Stability of Bimaxillary Proclination Cases Following Fixed Appliances Treatment: A Randomized Control Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 27
- 试验地点
- 2
- 主要终点
- Stability: Change in the incisal inclinations
研究概览
简要总结
Bimaxillary dental proclination is the condition where the upper and lower dental arches are procline thus increase lip fullness. Since the aim of orthodontic treatment in bimaxillary proclination in to get flatten profile where the incisor inclinations are purposely reduced or interincisal angle are increased, therefore it is guarded for corrected dentition to maintain stable or not post orthodontic treatment.Therefore, this study is looking into evidence which is the best retainer to maintain stability of bimaxillary proclination cases following fixed appliances treatment.
详细描述
Study title Stability of Bimaxillary Proclination Cases Following Fixed Appliances Treatment: A Randomized Control Trial
Study Population Pre-treatment of bimaxillary proclination patient who completed active orthodontic treatment with fixed appliances and are scheduled to debond at Orthodontic Clinic, Faculty of Dentistry, University of Malaya.
Study Design Randomized, prospective, single-center control trial. Three parallel arm groups of patients will be assigned for 3 types of retention methods; 1.VFR 2.Fixed bonded retainer 3.Double regime (bonded & VFR)
Aim of study To determine the best mode of retention to maintain the stability of bimaxillary proclination cases treated by four premolars extraction and fixed appliances.
Specific Objectives
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
The patient will be decided for the type of retention treatment by picking an opaque and sealed envelope.
The participants study models will be examined and assigned with a blinding code by first researcher , who will be blinded to the subjects' retainer allocation. Patients name on the printed radiograph will also be removed. Therefore,the first researcher will be blinded to those she will be measuring. The blinding code will be prepared by second researcher before first researcher measure the casts and radiographs.
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Pretreatment bimaxillary proclination patients with interincisal angle less than 125º (Keating PJ 1986).
- •Patients with fixed orthodontic appliances treatment on both arches consisting of the extraction of 4 premolars (Keating 1986).
- •Both arches are indicated for retainers.
- •Pre-treatment lateral cephalometric radiograph of adequate diagnostic quality.
排除标准
- •Pretreatment spacing eg: Median diastema.
- •No change or proclined lower labial segment post treatment.
- •Early debond patient.
- •Patient intended to relocate within study period.
- •Hypodontia that require prosthesis, cleft lip and/or cleft palate, or orthognathic cases.
- •Patients with learning disabilities and unable to listen, speak and read written instructions in Bahasa Melayu or English.
结局指标
主要结局
Stability: Change in the incisal inclinations
时间窗: 1 year post debond of orthodontic fixed appliances
To measure any changes in the upper incisor to maxillary plane angle, lower incisor to mandibular plane angle and changes in interincisal angle. This angular measurement will be measured in degree.
次要结局
- Stability: Soft tissue changes(1 year post debond of orthodontic fixed appliances)
- Stability of dentition(1 year post debond of orthodontic fixed appliances)
- Impact of retainers on Oral Health Related Quality of Life(1 year post debond of orthodontic fixed appliances)
- Changes in arches parameters(1 year post debond of orthodontic fixed appliances)
研究者
Norhidayah Mohd Tahir
Dr.Norhidayah bt Mohd Tahir, Lecturer
University of Malaya