Evaluation of Advanced Platelet-rich Fibrin in Management of Periodontal Intrabony Defects
试验速览
- 阶段
- 不适用
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- Clinical attachment level change
研究概览
简要总结
The aim of this study is to clinically and radiographically evaluate the efficacy of advanced platelet-rich fibrin (A-PRF) when used with biphasic alloplast in the management of intrabony defects in patients with moderate to severe chronic periodontitis.
详细描述
Biphasic alloplasts have been successfully used in management of intrabony defects. Advanced platelet-rich fibrin is believed to contain higher amount of growth factors and white blood cells than the well known PRF. Although there are some studies on the use of PRF in the treatment of intrabony defects, to date none of them evaluate the effect of the A-PRF. Therefore, a randomized controlled clinical trial was conducted to compare the healing of intrabony defects treated with A-PRF/biphasic alloplast combination and to those obtained with biphasic alloplast mixed with saline. Using a parallel arm design, 22 intrabony defects were randomly treated with either biphasic alloplast mixed with saline (control group) or with A-PRF/ biphasic alloplast combination (test group). The following clinical parameters were recorded at baseline, three and six months postoperatively : plaque index (PI), modified gingival index (MGI), probing depth (PD), clinical attachment level (CAL), while these radiographic measurements were recorded at baseline and six months postoperatively: bone fill and bone density.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •They should be diagnosed as having moderate -severe chronic periodontitis according to the American Academy of Periodontology classification on gingival and periodontal diseases (1999)
- •Clinical attachment loss (CAL) ,radiographic evidence of the presence of at least one intrabony defect.
- •Patient's age between 25 to 55 years.
- •Both sexes.
- •No periodontal surgeries in the area of interest during the previous 6 months.
- •The presence of intrabony defects (IBD) ≥3 mm deep (distance between alveolar crest and deepest point in the defect estimated from radiographs and confirmed upon surgical exposure).
- •An interproximal probing depth (PD) ≥5 mm and clinical attachment loss (CAL) ≥3mm after phase I therapy in maxillary/ mandibular teeth.
- •The presence of an adequate zone of keratinized gingiva at the facial aspect of the selected tooth.
排除标准
- •Patients who could not maintain O'leary plaque index (54) ≤10% after phase I therapy.
- •Aggressive periodontitis patients.
- •Patients with systemic conditions known to affect the periodontal status, or, under medications known to affect the outcomes of periodontal therapy.
- •Pregnancy/lactation.
- •Smoking and tobacco use in any form.
- •Non vital teeth and teeth with grade III mobility.
研究组 & 干预措施
group I (Test)
Advanced platelet-rich fibrin mixed with biphasic alloplast
干预措施: Advanced platelet-rich fibrin mixed with biphasic alloplast (Procedure)
Group II (control)
Biphasic alloplast mixed with saline
干预措施: Biphasic alloplast mixed with saline (Procedure)
结局指标
主要结局
Clinical attachment level change
时间窗: Baseline , 3 and 6 months posoperatively
The distance from cemento-enamel junction to the depth of the sulcus recorded by a periodontal probe at baseline , 3 and 6 months postoperatively
次要结局
- Radiographic bone density(Baseline and 6 months postoperatively)
- Radiographic bone fill(Baseline and 6 months postoperatively)
- Probing depth change:(Baseline , 3 and 6 months postoperatively)
研究者
Jaylane kadry Ghonima
Instructor Jaylane Kadry Ghonima
Alexandria University