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

Evaluation of L-PRF as an Antibiotic Slow-release Biological Device in the Treatment of Moderate Periodontitis (A Randomized Controlled Clinical Trial)

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

Study Overview

• Status: Completed
• Conditions: Periodontitis
• Intervention / Treatment: Drug: Subgingival application of L-PRF loaded with metronidazole; Other: Subgingival application of L-PRF

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Egypt
  • Alexandria, Egypt
    • Faculty of Dentistry, Alexandria University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: L-PFR loaded with medical grade metronidazole	Drug: Subgingival application of L-PRF loaded with metronidazole; 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.
Active Comparator: L-PFR	Other: Subgingival application of L-PRF; The L-PRF alone was applied subgingivally into the pockets and Perio-pack was placed (two applications with one week apart.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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	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)	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.	up to 6 months
Clinical attachment loss	It represents the extent of periodontal support that has been lost around a tooth and is measured with the periodontal probe as the distance (mm) from the cemento-enamel junction to the base of the pocket	up to 6 months
Quantitative assessment of Porhyromonas gingivalis	Relative quantitation of Porhyromonas gingivalis counts was performed by Real Time PCR. Subgingival plaque samples were calculated, DNA was isolated and quantified for standardizing the polymerase chain reaction.	up to 6 months

Collaborators and Investigators

• Sponsor: Yasmeen Khaled
• Investigators: Principal Investigator: Yasmeen K Omar, BDS, Alexandria University; Study Director: Mohy A El Rashidy, PhD, Alexandria University; Study Chair: Ghada Bassiouny, PhD, Alexandria University; Study Chair: Aliaa G Aboulela, PhD, University of Alexandria

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2022
• Primary Completion (Actual): October 1, 2023
• Study Completion (Actual): October 1, 2023

Study Registration Dates

• First Submitted: November 23, 2023
• First Submitted That Met QC Criteria: November 23, 2023
• First Posted (Estimated): December 1, 2023

Study Record Updates

• Last Update Posted (Estimated): December 1, 2023
• Last Update Submitted That Met QC Criteria: November 23, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis; Anti-Infective Agents; Anti-Bacterial Agents; Antiprotozoal Agents; Antiparasitic Agents; Metronidazole
• Other Study ID Numbers: #6/22

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No