"Comparison of Retention Characteristics of Immediate vs Delayed Retainer Delivery Using 3 Dimensional Digital Model Analysis : A Prospective Clinical Trial "
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- overbite
研究概览
简要总结
Retention has been defined as "the holding of teeth following orthodontic treatment in the treated position for the period of time necessary for the maintenance of the result". Controversies regarding retention regime exist due to lack of high quality evidence regarding duration, type and timing of different type retainer.The present randomised controlled trial will be undertaken to assess the changes and compare if there is any difference in movement of teeth in post orthodontic treatment cases with immediate and delayed (post 7 days) delivery using beggs retainer and change in level of bone biomarker over 6 months period of retention .
详细描述
The proposed study will be a prospective, non-pharmacological, single blind, randomized clinical trial to evaluate if there is a difference in transverse (X-axis), A-P(Y-axis) and Vertical plane(Z-axis) of dentition in two group of post orthodontic treatment patients with immediate retainer delivery(Beggs wrap around retainer ) in one group and post 7 days retainer delivery( beggs wrap around retainer) in other group of patients. The present study will be conducted in the Department of Orthodontic and Dentofacial Orthopedics, P.G.I.D.S, Pt. B.D Sharma University of health sciences, Rohtak. The study will be carried out after the institutional approval obtained from ethical committee.
A sample size of 18 patients was calculated keeping confidence interval 95% with power 80%. Accounting for a 10% drop out rate, 20 patients will be enrolled in each group. Patient will be randomly allocated to the study group by a person not involved in the trial using computer generated randomization list. Changes in the tooth movement in transverse(X-axis), A-P(Y-axis), Vertical plane(Z-axis) will be compared in terms of intercanine width, intermolar width, overjet, overbite and contact point displacement between the two groups at following time intervals. These parameters will be charted at T0, T1, T2,T3 and T4 for each patient.Changes in the tooth movement in transverse(X-axis), A-P(Y-axis), Vertical plane(Z-axis) will be compared in terms of intercanine width, intermolar width, overjet, overbite and contact point displacement between the two groups at following time intervals. These parameters will be charted at T0, T1, T2,T3 and T4 for each patient. T0 - Baseline records, at the time of debonding. T1 - Records obtained at the time of retainer delivery. T2 - Records obtained after 1 month of retainer delivery. T3 - Records obtained after 3 months of retainer delivery. T4 - Records obtained after 6 months of retainer delivery
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects who required extraction.
- •Optimal functional occlusion at end of treatment (PAR score >70%).
- •Littles irregularity index (Pre-treatment <6mm in both upper and lower arch).
- •Nonsurgical and non-orthopedic patients.
- •Non syndromic patients and no impaction of teeth except third molars.
- •Optimal periodontal condition and Good oral hygiene (probing depth <3mm, gingival index score <1
- •Good compliance regarding retainer wear.
排除标准
- •Subjects with incomplete orthodontic treatment.
- •TMJ disorder patients.
- •Any systemic disease affecting bone and general growth.
- •Patients with incomplete records.
- •Patient who fail to follow up or undergo complete treatment.
- •Patient with learning difficulties
- •Patients having antibiotic therapy within previous 3 months and used anti inflammatory drugs in the month before the study
研究组 & 干预措施
control group
beggs wrap around Retainer will be given to the patients immediately [Just after debonding].
干预措施: immediate orthodontic retainer delivery (Other)
experimental group
beggs wrap around Retainer will be delivered to the patients 7 days post debonding.
干预措施: delayed orthodontic retainer delivery (Other)
结局指标
主要结局
overbite
时间窗: T3 - 6 month after debonding
vertical overlap of upper and lower incisors
overjet
时间窗: T2 - 1 month after debonding
sagittal distance between upper and lower incisors
Overjet
时间窗: T3 - 6 month after debonding
sagittal distance between upper and lower incisors
contact point displacement
时间窗: T3 - 6 month after debonding
displacement of contact points in anterior teeth
intermolar width
时间窗: T3 - 6 month after debonding
transverse distance between the first molars
intercanine width
时间窗: T3 - 6 month after debonding
transverse distance between the canine
次要结局
- GCF - elisa(T2 - 1 month after debonding)