Efficacy and Cost-effectiveness of Orthodontic Retention Protocols
试验速览
- 阶段
- 不适用
- 入组人数
- 152
- 试验地点
- 2
- 主要终点
- severity of relapse (unexpected tooth movement in mandibular frontal area) at 2 years
研究概览
简要总结
Objective is to assess changes of dentition and periodontium, and hygiene in retention after the end of the active phase of orthodontic treatment, and relationship with gender, type of retention appliance, pre-therapeutic condition of dentition and duration of active phase of treatment.
详细描述
A total of 152 subjects will be recruited and randomly assigned into three groups. First group will have a square 8-stranded 0.673x0.268 mm retainer wire bonded in mandibular teeth after completing the active phase of comprehensive orthodontic treatment with fixed appliances. Retainer will be bonded on lingual site canine to canine on each tooth. Second group will have a round 6-stranded 0.40 mm retainer in mandible. Third group will be without fixed retainer, only with thermoplastic vacuum-formed removable Essix retainer in mandible.
Subjects will be examined before orthodontic treatment (T0), upon completion of treatment (T1), six months in retention (T2), two years (T3) and three years in retention (T4). Changes in intercanine width, relapse (unexpected tooth movements), retainer failure, accumulation of biofilm, calculus and gingivitis will be assessed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 11 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •finished orthodontic treatment, participants must have all permanent teeth
排除标准
- •hypodontia, missing teeth
结局指标
主要结局
severity of relapse (unexpected tooth movement in mandibular frontal area) at 2 years
时间窗: 2 years
the unabbreviated scale title: Little Irregularity Index (used to measure the crowding)- numerical rating scale in millimeters the minimum and maximum values: 0,10 higher scores mean a worse outcome lower scores mean a better outcome
severity of relapse (unexpected tooth movement in mandibular frontal area) at 3 years
时间窗: 3 years
the unabbreviated scale title: Little Irregularity Index (used to measure the crowding)- numerical rating scale in millimeters the minimum and maximum values: 0,10 higher scores mean a worse outcome lower scores mean a better outcome
incidence of retainer failure (debonding, breakage) at 3 years
时间窗: 3 years
percentage of cases with at least one fixed retainer failure, the minimum and maximum values 0%,100% higher scores mean a worse outcome, lower scores mean a better result
severity of relapse (unexpected tooth movement in mandibular frontal area) at 1 year
时间窗: 1 year
the unabbreviated scale title: Little Irregularity Index (used to measure the crowding)- numerical rating scale in millimeters the minimum and maximum values: 0,10 higher scores mean a worse outcome lower scores mean a better outcome
extent of biofilm accumulation at 3 years
时间窗: 3 years
the unabbreviated scale title: Silness and Loe Plaque Index-ratio of measuring sites in mandibular central sextant; the minimum and maximum values 0%,100%, higher scores mean a worse outcome, lower scores mean a better result
incidence of retainer failure (debonding, breakage) at 2 years
时间窗: 2 years
percentage of cases with at least one fixed retainer failure, the minimum and maximum values 0%,100% higher scores mean a worse outcome, lower scores mean a better result
extent of biofilm accumulation at 2 years
时间窗: 2 years
the unabbreviated scale title: Silness and Loe Plaque Index-ratio of measuring sites in mandibular central sextant; the minimum and maximum values 0%,100%, higher scores mean a worse outcome, lower scores mean a better result
次要结局
- incidence of intercanine width change(3 years)
- extent of calculus accumulation at 2 years(2 years)
- extent of calculus accumulation at 3 years(3 years)
- changes of intercanine width(2 years, 3 years)
研究者
silvija kanižaj ugrin
Dentist, Orthodontic specialist
Poliklinika Orthonova