DiBiase Andrew T, Woodhouse Neil R, Papageorgiou Spyridon N, Johnson Nicola, Slipper Carmel, Grant James, Alsaleh Maryam, Cobourne Martyn T
Consultant, Department of Orthodontics, William Harvey Hospital, East Kent Hospitals University NHS Foundation Trust, Ashford, United Kingdom.
Postgraduate student, Department of Orthodontics, King's College London Dental Institute, London, United Kingdom.
Am J Orthod Dentofacial Orthop. 2016 Dec;150(6):918-927. doi: 10.1016/j.ajodo.2016.06.025.
A multicenter parallel 3-arm randomized clinical trial was carried out in 1 university and 2 district hospitals in the United Kingdom to investigate the effect of supplemental vibrational force on orthodontically induced inflammatory root resorption (OIIRR) during the alignment phase of fixed appliance therapy.
Eighty-one subjects less than 20 years old with mandibular incisor irregularity undergoing extraction-based fixed-appliance treatment were randomly allocated to supplementary (20 minutes a day) use of an intraoral vibrational device (AcceleDent; OrthoAccel Technologies, Houston, Tex) (n = 29), an identical nonfunctional (sham) device (n = 25), or fixed appliances only (n = 27). OIIRR was measured blindly from long-cone periapical radiographs of the maxillary right central incisor taken at the start of treatment and the end of alignment when a 0.019 × 0.025-in stainless steel archwire was placed (mean follow-up, 201.6 days; 95% confidence interval [CI], 188.6-214.6 days). Data were analyzed blindly on a per-protocol basis because losses to follow-up were minimal, with descriptive statistics, 1-way analysis of variance, and univariable and multivariable regression modeling.
Nine patients were excluded from the analysis; they were evenly distributed across the groups. Mean overall OIIRR measured among the 72 patients was 1.08 mm (95% CI, 0.89-1.27 mm). Multivariable regression indicated no significant difference in OIIRR for the AcceleDent (difference, 0.22 mm; 95% CI, -0.14-0.72; P = 0.184) and AcceleDent sham groups (difference, 0.29 mm; 95% CI, -0.15-0.99; P = 0.147) compared with the fixed-appliance-only group, after accounting for patient sex, age, malocclusion, extraction pattern, alignment time, maximum pain experienced, history of dentoalveolar trauma, and initial root length of the maxillary right central incisor. No other side-effects were recorded apart from pain and OIIRR.
The use of supplemental vibrational force during the alignment phase of fixed appliance orthodontic treatment does not affect OIIRR associated with the maxillary central incisor.
ClinicalTrials.gov (NCT02314975).
The protocol was not published before trial commencement.
Functional and sham AcceleDent units were donated by the manufacturer; there was no contribution to the conduct or the writing of this study.
在英国的1所大学和2家地区医院开展了一项多中心平行三臂随机临床试验，以研究在固定矫治器治疗排齐阶段补充振动力量对正畸诱导性炎性牙根吸收（OIIRR）的影响。
81名年龄小于20岁、下颌切牙不齐且接受拔牙后固定矫治器治疗的受试者被随机分配，分别为每天补充使用20分钟口内振动装置（AcceleDent；OrthoAccel Technologies公司，得克萨斯州休斯顿）（n = 29）、使用相同的无功能（假）装置（n = 25）或仅使用固定矫治器（n = 27）。在治疗开始时以及放置0.019×0.025英寸不锈钢弓丝的排齐阶段结束时，从右上颌中切牙的长锥根尖片上盲法测量OIIRR（平均随访201.6天；95%置信区间[CI]，188.6 - 214.6天）。由于失访极少，基于符合方案进行盲法数据分析，采用描述性统计、单因素方差分析以及单变量和多变量回归建模。
9名患者被排除在分析之外；他们在各组中分布均匀。72名患者的平均总体OIIRR为1.08毫米（95% CI，0.89 - 1.27毫米）。多变量回归表明，在考虑患者性别、年龄、错牙合畸形、拔牙模式、排齐时间、经历的最大疼痛、牙槽创伤史以及右上颌中切牙的初始牙根长度后，与仅使用固定矫治器组相比，AcceleDent组（差异为0.22毫米；95% CI， - 0.14 - 0.72；P = 0.184）和AcceleDent假装置组（差异为0.29毫米；95% CI， - 0.15 - 0.99；P = 0.147）的OIIRR无显著差异。除疼痛和OIIRR外，未记录到其他副作用。
在固定矫治器正畸治疗的排齐阶段使用补充振动力量不会影响与上颌中切牙相关的OIIRR。
ClinicalTrials.gov（NCT02314975）。
方案在试验开始前未发表。
功能性和假的AcceleDent装置由制造商捐赠；对本研究的实施或撰写无资助。
