Effect of Different Grafting Material Following Surgically Facilitated Orthodontics Therapy: a Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Change in horizontal bone thickness at the 3mm point from Cementoenamel junction (CEJ) (crestal level) on the mandibular incisors
研究概览
简要总结
The purpose of this study is to quantitatively investigate the radiographic changes of alveolar bone, and gingival tissue changes of the mandibular anterior teeth in experimental group A receiving SFOT using freeze-dried allograft with a collagen membrane, experimental group B receiving SFOT using particulate xenograft covered by a collagen membrane and control group receiving only orthodontics therapy.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •American Society of Anesthesiologists (ASA) I/II
- •Periodontal diagnosis of clinical gingival health or gingivitis on intact/reduced periodontium per 2017 American Academy of Periodontology (AAP) classification
- •No history of periodontitis.
- •Class I malocclusion
- •Crowding of 4 mm or less on mandibular anterior incisors
- •Incisor mandibular plane angle between 90-100 degrees
- •No extractions indicated as part of the orthodontic treatment plan
- •Keratinized tissue of at least 3mm
排除标准
- •Patients who are current smokers
- •Pregnancy
- •Uncontrolled diabetes or other metabolic systemic conditions
- •Presence of open bite or deep bite
- •Excessive retroclined mandibular incisors
- •Any contraindication to treatment or the material used if in the experimental groups
结局指标
主要结局
Change in horizontal bone thickness at the 3mm point from Cementoenamel junction (CEJ) (crestal level) on the mandibular incisors
时间窗: from baseline to endpoint (Alignment visit, approximately 4 months after the start of orthodontics treatment)
Change in horizontal bone thickness at the 6mm point from CEJ (middle level) on the mandibular incisors
时间窗: from baseline to endpoint (Alignment visit, approximately 4 months after the start of orthodontics treatment)
Change in horizontal bone thickness at the 9mm point from CEJ (apical level) on the mandibular incisors
时间窗: from baseline to endpoint (Alignment visit, approximately 4 months after the start of orthodontics treatment)
Change in volume of three dimensional bone
时间窗: from baseline to endpoint (Alignment visit, approximately 4 months after the start of orthodontics treatment)
Change in volume of three dimensional soft tissue
时间窗: from baseline to endpoint (Alignment visit, approximately 4 months after the start of orthodontics treatment)
次要结局
- Change in vertical bone level (VBL)from the CEJ(Baseline, at alignment (approximately 4 months after the start of orthodontics treatment).)
- Change in probing depth (PD)(Baseline, at alignment (approximately 4 months after the start of orthodontics treatment).)
- Change in clinical attachment level (CAL)(Baseline, at alignment (approximately 4 months after the start of orthodontics treatment).)
- Change in width of keratinized tissue (WKT) at alignment(Baseline, at alignment (approximately 4 months after the start of orthodontics treatment).)
研究者
Sahar Dowlatshahi
Assistant Professor
The University of Texas Health Science Center, Houston