Sticky Bone and Repeated Injectable PRF Application in Management of Periodontal Intrabony Defects (Randomized Clinical Trial)
试验速览
- 阶段
- 4 期
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- change in clinical attachment level
研究概览
简要总结
One of the main objectives of periodontal therapy is the regeneration of the tooth's supporting periodontal tissue to its original levels. The healing after non-surgical and conventional surgical methods is histologically characterized by a long junctional epithelium along the root surfaces. Therefore, reconstructive techniques are required. Although complete periodontal regeneration is unpredictable with any regenerative therapy currently used, so the objective of our trial is to get complete periodontal regeneration by using Sticky Bone and Repeated Injectable PRF (iPRF) in Management of Periodontal Intrabony Defects.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 48 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •No systemic diseases which could influence the outcome of therapy.
- •Good compliance with plaque control instructions following initial therapy.
- •Teeth involved were all vital with no mobility.
- •Each subject contributed a single predominately 2 or 3-wall intrabony interproximal defect around premolar or molar teeth without furcation involvement
- •Selected intrabony defects (IBD) measured from the alveolar crest to the defect base in diagnostic periapical radiographs of ≥ 3 mm, the width of ≥ 3 mm at its most coronal part, with no cratering that involve both mesial and distal surfaces of adjacent teeth.
- •Selected probing depth (PD) ≥ 6 mm and clinical attachment loss (CAL) ≥ 4 mm at the site of intraosseous defects four weeks following initial cause-related therapy.
- •Availability for the follow-up and maintenance program; 8) absence of periodontal treatment during the previous year.
排除标准
- •Pregnant females.
研究组 & 干预措施
Sticky Bone and Repeated Injectable PRF (iPRF)
The surgical treatment phase was initiated only if the subjects had a full-mouth dental plaque score of less than one and a test site plaque score of 0. Following mucoperiosteal flap reflection for one tooth on either side of the defect, all granulation tissue was removed from the defects by means of Gracey 7/8 metal curettes, and root surfaces were scaled and planed using hand and ultrasonic instruments, then the defect was filled with xenograft mixed with IPRF, Finally, the flap was replaced and closed with crossed horizontal and vertical internal mattress sutures.
干预措施: Sticky Bone and Repeated Injectable PRF (iPRF) (Biological)
bone substitute
The surgical treatment phase was initiated only if the subjects had a full-mouth dental plaque score of less than one and a test site plaque score of 0. Following mucoperiosteal flap reflection for one tooth on either side of the defect, all granulation tissue was removed from the defects by means of Gracey 7/8 metal curettes, and root surfaces were scaled and planed using hand and ultrasonic instruments, bone graft substitute was heavily condensed into the intra bony defects. The flap was replaced and closed with crossed horizontal and vertical internal mattress sutures.
干预措施: bone substitute (Biological)
结局指标
主要结局
change in clinical attachment level
时间窗: baseline, 3, and 6 months
change in clinical attachment level
次要结局
- change in interseptal bone width(baseline, 3, and 6 months)
研究者
mahmoud eldestawy
associate professor
Al-Azhar University