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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- change in the clinical attachment level, change in pocket depth
研究概览
简要总结
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).
详细描述
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.
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 was then hidden in opaque, sealed envelopes. When adjunctive 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
This RCT will be blinded
入排标准
- 年龄范围
- 30 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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)
排除标准
- •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
研究组 & 干预措施
SRP
prticipants with periodontitis will be treated with conventional periodontal therapy with non surgical scaling and root planning
干预措施: SRP (Procedure)
SRP+i-PRF
participants with periodontitis will be treated with nonsurgical periodontal therapy combined with local delivery of injectable platelet rich fibrin
干预措施: SRP+Injectable platelet rich fibrin (Procedure)
SRP+ciprofloxacine loaded i-PRF
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
干预措施: SRP+ciprofloxacine loaded iPRF (Procedure)
结局指标
主要结局
change in the clinical attachment level, change in pocket depth
时间窗: baseline, 1 month and 3 months
recorded by periodontal probe at baseline, 1 month and 3 months postoperative follow-up interval
次要结局
- 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)