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

NCT ID: NCT06153706

Last Updated: 2023-12-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-01

Study Completion Date

2023-10-01

Brief Summary

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

Detailed Description

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Conditions

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Periodontitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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L-PFR loaded with medical grade metronidazole

Group Type EXPERIMENTAL

Subgingival application of L-PRF loaded with metronidazole

Intervention Type 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

Group Type ACTIVE_COMPARATOR

Subgingival application of L-PRF

Intervention Type OTHER

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

Interventions

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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.

Intervention Type DRUG

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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

25 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yasmeen Khaled

OTHER

Sponsor Role lead

Responsible Party

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Yasmeen Khaled

Periodontology Masters degree candidate

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Yasmeen K Omar, BDS

Role: PRINCIPAL_INVESTIGATOR

Alexandria University

Mohy A El Rashidy, PhD

Role: STUDY_DIRECTOR

Alexandria University

Ghada Bassiouny, PhD

Role: STUDY_CHAIR

Alexandria University

Aliaa G Aboulela, PhD

Role: STUDY_CHAIR

University of Alexandria

Locations

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Faculty of Dentistry, Alexandria University

Alexandria, , Egypt

Site Status

Countries

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Egypt

References

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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.

Reference Type DERIVED
PMID: 39709402 (View on PubMed)

Other Identifiers

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#6/22

Identifier Type: -

Identifier Source: org_study_id