gingival changes to measure the severity of inflammation. Five categories, using a 0-4 scale, score the marginal and papillary gingival tissue based on color, texture, edema, and spontaneous bleeding. Using this index, 108 sites are scored per person (52 papillary and 56 marginal sites). Score 0 indicates normal gingival, score 1: mild inflammation with slight changes in color and texture, but not in all portions of gingival marginal or papillary, score 2: Mild inflammation with slight changes in color and texture in all portions of gingival marginal or papillary, score 3: Moderate bright surface inflammation, erythema, edema, and/or hypertrophy of gingival marginal or papillary, and score 4: Severe inflammation with erythema, edema, and/or marginal gingival hypertrophy of the unit or spontaneous bleeding, papillary, congestion, or ulceration

Time frame: up to 6 months

Bleeding on probing

This was assessed using bleeding index which assesses bleeding on probing. The number of sites where bleeding is recorded is divided by the total number of available sites in the mouth and multiplied by 100 to express the bleeding index as a percentage. The score ranges from 0% (no bleeding) to 100% (bleeding in all sites)

Time frame: up to 6 months

Probing depth

The distance measured (mm) using a periodontal probe from the base of the pocket to the most apical point on the gingival margin. It dictates the patient's ability to maintain optimal plaque control. Probing depths in excess of 3mm are an indication for periodontal therapy.

Time frame: up to 6 months

Data from ClinicalTrials.gov

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