Efficiency of micro-osteoperforation assisted orthodontics on the rate of canine retraction: a split mouth randomized controlled clinical trial.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Mean rate of canine retraction per month, until 2 mm or less space is present distal to canine. Measured intraorally using a digital calipers. Measured as: residual extraction space between lateral incisor (disto-gingival wing of the bracket) and canine (mesio-gingival wing of the bracket); in mm; then expressed as [(space T0-space T1)/time T0-to-T1] in mm/month. Measured by: a calibrated person, fully blinded to experimental/control side (an orthodontist).
研究概览
简要总结
This study is an in vivo, interventional, surgical, single-center, split-mouth randomized, controlled clinical trial evaluating the efficiency of micro-osteoperforations in enhancing the rate of canine retraction and its effects on various dental and bony structures.
The primary outcome measure will be the mean rate of canine retraction per month, which will be measured intraorally.
The hypotheses are:
-
There is no difference in the rate of micro-osteoperforation assisted and conventional canine retraction.
-
There is no difference in the amount of anchorage loss, cumulative canine displacement, root resorption, alveolar bone loss, bone density and discomfort level between micro-osteoperforation and conventional canine retraction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 12.00 Year(s) 至 32.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients undergoing fixed mechanotherapy with upper first premolar extractions requiring 5 mm or more of maxillary canine retraction.
- •Presence of full complement of teeth except third molars.
- •Fair oral hygiene.
排除标准
- •Patients presenting with:
- •Previous history of orthodontic treatment.
- •Medical or systemic problems.
- •Active caries, pulpitis or periodontal disease.
- •Severe crowding (≥6mm) or severe cant of the maxillary skeletal base or palatal plane (inclination angle ≤ 80 and ≥ 95 degrees and base plane angle ≤20 and ≥40 degrees) simultaneously existing with severely divergent or convergent facial planes (Bjork sum <385 and >400).
- •Patients exhibiting microdontia or less than 5 mm of space available for canine retraction.
结局指标
主要结局
Mean rate of canine retraction per month, until 2 mm or less space is present distal to canine. Measured intraorally using a digital calipers. Measured as: residual extraction space between lateral incisor (disto-gingival wing of the bracket) and canine (mesio-gingival wing of the bracket); in mm; then expressed as [(space T0-space T1)/time T0-to-T1] in mm/month. Measured by: a calibrated person, fully blinded to experimental/control side (an orthodontist).
时间窗: Measurement timing: at baseline (before space closure), at 1-month intervals; end at space closure finalization (2 mm or less space remaining distal to the canine).
次要结局
- •Cumulative canine distal movement measured in mm, on pre and post dental casts.(• Canine and molar rotation, tip, root resorption,bone density in HU, and alveolar bone loss to be measured on CBCT scans.)