Department of Pediatric Dentistry and Orthodontics, Federal University of Rio de Janeiro- UFRJ, Rio de Janeiro, Brazil; Department of Health I, Southwest Bahia State University, Jequié, Bahia, Brazil.
Department of Pediatric Dentistry and Orthodontics, Federal University of Rio de Janeiro- UFRJ, Rio de Janeiro, Brazil.
Am J Orthod Dentofacial Orthop. 2019 Sep;156(3):303-311. doi: 10.1016/j.ajodo.2019.04.022.
One of the goals of malocclusion treatment is to improve the oral health-related quality of life (OHRQoL) of patients. The aim of this trial was to assess the OHRQoL of children before, during, and after anterior open bite (AOB) correction, compared with nontreated children, in a 2-arm parallel single-blind randomized controlled trial.
Eighty children with AOB aged 8-10 years were randomly assigned to 2 groups (n = 40 each): a group treated with the use of fixed palatal crib (FPC; TG) and a control group (nontreated; CG). Randomization was performed with the use of BioEstat software. The outcome (OHRQoL) was assessed with the use of the validated Brazilian Portuguese version of the Child Perceptions Questionnaire (CPQ) applied before (baseline, phase 1), 3 months after FPC placement (phase 2), and 1 month after FPC removal (phase 3) in the TG. In the CG, CPQ was applied at baseline (phase 1), 3 months (phase 2), and 12 months (phase 3). Data were analyzed by means of a blinded statistic with the use of Friedman, Wilcoxon, and Mann-Whitney tests (α = 0.05).
All participants finished the RCT, and demographic characteristics were similar between groups. In phase 1, the TG had lower scores for the "social well-being" domain (P = 0.02). In phase 2, the CG had higher scores than the TG for the "emotional well-being" and "social well-being" domains, but the opposite was observed for "oral symptoms" and "functional limitations" (P < 0.001). In phase 3, the TG showed a lower impact on OHRQoL than the CG in all domains and in the overall score (P < 0.001). In the 3 phases, the CG showed progressive increase (mean scores 70.37, 74.70, and 84.22, respectively; P < 0.001) and the TG a decrease (mean scores 70.20, 70.80, and 6.05, respectively; P < 0.001) in overall scores. The increase of scores in the CG was considered to represent a serious harm.
Correction of AOB had a positive impact and failure to correct it had a negative impact on the OHRQoL of children.
This trial was not registered.
The protocol was not published before trial commencement.
错颌畸形治疗的目标之一是改善患者的口腔健康相关生活质量（OHRQoL）。本试验旨在通过一项双臂平行单盲随机对照试验，比较安氏 I 类前牙开𬌗（AOB）矫正前后儿童的 OHRQoL，与未经治疗的儿童进行比较。
80 名 8-10 岁患有 AOB 的儿童被随机分为两组（每组 40 名）：使用固定腭托（FPC）治疗组（TG）和对照组（未治疗；CG）。随机分组使用 BioEstat 软件进行。使用经过验证的巴西葡萄牙语版儿童感知问卷（CPQ）评估结果（OHRQoL），在 TG 中分别于治疗前（基线，第 1 阶段）、FPC 放置后 3 个月（第 2 阶段）和 FPC 去除后 1 个月（第 3 阶段）进行评估。在 CG 中，CPQ 分别于基线（第 1 阶段）、3 个月（第 2 阶段）和 12 个月（第 3 阶段）进行评估。使用盲法统计分析数据，采用 Friedman、Wilcoxon 和 Mann-Whitney 检验（α=0.05）。
所有参与者均完成了 RCT，且两组的人口统计学特征相似。在第 1 阶段，TG 在“社会幸福感”维度的得分较低（P=0.02）。在第 2 阶段，CG 在“情感幸福感”和“社会幸福感”维度的得分高于 TG，但在“口腔症状”和“功能障碍”方面则相反（P<0.001）。在第 3 阶段，TG 在所有维度和总分上的 OHRQoL 影响均低于 CG（P<0.001）。在第 3 阶段，CG 显示出逐渐增加（平均得分分别为 70.37、74.70 和 84.22，P<0.001），而 TG 则呈下降趋势（平均得分分别为 70.20、70.80 和 6.05，P<0.001）。CG 分数的增加被认为是严重的伤害。
AOB 的矫正有积极影响，而不矫正则对儿童的 OHRQoL 有负面影响。
本试验未注册。
试验开始前未公布方案。
