Evaluation of Osteogenic Potential of Cissus Quadrangularis on Mandibular Alveolar Ridge Distraction
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Relapse after distraction
研究概览
简要总结
Deficient alveolar mandibular ridge corrected distraction osteogenesis to facilitate dental implant placement. Patients grouped into 2 groups: one group received Cissus quadrangularis during the consolidation period, and the other group received placebo.
详细描述
OPGs were taken immediately after distractor placement, at end of activation period, at 1st,2nd month of consolidation period, and at end of consolidation period. Change in bone height was evaluated immediately after distractor placement, at end of activation and end of consolidation periods.
CBCT were taken immediately after implant installation, and 6 months later to evaluate change bone density and marginal bone level about the dental implant.
histological evaluation was done by biopsy obtained, by trephine bur, from implant site during its preparation. The bone biopsy fixed in 4% formalin solution for 7 days, rinsed in water, and dehydrated in sequent phases of ethanol (70, 80, 90, and 100%) and then specimens were stained by hematoxylin- eosin for microscopic evaluation.
Radiographic evaluation
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, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients were included if they were free from any disease that may affect healing. Also, presented with 2-3 missing teeth at least in posterior area and CBCT showed bone height above inferior alveolar canal (IAC) ranged 8-10mm.
排除标准
- •patients were excluded if they suffered from any disease affect tissue healing, bad oral hygiene or heavy smoking patients
研究组 & 干预措施
Group 1
Placebo was given to ten patients during consolidation period ( 2 capsule daily for 6 months during consolidation period)
干预措施: Cissus Quadrangularis (Drug)
Group 2
Cissus quadrangularis in form of capsules given to ten patients ( 2 capsule daily for 6 months during consolidation period)
干预措施: Cissus Quadrangularis (Drug)
结局指标
主要结局
Relapse after distraction
时间窗: 3 months from beginning of consolidation period
Relapse evaluated on panorama
Bone gain after distraction
时间窗: immediately at end of distractor activation
Increase in bone height after distraction
Crestal bone loss around dental implant
时间窗: 6 months from implant placement
By using cone beam CT, crestal bone level around implant evaluated by measuring a distance from implant apex to a point on dental implant where bone contacts the dental implant mesially and distally. then average of bone loss round each implant was obtained.
Bone density around dental implant
时间窗: 6 months from implant placement
By using cone beam CT, bone density assessed around dental implant at crestal, middle, and apical portions then average was obtained
次要结局
未报告次要终点
研究者
Alaa Altaweel
Principle Investigator
Al-Azhar University