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

NCT06153706 | Completed Phase 2

• 1 other identifier: #6/22
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Periodontitis

Outcome Measures

Primary Outcomes (6)

• 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

Study Arms (2)

L-PFR loaded with medical grade metronidazole

EXPERIMENTAL

Drug: Subgingival application of L-PRF loaded with metronidazole

L-PFR

ACTIVE COMPARATOR

Other: Subgingival application of L-PRF

Interventions

Subgingival application of L-PRF loaded with metronidazole DRUG

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.

L-PFR loaded with medical grade metronidazole

Subgingival application of L-PRF OTHER

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

L-PFR

Eligibility Criteria

• Age: 25 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yasmeen Khaled: lead

Study Sites (1)

Faculty of Dentistry, Alexandria University

Alexandria, Egypt

Location

Related Publications (1)

• Omar YK, Rashidy MAE, Ahmed GB, Aboulela AG. Evaluation of leukocyte-platelet rich fibrin as an antibiotic slow-release biological device in the treatment of moderate periodontitis: a randomized controlled clinical trial. BMC Oral Health. 2024 Dec 21;24(1):1530. doi: 10.1186/s12903-024-05254-x.

  PMID: 39709402 DERIVED

MeSH Terms

Conditions

Periodontitis

Interventions

Metronidazole

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Nitroimidazoles; Nitro Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Yasmeen K Omar, BDS

  Alexandria University

  PRINCIPAL INVESTIGATOR

• Mohy A El Rashidy, PhD

  Alexandria University

  STUDY DIRECTOR

• Ghada Bassiouny, PhD

  Alexandria University

  STUDY CHAIR

• Aliaa G Aboulela, PhD

  University of Alexandria

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Periodontology Masters degree candidate

Study Record Dates

• First Submitted: November 23, 2023
• First Posted: December 1, 2023
• Study Start: June 1, 2022
• Primary Completion: October 1, 2023
• Study Completion: October 1, 2023
• Last Updated: December 1, 2023

Record last verified: 2023-11

Locations

EG (1)