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Completed

NCT Number: NCT06153706

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

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

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Key information

Conditions

Periodontitis Mouth Diseases Periodontal Diseases Stomatognathic Diseases

Age range

25 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Faculty of Dentistry, Alexandria University

Alexandria, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Plaque accumulation

    Time frame: up to 6 months

    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)

  2. Gingival inflammation

    Time frame: up to 6 months

    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

  3. Bleeding on probing

    Time frame: up to 6 months

    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)

  4. Probing depth

    Time frame: up to 6 months

    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.

  5. Clinical attachment loss

    Time frame: up to 6 months

    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

  6. Quantitative assessment of Porhyromonas gingivalis

    Time frame: up to 6 months

    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.

Sponsors and collaborators

Lead sponsor

Yasmeen Khaled

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Dec 1, 2023
Registry last updated
Dec 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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