Clinical Effectiveness of Bonded Versus Vacuum-formed Retainers After 12 Months: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Changes in Little Irregularity Index (LII)
研究概览
简要总结
The purpose of the study was to compare the clinical effectiveness of bonded versus vacuum-formed retainers regarding their retention capacity; periodontal health; survival rates; and patients' perception after 12 months of removal of fixed appliances.
The null hypotheses considered that there was no differences between the retainers in relation to the aspects evaluated.
详细描述
This single-center randomized controlled trial was performed at the Department of Orthodontics, Bauru Dental School, University of São Paulo, Brazil.
A total of 50 patients completing orthodontic treatment were recruited. The patients were prospectively and randomly allocated into two groups. The first group consisted of 25 patients with canine-to-canine V-bend bonded retainers; while the second group comprised 25 patients with vacuum-formed retainers. In both groups, the same retainers were installed in the maxillary and mandibular arches.
Patients were evaluated at deboning (T0), after 3 months (T1), 6 months (T2), and 12 months (T3). In each appointment, digital models were obtained and the other clinical variables were evaluated. The primary and secondary outcomes were compared between retainers in the time-points evaluated.
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
- Single (Outcomes Assessor)
盲法说明
Masking of the principal investigator and participants was not be possible due to the nature of the interventions. Nonetheless, the outcome assessor was blinded for the periodontal and patient perception variables.
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with the proper completion of orthodontic treatment and correction of the initial malocclusion.
- •Acceptable oral hygiene (assessed through clinical examination).
- •Presence of all teeth up to the second molars.
- •Clinically acceptable teeth alignment.
排除标准
- •Patients with any systemic condition that may have an influence on periodontal health.
- •Patients with facial deformities.
- •Initial malocclusion that required extreme corrections, large transverse expansions or orthognathic surgery.
- •History of periodontal diseases.
研究组 & 干预措施
Vacuum-formed Retainer
The removable Vacuum-formed retainers were made of acetate 1mm thickness. They were made at the same appointment of debonding using plaster models. The patients were instructed to use the retainers only during nights.
干预措施: Vacuum-formed Retainer (Device)
V-bend Bonded Retainer
The V-bend retainer was bonded in the lingual surface of the anterior teeth. The retainer was constructed using 0.024" stainless steel wires. Differently from the conventional bonded retainers, this retainer presents V-bends in the sagittal direction, parallel to the occlusal plane in each interproximal contact point of the incisors and canines.
The retainers was bonded after adequate etching with phosphoric acid and application of adhesive with a low viscosity resin.
干预措施: V-bend Bonded Retainer (Device)
结局指标
主要结局
Changes in Little Irregularity Index (LII)
时间窗: Changes were compared at T0 (Debonding); T1 (3 Months Follow-up); T2 (6 Months Follow-up); and T3 (12 Months Follow-up).
Stability was evaluated comparing the changes in the Little Irregularity Index (LII) between time-points. The average of the linear distances between the anatomical contact points of the anterior teeth were considered.
次要结局
- Intercanine Distance(Evaluation was performed at T0 (Debonding); T1 (3 Months Follow-up); T2 (6 Months Follow-up); and T3 (12 Months Follow-up).)
- Intermolar Distance(Evaluation was performed at T0 (Debonding); T1 (3 Months Follow-up); T2 (6 Months Follow-up); and T3 (12 Months Follow-up).)
- Overjet(Evaluation was performed at T0 (Debonding); T1 (3 Months Follow-up); T2 (6 Months Follow-up); and T3 (12 Months Follow-up).)
- Gingival Health(Evaluation was performed at T0 (Debonding); T1 (3 Months Follow-up); T2 (6 Months Follow-up); and T3 (12 Months Follow-up).)
- Plaque Accumulation(Evaluation was performed at T0 (Debonding); T1 (3 Months Follow-up); T2 (6 Months Follow-up); and T3 (12 Months Follow-up).)
- Retainers Survival Rates(Evaluation was performed during the 12 Months of follow-up.)
- Overbite(Evaluation was performed at T0 (Debonding); T1 (3 Months Follow-up); T2 (6 Months Follow-up); and T3 (12 Months Follow-up).)
- Calculus Accumulation(Evaluation was performed at T0 (Debonding); T1 (3 Months Follow-up); T2 (6 Months Follow-up); and T3 (12 Months Follow-up).)
- Patients' Perception(Evaluation was performed at T0 (Debonding); T1 (3 Months Follow-up); T2 (6 Months Follow-up); and T3 (12 Months Follow-up).)
研究者
Silvio Augusto Bellini-Pereira
Principal Investigator
University of Sao Paulo