A Single-center, 3-arm, Parallel-group Randomized Controlled Trial to Evaluate Bond Failures and the Effectiveness of Three Orthodontic Retention Schemes in Preventing Post-treatment Mandibular Arch Changes
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 发起方
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Breakage of fixed retainer wires
研究概览
简要总结
There is high possibility of relapse of the lower anterior teeth after orthodontic treatment. Relapse is related with the initial orthodontic anomaly, pathology of surrounding tissues, patient's age and sex and compliance and the retention protocol applied. The options for the later are various. Permanent fixed retainers are considered of the most common ones and vastly vary based of composition. There are fixed retainers distinguished for their composition (SS, β-NiTi, fiber-reinforced composite retainers) or for their shape and dimensions (round or rectangular shape and single-strand or multi-strand respectively), and/or for the teeth they are placed on (canine and canine or canine to canine). Fixed retainers may require patient's cooperation , nevertheless debond failure rate varies between 0.1-53%.
The aim of this prospective randomized clinical study is to compare failure incidents and retention effect on lower anterior teeth after orthodontic finish between three different types of fixed retainers. There will be 3 arms studied in this research: a) single strand 0.016x0.022'' β-Ti canine to canine, b) 0.028'' SS canine to canine and c) 0.027'' multi-strand twistflex canine to canine. Variables such as repeatability of failures, and undesired tooth movements will be measured. Measurements will be repeated every 3 months after patient's recruitment in this study, for one year period (12 months in total). Intraoral scans will be collected during baseline (fixed retainer insertion) and after 12 months.
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, Investigator)
入排标准
- 年龄范围
- 13 Years 至 30 Years(Child, Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients treated with fixed orthodontic appliances (Roth 0.018'' slot at their final finishing stage)
- •Patients with fixed orthodontic appliances at least between their lower first premolars
- •No lower anterior teeth crowding (total irregularity index score = 0)
- •Patients with no need of removable retention appliances on their lower teeth
排除标准
- •Active caries on adjacent or lingual surfaces of lower anterior teeth
- •Active periodontitis
- •Supragingival calculus
- •Gum bleeding during bonding of fixed retainer
- •Gingival pocket depth greater than 3mm
- •Syndromes or other anomalies of the craniofacial complex or other mental illness
- •Missing or impacted teeth or other dental anomalies
- •Congenital anomalies/syndromes
- •Allergies regarding the alloys of fixed retainers
- •Need for chemoprevention before data collection of periodontal indexes
- •Usage of antibiotics
- •Pregnancy
- •Participation in other clinical trials
结局指标
主要结局
Breakage of fixed retainer wires
时间窗: 9 months-1 year
Repeatability of bonding strength failure per patient and per tooth
时间窗: 9months-1 year
Number of teeth that failed regarding the bonding strength
时间窗: 9 months-1 year
Space discrepancy (Little index)(in mm)
时间窗: 9 months-1 year
Mandibular intercanine distance
时间窗: 6 months-9 months
Mandibular arch length (in mm)
时间窗: 9 months-1 year
次要结局
- Tooth rotations in lower anterior teeth(9 months-1 year)
- Extrusion in lower anterior teeth(9 months-1 year)
- Tip inclinations anteroposteriorly(9 months -1 year)
研究者
Iosif Sifakakis
Associate Professor
University of Athens
