Comparison of Periodontal Health, Bonding Time and Failure Between Direct and Indirect Fixed Retainer Placement Among Orthodontic Patients - A Modified Split-mouth Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Assessment of retainer failure
研究概览
简要总结
The placement technique of retainers in both maxillary and mandibular arches can influence the time taken for bonding the retainer in the mouth of a patient which can in turn affect the patient´s response to the procedure. The different placement techniques can influence the stability of the retainer wire on teeth and the maintenance of periodontal health during the retention period. Therefore, it is essential to know which technique is better suited for placement and its influence on periodontal health so that in the future it helps clinicians save their time during placement of retainers while benefiting the patients. To our knowledge, this will be the first study both locally and internationally that will include an assessment of periodontal health, time duration of placement and stability of fixed retainer in the maxillary arch as well. Three months period is sufficient for assessment of periodontal health and failure of retainer, long term studies can be at a risk of attrition bias.
OBJECTIVES:
The objectives of this study are:
- The primary objective of this study is to compare the failure of fixed retainers, along with periodontal health and bonding time, which are bonded either through direct method or indirect method on patients undergoing orthodontic debonding through a modified split-mouth technique using mean values for plaque index, gingival index, calculus index follow up appointments over a period of three months.
- The secondary objective of the study is to assess the amount of time taken during placement of retainers via both direct and indirect bonding of fixed retainers
详细描述
HYPOTHESIS:
- Null Hypothesis: There is no difference in placement technique of fixed retainers that can influence the failure of fixed retainers.
- Alternate Hypothesis: There is a 54% difference in placement technique of fixed retainers that can influence the failure of fixed retainers.
MATERIAL & METHODS:
Study Design: A modified split-mouth randomized controlled trial Settings: Department of Surgery, Dental clinics at the Aga Khan University Hospital.
Study Duration: Minimum six months after ethical review committee (ERC) approval, two months will be used for recruitment of participants in this study.
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
- None
入排标准
- 年龄范围
- 13 Years 至 40 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients aged between 18 - 40 years
- •Patients who read, write and understand English language
- •Patients undergoing fixed orthodontic treatment
- •Patients with good oral hygiene, with grade 1 or below on plaque and gingival indices at the time of debonding of brackets.
- •All patients who will sign the informed consent form
排除标准
- •Patients with periodontal disease
- •Patients with any systemic disease
- •Pregnant or nursing females
- •Patients who cannot come for follow up appointments for a retainer check up
结局指标
主要结局
Assessment of retainer failure
时间窗: 3 months with 3 follow ups, one at the time of placement and one at 1 month, next on 3rd month
using the frequency of breakage of retainer wire, we will assess retainer failure
次要结局
未报告次要终点
研究者
Rashna Hoshang Sukhia
Associate Professor
Aga Khan University Hospital, Pakistan