Evaluating the efficacy of metronidazole-loaded TPRF in open flap debridement for periodontitis management: a randomized controlled trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
研究概览
简要总结
The aim of this randomized clinical trial is to compare the clinical efficacy of metronidazole-loaded Titanium-Prepared Platelet-Rich Fibrin (T-PRF) and T-PRF alone as adjuncts to open flap debridement (OFD) in the surgical management of periodontal pockets. After obtaining informed consent and recording a comprehensive case history, 30 patients with moderate to severe generalized periodontitis will be enrolled and randomly allocated into two groups: a test group treated with OFD + metronidazole-loaded T-PRF and a control group treated with OFD + T-PRF alone. Following phase I periodontal therapy, patients will be clinically re-evaluated to confirm suitability for surgery. Randomization will be performed using computer-generated tables, and outcome assessment will be single-blinded to minimize bias.
All surgical procedures will be performed by a single operator using a standardized OFD protocol. Metronidazole-infused T-PRF and T-PRF membranes will be prepared from autologous blood using titanium tubes and placed into the periodontal defects following thorough debridement. Clinical parameters including Plaque Index (PI), Gingival Index (GI), Probing Pocket Depth (PPD), and Relative Clinical Attachment Level (RCAL) will be recorded at baseline, 3 months, and 6 months postoperatively to evaluate treatment outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Investigator Blinded
入排标准
- 年龄范围
- 30.00 Year(s) 至 65.00 Year(s)(—)
- 性别
- All
入选标准
- •Patients exhibiting atleast two periodontal pockets with a probing pocket depth of or more than 5mm and clinical attachment loss (CAL) of or more than 4mm in any two quadrants.
- •No history of intake of antibiotics or other medications affecting the periodontium in preceding 6 months.
- •Patient willing for surgery and ready to give written consent.
排除标准
- •Systemic illness or diagnosis of heart condition that would require prophylactic antibiotic cover.
- •Smokers, pregnant or lactating patients will be excluded.
- •Patient with any known allergy to any kind of medication.
- •Platelet count less than 1.5 platelets per microliter.
- •Patient with bleeding disorder, anti platelet or anti coagulant therapy.
研究者
Dr Sakshi Vidhale
SMBT Dental College and Hospital
