Evaluation of Injectable PRF With Vitamin C as an Adjunct to Non-surgical Therapy in the Treatment of Stage II Grade A Periodontitis. A Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Bleeding on Probing (BOP)
研究概览
简要总结
Comparing the effect of using vitamin C with injectable PRF as a locally delivered adjunct to scaling and root planing versus scaling and root planing with local delivery of injectable PRF and scaling and root planing alone on the clinical parameters in Stage II Grade A Periodontitis patients.
详细描述
The conventional approach:
Group 1: Scaling and root planing alone using Gracey curettes and ultrasonic scalers.
Group 2: Scaling and root planing using Gracey curettes and ultrasonic scalers with local delivery of injectable PRF using an insulin syringe with the blunt needle inserted into the bottom of the periodontal pocket through a template to hold the locally delivered injectable PRF.
The intervention approach:
Scaling and root planing using Gracey curettes and ultrasonic scalers with local delivery of vitamin C (250 μM) and injectable PRF, using an insulin syringe with the blunt needle inserted into the bottom of the periodontal pocket through a template to hold the locally delivered vitamin C and injectable PRF for a longer time.
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)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with healthy systemic condition.
- •Adult patients ˃ 18 years old.
- •Patients with Stage II Grade A periodontitis.
- •Patients accept 6-months follow-up period (cooperative patients).
- •Patients provide an informed consent.
排除标准
- •Presence of prosthetic crowns.
- •Extensive restorations.
- •Periodontal therapy within the last 12 months.
- •Having surgical therapy or undergoing orthodontic treatment.
- •Ongoing drug therapy that might have an impact on the clinical signs and symptoms of periodontitis.
- •The use of antibiotics or anti-inflammatory drugs 1 month prior to the procedure and till the end of 6 months of follow-up.
- •Pregnant females.
结局指标
主要结局
Bleeding on Probing (BOP)
时间窗: 3 months
Gentle probing of the orifice of the gingival crevice. The periodontal probe will be inserted 1 to 2 mm into the gingival sulcus starting at one interproximal area and moving to the other. If bleeding occurs within 10 seconds a positive finding is recorded.
次要结局
- Probing Depth (PD)(6 months)
- Plaque Index (PI)(6 months)
- Gingival Marginal Level (GML)(6 months)
- Clinical Attachment Level (CAL)(6 months)
- Intraoral Radiographs(6 months)
- Post-Operative Pain(48 hours)
研究者
Mohamed Abdulhakim Mohamed Sherif
Principal investigator
Cairo University