Autologous Dentine Graft Compared to Xenograft in Managing Periodontally Compromised Second Molar After Third Molar Removal - A Split-Mouth Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Clinical Assessment
研究概览
简要总结
The goal of this study is to evaluate the efficacy of autologous dentin graft (ADG) in treating periodontal defects on the distal aspect of mandibular 2nd molar (M2) after surgical removal of impacted mandibular 3rd molar (M3) by improving periodontal and radiological outcomes when compared with a xenograft, which is commercially available. The main questions it aims to answer are:
- How does the clinical efficacy of ADG compare to xenografts, regarding wound healing and periodontal parameters at the distal aspect of periodontally compromised mandibular M2 following impacted M3 extraction?
- How does the radiological bone regeneration at ADG-grafted sites differ from that at xenograft-grafted sites?
- How do the post-operative patient-reported outcomes at sites receiving ADG differ from those at sites receiving xenografts?
Researchers will compare ADG to xenograft to see if ADG is more efficacious in managing periodontal defects on distal aspect of M2 after surgical removal of M3.
Participants will
- Undergo bilateral surgical removal of M3 under general anaesthesia
- Receive ADG on test site and xenograft on contralateral control site
- Come back for clinical assessments, wound healing assessments and radiographic assessments for 5 times after the surgery (2 weeks, 1 month, 3 months, 6 months and 12 months)
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 26 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients aged 26 years and above who can give informed consent and are scheduled for bilateral surgical removal of mesioangular or horizontally impacted mandibular M3s
- •Present with a periodontally compromised mandibular second molar, defined by the presence of probing pocket depth (PPD) greater than 4 mm on the distal aspect
- •Type of impaction of M3s on both sides must be symmetrical
- •Consent to the use of xenograft as control
排除标准
- •Poor oral hygiene with >30% full mouth plaque score (FMPS)
- •Pregnant or lactating mothers
- •Have uncontrolled systemic conditions such as diabetes or immunodeficiency disorders
- •On medications that affect bone metabolism, including bisphosphonates or corticosteroids
- •History of periodontal surgery or grafting at the intended surgical site
- •Presence of acute infection and M2s with distal caries and Grade III mobility
研究组 & 干预措施
ADG Group
ADG will be immediately packed into the extraction socket against the distal root of M2 until cementoenamel junction (CEJ) level, before flap repositioning and suturing.
干预措施: Autologous dentin graft (Biological)
Xenograft Group
Xenograft will be placed using the same placement technique as that employed in the ADG group.
干预措施: Xenograft (Biological)
结局指标
主要结局
Clinical Assessment
时间窗: Baseline, 3 months, 6 months, 12 months
Probing pocket depth (PPD) (mm)
Radiographic Assessment
时间窗: Baseline, 6 months, 12 months
Osseous defect depth (ODD)
次要结局
- Wound Healing Assessment(Baseline, 2 weeks, 1 month, 3 months, 6 months and 12 months)
- Patient Reported Outcome Measures(Baseline, Day 1, Day 3, 1 week, 2 weeks, 1 month)
研究者
Nik Madihah Nik Aziz
Lecturer and Clinical Specialist in Periodontology
National University of Malaysia