COMPARISON OF EFFICACY OF HAWLEY VERSUS VACUUM FORMED RETAINERS IN RELATION TO STABILITY OF TREATMENT, PERIODONTAL HEALTH, COMPLIANCE AND COMFORT: A RANDOMISED CLINICAL TRIAL
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- To find out which retainer out of the two (Hawley v/s vacuum formed retainer) is better in terms of stability of intercanine width, intermolar width,alingment,arch length and periodontal health in each group and their comparison
研究概览
简要总结
AIM**-** : Comparison of efficacy of Hawley versus vacuum formed retainers in relation to stability of treatment, periodontal health, oral health related quality of life, patient compliance and comfort.
OBJECTIVES**-**
Primary objective:
1. Comparison of efficacy of Hawley v/s vacuum formed retainers in relation to the stability and maintenance of treatment results.
2. Comparison of efficacy of Hawley v/s vacuum formed retainers in relation to maintenance of periodontal health.
Secondary Objective:
1. To compare oral health related quality of life in patients wearing Hawley v/s vacuum formed retainers.
2. To compare the compliance and comfort of patients with Hawley v/s vacuum formed retainers.
| Objective |
Outcomes
Method of measurement
|1.
To compare efficacy of Hawley v/s vacuum formed retainers in relation to the maintenance and stability of treatment results
To see whether treatment results are maintained to a similar extent with both type of retainers
· Little’s irregularity index
· Intercanine, intermolar width assessment
· Arch length
|2.
To Compare efficacy of Hawley v/s vacuum formed retainers in relation to maintenance of periodontal health.
To see whether the periodontal health is maintained better with one type of retainer in comparison to another
· Gingival index
· Plaque index
· Calculus index
|3.
To compare oral health related quality of life of patients wearing Hawley v/s vacuum formed retainers.
To check the patient’s perception with both type of retainers in terms of OHRQoL.
· OHIP-14 questionnaire
|4.
To compare the compliance and comfort of patients with Hawley v/s vacuum formed retainers.
To see which retainer is more comfortable and better accepted by the patients.
· Questionnaire
Null Hypothesis
The null hypothesis of the present study is that there is no difference between Hawley and vacuum formed retainers in relation to stability of treatment results, maintaining periodontal health, OHRQoL of patients and both retainer types are equally comfortable without any difference in patients’ compliance in regard to wearability by patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 25.00 Year(s)（—）
- 性别
- All
入选标准
- •North Indian healthy young adult subjects with18-25 years of age.
- •Patients with completed fixed orthodontic treatment within past 7 days of enrolment.
- •Literate subjects with good understanding of English and Hindi language.
- •Subjects with the willingness to participate in the study.
排除标准
- •Subjects with altered mental status, cognitive disorders and craniofacial anomalies (cleft lip and palate and other syndromes).
- •Patients with the habit of smoking/ chewing tobacco, alcohol abuse etc.
- •Subjects refusing to participate in the study.
结局指标
主要结局
To find out which retainer out of the two (Hawley v/s vacuum formed retainer) is better in terms of stability of intercanine width, intermolar width,alingment,arch length and periodontal health in each group and their comparison
时间窗: T0- baseline (0-7days after debonding) | T1- 1 month after baseline | T2- 3 months after baseline | T3- 6 months after baseline
次要结局
- To find out which retainer out of the two (Hawley v/s vacuum formed retainer) is better in terms of better tolerance by patients and is better at providing good oral health related quality of life in patients.(T0- baseline (0-7days after debonding))
研究者
Dr Kritika Chauhan
JN Kapoor DAV (C) Dental college and hospital