To compare occlusal settling and patient compliance between two differently designed vaccum formed retainer -A randomized controlled clinical study.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Change in occlusal contacts and change in patient compliance
研究概览
简要总结
Minimum 72 subjects will be included in this study.
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Group 1: 36 subjects in Essix Retainer group
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Group 2: 36 subjects in Modified Essix Retainer retainer group.
· Randomization: For randomization participants will be randomly allocated to both groups.
Subjects who have completed their orthodontic treatment will be included in this study. Essix Retainer will be constructed as per the design. Modified Essix Retainer will be constructed as per the design. All the retainers will be made by single person. Lingual fixed retainers will be bonded in lower arch . The patients will be instructed to wear the retainers 24 hours a day for 6 months, excluding while eating and brushing their teeth. All necessary instructions about wear and maintenance will be given. All participants will be recalled to take records at following time intervals:
(1) At retainer Delivery [T0]
(2) At 3 months[T1]
(3) At 6 months[T2]
Maxillary alginate impressions and a vinyl polysiloxane bite will be registered each time. Occlusal contacts will be measured on registered bite. Occlusal contacts will be classified as : -
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True contacts : Points where material is perforated.
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Near contacts : Translucent points where the thickness less than 0.20mm.
Both types of contacts will be considered. Patient compliance will be assessed by Questionnaire at 3 months and 6 months of retainer delivery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients who give consent for the proposed study
- •Patients who have undergone fixed orthodontic treatment.
- •Patients who have completed their orthodontic treatment and are in retention phase of treatment.
- •Patients who are systemically healthy.
排除标准
- •1.Patients having craniofacial or Dentofacial Syndromes.
- •Patients treated for anterior open bite.
- •Patients suffering from diabetes.
- •Patients who are suffering from periodontal disorder.
- •Non-compliant patients.
结局指标
主要结局
Change in occlusal contacts and change in patient compliance
时间窗: At Time of retainer Delivery, 3 months of retention and 6 months of retention
次要结局
未报告次要终点