Comparative Clinical and Radiographic Evaluation of the Effect of Decalcified Freeze Dried Bone Allograft (DFDBA) with Amniotic Membrane and Decalcified Freeze Dried Bone Allograft (DFDBA) with Platelet Rich Fibrin (PRF) as Membrane in the Treatment of Intrabony Defects in Chronic Periodontitis Patients
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- 1. Plaque Index (P.I.) (SILNESS AND LOE, 1964)
研究概览
简要总结
The aim of the study is to evaluate and compare clinically and radiographically the Effect Of Decalcified Freeze Dried Bone Allograft (DFDBA) with Amniotic Membrane and Decalcified Freeze Dried Bone Allograft (DFDBA) with Platelet Rich Fibrin (PRF) as Membrane in the Treatment of Intrabony Defects in Chronic Periodontitis Patients. A total of 40 patients with Chronic Periodontitis will be selected from out patient department of Periodontology, Nair Hospital Dental College, Mumbai and will be equally divided into two groups of 20 each. In group A, Decalcified Freeze Dried Bone Allograft (DFDBA) with Amniotic Membrane will be placed and in Group B, Decalcified Freeze Dried Bone Allograft (DFDBA) with Platelet Rich Fibrin (PRF) as Membrane will be placed in interproximal bone defects. The study is interventional prospective study. Computer generated randomization method will be used as sampling method. The duration of study is 20 months which includes a duration of 14 months for treatment procedure and 6 months for follow up. The primary efficacy parameters are plaque index, gingival index, probing pocket depth and clinical attachment level. Plaque and gingival index will be recorded at baseline, 1 month, 3 months and 6 months post surgery. Probing pocket depth and clinical attachment level will be recorded at baseline, 3 months and 6 months post surgery. Radiographic analysis of the surgical site will be done to measure bone fill at baseline, immediately post surgery and 6 months post surgery. The data will be analysed individually for all the patients. The values will be subjected to comparison within and between the groups using Paired and Unpaired Student T-Test. There is no conflict of interest.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 20.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •.Age group between 20-60years 2).Diagnosis with chronic periodontitis 3).Patients in good systemic health with no contraindication to periodontal surgery 4).Patients having Intrabony defects with pocket depths of >5mm and with radiographic evidence of vertical / angular bone loss in the affected sites.
- •.Involved teeth to be vital and asymptomatic.
排除标准
- •.One — wall osseous defects.
- •.Patients suffering from any systemic diseases or with compromised immune system.
- •.Patients who had received any type of periodontal therapy for the past 6 months 4).Patients taking any immuno-suppressive drugs like corticosteroids 5).Patients with a known history of allergy to doxycycline or Chlorhexidine or any other medicine are used in the study.
- •.Patients showing unacceptable oral hygiene compliance during / after the phase I therapy.
- •.Patients taking any drug known to cause gingival enlargement.
- •.Pregnant and/or lactating mothers.
- •.Patients who were smokers or had tobacco in any other form.
- •.Endodontically treated teeth.
- •.Patient on anticoagulant therapy 12).Patient with bleeding disorders.
结局指标
主要结局
1. Plaque Index (P.I.) (SILNESS AND LOE, 1964)
时间窗: clinical evaluation at baseline, 1 month, 3 months and 6 months after surgery. | Radiographic evaluation at baseline, immediate post surgery and 6 months post surgery.
3. Probing Pocket Depth (PPD).
时间窗: clinical evaluation at baseline, 1 month, 3 months and 6 months after surgery. | Radiographic evaluation at baseline, immediate post surgery and 6 months post surgery.
4. Clinical Attachment Level (CAL).
时间窗: clinical evaluation at baseline, 1 month, 3 months and 6 months after surgery. | Radiographic evaluation at baseline, immediate post surgery and 6 months post surgery.
5.Radiographic Bone fill will be evaluated using intra oral periapical radiograph of the surgical site.
时间窗: clinical evaluation at baseline, 1 month, 3 months and 6 months after surgery. | Radiographic evaluation at baseline, immediate post surgery and 6 months post surgery.
2. Gingival Index (G.I.) (LOE &SILNESS, 1963).
时间窗: clinical evaluation at baseline, 1 month, 3 months and 6 months after surgery. | Radiographic evaluation at baseline, immediate post surgery and 6 months post surgery.
次要结局
- 1. Plaque Index (P.I.) (SILNESS AND LOE, 1964)(2. Gingival Index (G.I.) (LOE &SILNESS, 1963).)