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The Effect of Locally Dilvered Ciprofloxacine Loaded Injectable Platelet-rich Fibrin as an Adjunct to Non-surgical Periodontal Therapy on the Gingival Crevicular Level of Interleukin 6

NCT06968286 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-08-08

No results posted yet for this study

Summary

Sixty periodontally diseased patients will be enrolled in the study. After the patients are randomly divided into one of three treated groups, group 1 (n=20), SRP only; group 2 (n=20), SRP + i-PRF; and group 3 (n=20), P + Cip-loaded i-PRF. Clinical parameters (probing depth \[PD\], clinical attachment level \[CAL\], gingival index \[GI\], plaque index \[PI\], and level of IL6 in the GCF from baseline to 1 and 3 months of follow-up).

Conditions

  • Periodontitis Stage II

Interventions

PROCEDURE

SRP

participants with periodontitis treated with scaling and root planning

PROCEDURE

SRP+Injectable platelet rich fibrin

The iPRF will be prepared by the same operator according to the protocol developed by Miron and Choukron in 2017. It involves collecting 10 mL of intravenous blood from the participant using venipuncture of the antecubital vein under sterile conditions. The collected blood is transferred to a plain sterile test tube without anticoagulant and immediately subjected to centrifugation at 70-g force at 700 rpm for 3 minutes. After centrifugation, the blood separates into two parts: the bottom layer consists of a red blood cell compartment, and the top layer is platelet-rich fibrin plasma, which is still in liquid consistency. The top platelet-rich fibrin layer is aspirated into a 2-mL syringe and locally delivered in to the periodontal pocket

PROCEDURE

SRP+ciprofloxacine loaded iPRF

The concentration of the ciprofloxacin drug to be loaded in iPRF will be decided based on the study of Murugan et al., 2024. According to their study, 1 mg/mL of the drug concentration will be found to be biocompatible with maximum efficacy and showed a sustained release of 59% of the loaded drug at the end of the 14-day observation. 1 mg of the drug will be weighed and mixed with 100 μL of deionized water and shaken for 30 seconds to make the drug completely soluble, which will be done just before the blood collection from the participants. Then, 900 μL of the obtained i-PRF will be dispensed in a vial containing a 1-mg/100 μL solution of ciprofloxacin and shaken gently for 10 seconds to obtain a homogenous mix with a final concentration of 1 mg/mL. This mixture will further immediately loaded in a 1-mL insulin syringe and injected into the periodontal pocket until it filled the pocket

Sponsors & Collaborators

  • Suez Canal University

    lead OTHER

Principal Investigators

  • abdelnasser mohamed elrefaei, professor · professor of oral medicine and periodontology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-01-01
Primary Completion
2025-08-07
Completion
2025-08-07

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06968286 on ClinicalTrials.gov