Retentive Capacity of Bonded Retainer Versus Vacuum-formed and Combined Bonded-vacuum Retainers: A Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- The stability of the orthodontic treatment result and the degree of relapse from baseline to 6 months
研究概览
简要总结
The main goal is to test the differences between the retentive capacity of fixed retainer, vacuum-formed retainer & combination of both; and recommend the most effective protocol for retention of lower incisors crowding treated by non-extraction treatment plan
The main question is: In patients with lower incisors crowding treated by non-extraction treatment plans, what is the difference in retentive capacity between fixed retainer, vacuum formed retainer and combined bonded and vacuum retainers in maintaining corrected lower anterior segment crowding? After enrolment, each participant will have the orthodontic appliance debonded, the adhesive remnant removed and the enamel surface polished. An alginate impression will be taken to be poured into a study model which will be scanned to obtain STL files for digital models. All patients will have periodontal charting and probing depths recorded for the lower anterior segment. According to the randomization, each patient will be assigned to a group to receive the retainer. All patients will be called for follow-up after 1 week, 1 and 3 months.
详细描述
Research objective: Retention is a key part of success of orthodontic treatment. Unless we can maintain the teeth in position after orthodontic treatment, the beneficial results of the treatment can be lost. There are currently many different types, designs and materials of removable and fixed retainers and it is unclear which retainers are the best, and how long they should be used for. There is also little knowledge about the possible adverse effects on the Periodontal health, patients' satisfaction and compliance are better with which type of retainers; and which retainers have the greatest failure rate. The dual retention protocol -combined vacuum and fixed retainers- is widely used among clinicians but without strong evidence on its effectiveness compared to the use of single retainer.
Research procedure in brief:
This study will be carried out on patients enrolled from the Outpatient Clinic of Orthodontics department, Faculty of Dentistry, Cairo University.
Eligibility criteria:
Inclusion criteria:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult patients
- •Finished non-extraction orthodontic treatment
- •Full set of permanent dentition (excluding third molars).
- •Good oral hygiene
- •No restorations on lower anterior teeth or morphologic crown anomalies.
- •Little's irregularity index score 0
排除标准
- •Systemic disease or drugs affecting periodontal health.
- •Poor oral health that precludes orthodontic treatment (presence of caries, active white spots,or periodontal diseases)
结局指标
主要结局
The stability of the orthodontic treatment result and the degree of relapse from baseline to 6 months
时间窗: Relapse will be measured at 1 week, 1 month, 3 months and 6 months after the intervention during the follow-up period and will be done by a single calibrated examiner
The stability of the orthodontic treatment result and the degree of relapse will be measured by superimposition of the digital model at each time point on the initial model after debonding at T0.
次要结局
- Patient's satisfaction(It will be measured at 1 week, 1 month, 3 months and 6 months after the intervention during the follow-up period and will be done by a single calibrated examiner)
- Periodontal health(It will be measured at 1 week, 1 month, 3 months and 6 months after the intervention during the follow-up period and will be done by a single calibrated examiner)
- The integrity of the retainers(It will be measured at 1 week, 1 month, 3 months and 6 months after the intervention during the follow-up period and will be done by a single calibrated examiner)
- Patient's compliance(It will be measured at 1 week, 1 month, 3 months and 6 months after the intervention during the follow-up period and will be done by a single calibrated examiner)
研究者
Hadeer Ayman Ahmed El Behery
Master Degree student, Orthodontics department, Faculty of dentistry, Cairo University
Cairo University