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: A Randomized Controlled Clinical Study
- Conditions
- Periodontitis Stage IINon Surgical Periodontal Treatment
- Registration Number
- NCT06968286
- Lead Sponsor
- Suez Canal University
- Brief Summary
sixty periodontally diseased patients will be enrolled in the study. After the patients will randomly devided into one of three treated groups, group 1 (n=20), SRP only; group 2 (n=20), SRP + i-PRF; group 3 (n=20), SRP+Cip loaded iPRF. 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.
- Detailed Description
The current randomized, controlled parallel-design study will be conducted at Suez Canal University's Oral Medicine and Periodontology Department following approval of the study design by the Institutional Review Board and Ethics Committee (931/2024).
Murugan et al. (2024) published a formula that will be used to determine the clinical trial's sample size. According to the following inclusion and exclusion criteria, the study population will be chosen from the subjects who visited the outpatient section of the Department of Oral Medicine and Periodontology Department, Suez Canal University, ion, the sample size was 20 in each group.
Inclusion Criteria
1. The age range of thirty to forty-five
2. The participants will be diagnosed with Stage II Grade B periodontitis based on the 2018 classification.
3. Participants who have at least two areas with a probing depth (PD) of ≤5 mm and have periodontal disease
4. Clinical attachment loss (CAL) values of ≥2 mm or more in participants with periodontal disorders. ( Elgendy et al ., 2015)
Exclusion Criteria
1. Female who are pregnant or nursing
2. During the past three months, use of immunosuppressive drugs, antibiotics, antioxidants, and anti-inflammatory medicines
3. A history of periodontal treatment throughout the previous 12 months.
4. Individual taking part in more clinical trials
Randomization
A computer-generated randomization list utilizing RANDOM.ORG software (www.random.org) with a 1:1 allocation ratio will be used to allocate patients at random to the SRP (control), SRP+ I-PRF, or SRP+CIP loaded I-PRF groups. A non-recruiting faculty member (RA) issued each participant a number, which will then hidden in opaque, sealed envelopes. When adjuctive therapy will be applied, the sealed envelope will be opened to disclose the allocated treatment, and the number will be chosen by the RA for concealment.
Blinding Because it will be unavoidable for the participants and the physician performing the nonsurgical procedure (SH) to be blinded to the interventions, this RCT will be blinded, with the statistician and outcome assessors (MA) blinded.
Patient grouping:
According to the treatment procedure, all 60 selected patients will be randomly allocated to one of the three groups:
Group 1 (n=20): This group will be treated only with SRP without any adjunct therapy.
Group 2 (n=20) After SRP, this group will be treated with the delivery of drug-free i-PRF into the periodontal pocket and gingival tissue adjacent to the pocket. The i-PRF will be applied only once and will be repeated during the study period.
Group 3 (n=20): Ciprofloxacin-loaded i-PRF will be administered to this group's periodontal pocket and gingival tissue next to the pocket wall following SRP. Throughout the course of the study, the i-PRF will be used just once.
Preparation of ciprofloxacin solution
Based on the research of Murugan et al., 2024, the ciprofloxacin medication concentration to be loaded in i-PRF will be determined. After a 14-day observation period, their study found that a medication concentration of 1 mg/mL will be biocompatible, have the highest efficacy, and demonstrate a sustained release of 59% of the loaded drug. Just before the participants' blood being drawn, one milligram of the medication will be weighed, combined with 100 μL of deionized water, and shaken for 30 seconds to make the drug fully soluble.
Collection of i-PRF
The i-PRF will be prepared by the same operator using the procedure developed by Miron and Choukron in 2017. This protocol involves obtaining 10 mL of intravenous blood by venipuncturing the participant's antecubital vein under sterile conditions. Immediately after collection, the blood will be centrifuged in a sterile, simple test tube without an anticoagulant for three minutes at 700 rpm and 70 g force. The blood splits into two layers after centrifugation: the top layer is composed of platelet-rich fibrin plasma, which is still liquid, and the bottom layer is composed of a compartment for red blood cells. The top layer of platelet-rich fibrin will be aspirated using a 2-mL syringe and then locally administered into the periodontal pocket for group II.
Preparation of ciprofloxacin-loaded i-PRF
To create a homogeneous mixture with a final concentration of 1 mg/mL, PRF will then be distributed in a vial containing a 1-mg/100 μL solution of ciprofloxacin and gently shaken for 10 seconds. (Murugan1 \& Jayakumar 2023)
Local Delivery of Ciprofloxacin-loaded i-PRF
Before it turns into a gel in the group III participants, this combination will also be placed right away into a 1-mL insulin syringe and injected into the periodontal pocket until it fills the pocket and overflows into the tissue next to the periodontal pocket. As previously mentioned, plain i-PRF will be administered to group II participants at the experimental sites. All study participants received postoperative instructions. None of the subjects had a prescription for mouthwash or any other medications, and they will be asked to return for follow-up after one or three weeks.
Clinical assessment
The clinical parameters of the target sites will be measured using a William's probe (Dentsplay, USA) at baseline, 3 months, and six months after the treatment. The periodontal parameters included plaque index (PI), (Silness \& Loe 1964), gingival index (GI), pocket depth (PD) (Ramfjord 1967) assessed from the gingival margin to the base of the pocket, and clinical attachment level (CAL) assessed from the cementoenamel junction (CEJ) to the base of the pocket.
Collection of GCF for IL6 detection
GCF samples will be collected from one area from a tooth showing PPD ≤ 5 mm with the highest clinical signs of both inflammation will be selected for GCF sampling. Supragingival plaque will be removed using a sterile curette without touching the gingival margins, and the area will be gently dried. Cotton rollers were then used to isolate the area in order to avoid contaminating it with saliva. Filter paper (Periopaper, Proflow; Amityville, NY, USA) was used to collect GCF. After carefully inserting paper strips into the gingival sulcus until they encountered only slight resistance, they were left there for 30 seconds. Blood- and saliva-contaminated strips were thrown away. Following the measurement of the GCF volume of each strip using precalibrated electronic impedance equipment (Periotron 8000, ProFlow; Amityville, NY, USA), the strips will be promptly placed into sterile polypropylene tubes and kept at -80°C until analysis.
Each filter paper strip's GCF will be eluted into PBS in the following manner: samples will be kept at 4°C for two hours before the IL-6 tests. After each strip was raised to the eluent's surface, 350 μL of PBS was added, for a total final volume of 600 μL. The samples were then centrifuged for 10 minutes at 10,000 rpm and chilled for an additional 20 minutes at 4°C. The strips will be eventually thrown away.
IL-6 will be analyzed using commercial ELISA kits (R and D systems, Abingdon, Oxon, UK). A quantitative "sandwich" enzyme immunoassay method is used in the kit. A 96-well microplate will be precoated with an antihuman monoclonal antibody specific to IL-6. In the presence of IL-6, the immobilized antibody bound it. Each well received 200 μL of an enzyme-linked (horseradish peroxidase) polyclonal antibody specific for IL-6 (goat antihuman) following the washing of unattached proteins.
200 μL of a substrate solution will then be added, and the amount of IL-6 that will be bound in the first stage was shown by the color that appeared. Using a microplate reader set to 450 nm with wavelength correction set to 540 nm, the color intensity (optical density) will be determined in 30 minutes. By plotting the concentration of the IL-6 standards (2000, 1000, 500, 250, 125, 62.5, 31.2, and 0 pg/mL) against their optical density, a standard curve was created, and the IL-6 concentration was ascertained. The IL-6 concentration (pg/mL) was then calculated by dividing the amount of IL-6 by the GCF volume (μL), and the pg of IL-6 in each sample (total amount) was computed. The ELISA assays will be performed twice, and the concentrations and total quantities of the cytokine will be determined using the mean values.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 60
Not provided
1 - Pregnant and lactating women 2. Use of immunosuppressive medications, consumption of antibiotics, and any antioxidants and anti-inflammatory agents in the last three months 3. A history of periodontal therapy in the preceding one year 4. Subjects with hemoglobin levels < 11 mg/dL 5. Subject participating in any other clinical trials
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method gain in the clinical attachment level, decrease in pocket depth baseline, 1 month and 3 months recorded by periodontal probe at baseline, 1 month and 3 months postoperative follow-up interval
- Secondary Outcome Measures
Name Time Method 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 GCF will be collected at (baseline, 1 months and 3 months postoperatively) using periopaper strip (Oraflow, NY, USA). Prior to collection of GCF, the teeth will be isolated by cotton rolls. Then, gentle water and air spray will be used to eliminate blood and saliva from the test and control teeth. Using periopaper strip, GCF will be collected at the mesial and distal sites of the study and control teeth. The periopaper strip will be inserted into the sulcus until resistance will be felt and remained there for 30 seconds. In case of contamination with blood or saliva, it will be discarded and the procedure will be repeated. After collection of GCF, periopaper strip will be sealed in sterile polypropylene containers and stored at -80 °C until ELISA.
Trial Locations
- Locations (1)
Suez canal university
🇪🇬Ismailia, Egypt