Evaluation of the Effects of Osteoperforation and Piezocorticision on Canine Retraction: Randomized Controlled Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 17
- 试验地点
- 2
- 主要终点
- Rate of canine retraction
研究概览
简要总结
The primary objective of this research is to compare the rate of canine retraction following the osteoperforation and piezocorticision procedures in cases of first premolar extractions. The secondary objectives are to compare the second order movement of the canine (tipping), the amount of root resorption associated with the procedures, the inflammation process by measuring the inflammatory markers in the gingival crevicular fluid, the loss of posterior anchorage by measures on the cone beam computed tomography (CBCT) 3-dimensional radiograph and on the casts and to evaluate the pain level and the impact on quality of life following each procedure using the questionnaire of the visual analogue scale (VAS) of pain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Dental and/or skeletal Cl I and II requiring maxillary first premolar extraction.
- •Young adults 16 years and older.
- •Good overall health.
- •Complete adult dentition.
- •Cooperative.
- •Acceptable hygiene.
- •Absence of any periodontal disease (gingivitis, periodontitis).
排除标准
- •Non-cooperative, fearful patients or patients with intellectual disability.
- •Patients requiring the regular use of nonsteroidal anti-inflammatory drugs (NSAID).
- •Use of antibiotics in the last 6 months.
- •Previous or current use of bisphosphonates, corticosteroids or immunosuppressive drugs.
- •Patients suffering from uncontrolled systemic diseases (ex. diabetes type I and II).
- •Presence of oral or maxillofacial malformations (ex. cleft palate) or dental pathologies (ex. ankylosis, abscess).
结局指标
主要结局
Rate of canine retraction
时间窗: From the time of force application until the distal of the canine touches the mesial of the second premolar. We estimate the time frame to be up to 24 weeks. Measures will be taken at two week intervals.
The speed at which the canine is moved in the space of the extracted premolar.
次要结局
- Level of pain(Daily, for 7 days following extraction of premolars and piezocorticision and osteoperforation procedures)
- Concentration of IL-1 in the gingival fluid sample(Measures are taken immediately before the periodontal procedures, then at 1,3,8 weeks and when the distal of the canine touches the mesial surface of the second premolar which can take up to 24 weeks.)
- Amount of tipping(The measure is taken when the distal of the canine touches the mesial of the second premolar. We estimate the time frame to be up to 24 weeks)
- Amount of root resorption(The measure is taken when the distal of the canine touches the mesial of the second premolar. We estimate the time frame to be up to 24 weeks)
- Amount of posterior loss of anchorage(The measure is taken when the distal of the canine touches the mesial of the second premolar. We estimate the time frame to be up to 24 weeks)
- Concentration of osteoprotegerin (OPG) in the gingival fluid sample(Measures are taken immediately before the periodontal procedures, then at 1,3,8 weeks and when the distal of the canine touches the mesial surface of the second premolar which can take up to 24 weeks.)
- Concentration of receptor activator of nuclear factor kappa-B ligand (RANKL) in the gingival fluid sample(Measures are taken immediately before the periodontal procedures, then at 1,3,8 weeks and when the distal of the canine touches the mesial surface of the second premolar which can take up to 24 weeks.)
研究者
Le George Dinh-Khang
Principal investigator
Université de Montréal