Periodontal Changes and Gingival Soft Tissue Healing Following Mid Maxillary Distraction in Cleft Lip and Palate Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Measurement of periodontal inflammatory mediators
研究概览
简要总结
To evaluate the health status of the periodontium and dentition at the distraction osteogenesis site in CLP subjects using mid maxillary distraction (MMD).
详细描述
Segmental forward maxillary distraction osteogenesis(DO)was performed. Distractor connecting buccal molar segments to the anterior maxilla was kept for 7 days. Then distraction was performed till overcorrection and consolidated for 3-months. Periodontal clinical parameters were recorded at baseline, 3 and 6-months postoperatively. Gingival crevicular fluid was collected . Soft tissue healing was evaluated clinically and histologically after distraction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
The clinical assessment was not masked , however, the histological and biomarker examination were send to blind investigator not directly involved in the study
入排标准
- 年龄范围
- 16 Years 至 25 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Severe maxillary hypoplasia and negative anterior overjet
排除标准
- •Systemic disease
研究组 & 干预措施
Study
A Involvement with the osteotomy site of the surgery, osteotomy was performed then GCF were collected from teeth neighboring the
干预措施: A Involvement with the osteotomy site of the surgery (Procedure)
Control
Involvement with the osteotomy site of the surgery, surgical osteotomy was performed then GCF were collected from teeth away from the osteotomy site
干预措施: A Involvement with the osteotomy site of the surgery (Procedure)
结局指标
主要结局
Measurement of periodontal inflammatory mediators
时间窗: 7 days
periodontal inflammatory mediators IL-1β
次要结局
- Assessment of clinical attachment loss(3 and 6 month)
- Measurement of periodontal inflammatory mediators TNF- α(7 days)
- Assessment of periodontal probing depth(3 and 6 month)
- Assessment of periodontal clinical parameters(3 and 6 month)
研究者
Marwa Ibrahim Madi
Principle investigator
University of Alexandria