Comparative Evaluation of Demineralised Freeze-Dried Bone Allograft with and without Spirulina Gel in the treatment of Class II Furcation Defects: A Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- To evaluate and compare the effectiveness of DFDBA with and without Spirulina gel in the treatment of Class II Furcation defects clinically and radiographically by CBCT.
研究概览
简要总结
This study will include patients visiting the department of Periodontics and Implantology diagnosed with Stage III Periodontitis and exhibiting Class II furcation defects. Two sites in each patient will be assigned randomly for sampling.
It will be conducted in Department of Periodontics and Implantology, after taking informed consent from the patient. All the clinical and radiographical parameters will be evaluated at baseline after which the sites in the patients will be randomly and equally divided into Test and Control groups to be treated with Spirulina gel with DFDBA and DFDBA alone respectively in Class II furcation defects in Stage III Periodontiits patients. The study will be initiated after clearance from the Institutional Ethics Committee. For each patient two sites will be randomly assigned as;
Group I: (Control Group) – Stage IIIPeriodontitis exhibiting bilateral Class II furcation defects to be treated with DFDBA alone.
Group II: (Test Group) - Stage IIIPeriodontitis exhibiting bilateral Class II furcation defects to be treated with DFDBA with Spirulina gel.
Pre-surgical Hygiene
Therapy Initial therapy will consist of detailed oral hygiene instructions and Scaling and root planing. Prior to initiating the study, its purpose and design will be explained and written informed consent will be signed by every patient.
Surgical procedure: Under local anaesthesia, full thickness mucoperiosteal flaps will be reflected and granulation tissue will be debrided. The root surfaces will be scaled and planed. In Group I the Class II furcation defects will be treated with DFDBA alone while in Group II the Class II furcation defects will be treated using DFDBA with Spirulina gel. The flaps will be sutured back to their original position. Periodontal dressing will be placed at the surgical sites.
Post-surgical Care: Patient will be placed on antibiotics and analgesics. Sutures will be removed after 7 days. Clinical results will be evaluated at 3 and 6 months post-operatively and radiographic evaluation will be performed at 6 months post-operatively by CBCT.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 30.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients with stage III Periodontitis as assessed by Probing Pocket Depth (PPD) more than or equal to 6mm ,interdental clinical attachment level (CAL) more than or equal to 5 mm and Horizontal Probing Depth (HPD) more than or equal 2mm.
- •Bilateral buccal or lingual Class II furcation involvement.
排除标准
- •1.Patients with history of systemic diseases, allergies or drug usage.
- •2.Patients who have undergone periodontal treatment in previous 6 months.
- •3.Pregnant and lactating females.
- •4.Smokers or tobacco chewers.
结局指标
主要结局
To evaluate and compare the effectiveness of DFDBA with and without Spirulina gel in the treatment of Class II Furcation defects clinically and radiographically by CBCT.
时间窗: at baseline,3 months and 6 months
次要结局
- 1. Assess clinical parameters (CAL, PPD, HPD) in Class II furcation defects treated with Spirulina gel + DFDBA and DFDBA alone.(2. Evaluate radiographic bone fill using CBCT in defects treated with Spirulina gel + DFDBA and DFDBA alone.)
研究者
Dr Tasneem Azad
Ranjeet Deshmukh Dental College and Research Center