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 | Completed DMC

• 2 other identifiers: Suez canal ethical committeeshaimaa Morsy
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

periodontitis; SRP; i-PRF; ciprofloxacine; IL-6

Outcome Measures

Primary Outcomes (1)

• change in the clinical attachment level, change in pocket depth

  recorded by periodontal probe at baseline, 1 month and 3 months postoperative follow-up interval

  baseline, 1 month and 3 months

Secondary Outcomes (1)

• detection of concentration of interleukin 6 after nonsurgical periodontal treatment combined with local delivery of iPRF or ciprofloxacine loaded PRF

  baseline, 1 month and 3 months

Study Arms (3)

SRP

ACTIVE COMPARATOR

prticipants with periodontitis will be treated with conventional periodontal therapy with non surgical scaling and root planning

Procedure: SRP

SRP+i-PRF

ACTIVE COMPARATOR

participants with periodontitis will be treated with nonsurgical periodontal therapy combined with local delivery of injectable platelet rich fibrin

Procedure: SRP+Injectable platelet rich fibrin

SRP+ciprofloxacine loaded i-PRF

ACTIVE COMPARATOR

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. Preparation of the Drug-loaded i-PRF 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. Local Delivery of Ciprofloxacin-loaded i-PRF This mixture will further immediately loaded in a 1-mL insulin syringe and injected into the periodontal pocket until it filled the pocket

Procedure: SRP+ciprofloxacine loaded iPRF

Interventions

SRP PROCEDURE

participants with periodontitis treated with scaling and root planning

SRP

SRP+Injectable platelet rich fibrin PROCEDURE

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

SRP+i-PRF

SRP+ciprofloxacine loaded iPRF PROCEDURE

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

SRP+ciprofloxacine loaded i-PRF

Eligibility Criteria

• Age: 30 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• The age range of thirty to forty-five
• The participants were diagnosed with stage II grade B periodontitis based on the 2018 classification.
• Participants who have at least two areas with a probing depth (PD) of ≤5 mm and have periodontal disease
• Clinical attachment loss (CAL) values of ≥2 mm or more in participants with periodontal disorders. (Elgendy et al ., 2015)

You may not qualify if:

• Pregnant and lactating women
• Use of immunosuppressive medications, consumption of antibiotics, and any antioxidants and anti-inflammatory agents in the last three months
• A history of periodontal therapy in the preceding one year
• Subjects with hemoglobin levels \< 11 mg/dL
• Subject participating in any other clinical trials
• Insulin-dependent diabetes

Sponsors & Collaborators

• Suez Canal University: lead

Study Sites (1)

Suez canal university

Ismailia, 12345, Egypt

Location

Related Links

• J Adv Periodontol Implant Dent. 2024 Sep 11;16(2):94-102. doi: 10.34172/japid.2024.021

MeSH Terms

Conditions

Periodontitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• abdelnasser mohamed elrefaei, professor

  professor of oral medicine and periodontology

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: This RCT will be blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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. Preparation of the Drug-loaded i-PRF 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. Local Delivery of Ciprofloxacin-loaded i-PRF This mixture will further immediately loaded in a 1-mL insulin syringe and injected into the periodontal pocket until it filled the pocket and overflows

Study Record Dates

• First Submitted: May 5, 2025
• First Posted: May 13, 2025
• Study Start: January 1, 2025
• Primary Completion: August 7, 2025
• Study Completion: August 7, 2025
• Last Updated: August 8, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)