Evaluation of the Effectiveness ff Elastic Chains Versus Elastics in Maxillary Canine Retraction: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Rate of maxillary canine retraction by elastics and elastic chains on each side
研究概览
简要总结
This clinical study aimed to evaluate the effectiveness of Elastics and Elastic chains in maxillary canine retraction. Participants of this study were patients undergoing maxillary canine retraction after first premolar extraction. The study aimed to determine an effective method for better controlling tooth movement.
This study was initiated on 01-2024. Initially, I was not aware of the importance of early registration on ClinicalTrials.gov. Registration was completed after the study began to ensure transparency and adherence to ethical guidelines. All study procedures and protocols have been conducted under the supervision of the academic advisor. All study procedures and protocols have been followed according to institutional and ethical guidelines
详细描述
This split-mouth Randomized clinical trial was conducted on 33 patients who needed maxillary canine retraction. Participants were randomly selected one side to receive an elastic chain and the other for elastics, as a method for canine retraction. The intervention period lasted for 15 weeks, and the elastics were replaced by the patient every three days, while elastic chains were exchanged by the principal investigator at 5-week appointments. The type of movement that occurred with each method was evaluated to measure the rate of tooth movement, tipping, and rotation resulting. The study was conducted under the supervision and approval of the Research Ethics Committee at Sana'a University, Faculty of Dentistry. All procedures were performed according to the approved protocol, ensuring participant safety and data accuracy.
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
- Single (Outcomes Assessor)
盲法说明
Due to the nature of the clinical intervention, neither the patients nor the investigator could be blinded to the treatment. However, researcher blinding was implemented at the data measurement stage through coding of OPG images and dental models by inter examiner, before measurements began. The researcher was blinded to patient identities and the type of retraction method used on each side (elastic chain vs. elastics).
入排标准
- 年龄范围
- 14 Years 至 25 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients' treatment required 1st premolar extractions in the maxillary arch and space closure involving canine retraction.
- •Teeth in the buccal segments were without any gross anatomic root anomalies as determined by panoramic radiographs.
- •There is no gross evidence of asymmetric bone loss in the buccal segments of a given arch as determined by panoramic radiographs.
- •Crown/root ratios of contralateral canines and premolars are within 3 mm of one another as determined by panoramic radiographs.
排除标准
- •Patients with gross anatomical anomalies in upper maxillary canines
- •Patients with growth and development problems.
- •Evidence of bone loss.
- •Presence of Impacted Canine.
- •History of long-term use of NSAIDs and corticosteroids or drugs affect bone metabolism. Patients who reported any medication interfering with bone metabolism or patients with severe skeletal discrepancies indicated for orthognathic treatment.
- •Patients with latex materials allergy.
研究组 & 干预措施
Elastic chains
This side received maxillary canine retraction using elastic chains
干预措施: Elastomeric chain (Procedure)
Elastics
This side received maxillary canine retraction with Elastics on the contralateral side of the arch
干预措施: Elastics (Procedure)
结局指标
主要结局
Rate of maxillary canine retraction by elastics and elastic chains on each side
时间窗: Difference between pe and post retraction canine position during 15 weeks
The canine retraction rate was measured on superimposed digital casts of pre and post retraction models.
Measurement of the Tipping movement occurred by each method
时间窗: Pre and post retraction during 15 weeks
Tipping angle on each side was measured on Orthopantomograms (OPG).
Measurements of rotation resulted by elastic and elastic chain
时间窗: Pre and post-retraction during 25 weeks
The rotational angle was measured on each side by the digital models
次要结局
未报告次要终点
研究者
Asraa Haleem Mohamed Tah
Resident in orthodontics
Sana'a University