"A Comparative Evaluation of Injectable Platelet-Rich Fibrin (i-PRF) With and Without Amoxicillin in the Treatment of Chronic Periodontitis: A Randomized Controlled Trial"
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- To evaluate the efficacy of amoxicillin incorporated I-PRF as local drug delivery for the treatment.
研究概览
简要总结
To achieve the desirable accomplishments, there we are attempting to evaluate the clinical efficacy of injectable Platelet-Rich Fibrin (i-PRF) with and without amoxicillin as an adjunct to scaling and root planing (SRP) in the management of chronic periodontitis. A total of eligible participants will be randomly allocated into two groups: the test group will receive SRP followed by subgingival injection of amoxicillin-loaded i-PRF, while the control group will receive SRP followed by injection of drug-free i-PRF. i-PRF is prepared from autologous blood using a low-speed centrifugation protocol and injected into periodontal pockets more than 5 mm and adjacent interdental papillae in a single treatment session. The study aims to assess and compare clinical periodontal parameters such as probing pocket depth (PPD), clinical attachment level (CAL), bleeding on probing (BOP), and plaque index (PI) at baseline and subsequent follow-ups. The objective is to determine whether the addition of amoxicillin to i-PRF enhances periodontal healing outcomes compared to i-PRF alone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 25.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patient diagnosed with chronic periodontitis o Patients having periodontal pockets of more than 5 mm
- •Patient with clinical attachment loss more than 2 mm 3.Age group between 25- 50 years.
- •Patients with good general health, without any history of systemic disease or under medication
- •Patient ready to give written informed consent.
排除标准
- •Medically compromised patient.
- •o Patient on antimicrobial therapy
- •Smokers and smokeless tobacco users.
- •Patients showing unacceptable oral hygiene during evaluation.
- •Patient who received periodontal therapy in the past 6 months.
- •5.Pregnant women and lactating mothers.
结局指标
主要结局
To evaluate the efficacy of amoxicillin incorporated I-PRF as local drug delivery for the treatment.
时间窗: At base line, 1month, 3month
次要结局
- I.Assessment of gingival index and plaque index before and after placement of amoxicillin incorporated I-PRF as local drug delivery.(II.Assessment of periodontal pocket depth (PPD) and clinical attachment index (CAL) before and after index before and after placement of amoxicillin incorporate I-PRF .)
研究者
Priyanka Yadav
faculty of dental sciences IMS, BHU