跳至主要内容
临床试验/NCT04686617
NCT04686617已完成不适用

The Effect of Twelve Weeks of Mechanical Vibration on Root Resorption: A Micro-Ct Study

Yeditepe University0 个研究点目标入组 20 人开始时间: 2013年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
20
主要终点
Orthodontically induced inflammatory root resorption (OIIRR)

研究概览

简要总结

The aim of this study was to investigate the effect of mechanical vibration on root resorption with or without the application of orthodontic force.

Twenty patients who required maxillary premolar extractions as part of their orthodontic treatment were randomly separated into two groups of 10: no-force group and force group. Using a split-mouth procedure, each patient's maxillary first premolar teeth were randomly assigned as either vibration or control side in both groups. Buccally directed vibration of 113 Hz, using an Oral-B HummingBird device with a modified tip, was applied to the maxillary first premolar for 10 mins/day during 12 weeks. After the force application period, the maxillary first premolars were extracted and scanned with micro-computed tomography. Fiji(ImageJ) which made slice-by-slice quantitative volumetric measurements was used for resorption crater calculation. Total crater volumes was compared with Wilcoxon and Mann-Whitney U tests.

详细描述

The sample included 40 maxillary first premolars from 20 orthodontic patients (7 boys and 13 girls; range: 15.08-18.58 years; mean: 16.77 years) who required bilateral maxillary first premolar extractions as part of their orthodontic treatment. They were recruited according to strict selection criteria as described previously.These included need for bilateral maxillary first premolar extractions (necessitating moderate anchorage) and fixed appliance treatment; permanent dentition; completion of apexification; similar minimal crowding on each side of the maxillary arch; no previous orthodontic or orthopedic treatment; no unilateral or bilateral posterior crossbites; no craniofacial anomaly; no history of trauma, bruxism, or parafunction; no past or present signs and symptoms of periodontal disease; no significant medical history that would affect the development or structure of the teeth and jaws and any subsequent tooth movement; and no history of asthma. The sample size was calculated by using Piface 1.72, and guaranteed 82.56% power. This number was reached by considering the standard deviation of 0.46mm3 in our previous similar study. True difference of means was estimated at 0.2mm3, and type I error(α) was accepted as the standard value .05.

Ethics approval was obtained from the Ethics Committee of Bulent Ecevit University (2012/23). All subjects and their guardians consented to participate in this study after receiving verbal and written explanations.

Impressions were taken with alginate of the maxillary jaw only to construct the appliance. The study model was obtained by pouring hard plaster. On this model, the transpalatal arch was formed by bending a 0.09 mm steel wire between the maxillary right and left first molar teeth. To prevent potential contact of the teeth during buccal movement to the transpalatal arch, occlusion rising acrylic plates were added. The acrylic plates were of mean 2mm thickness to only include occlusion of the first molar teeth. After fitting the transpalatal arches in the mouth, light-cured glass ionomer cement (TransbondTM Plus, 3M Unitek, Monrovia, USA) was applied to the maxillary first molar teeth of all the patients. After these procedures, the patients were randomly separated into 2 equal groups. Randomization was made using the Excel program (Microsoft, Redmond, WA, USA), and allocation was hidden in consecutively numbered, closed envelopes. Blinding was used for treatment and outcome assessments.

No-force group: The right and left side first premolar teeth were randomly assigned (split-mouth design) so that mechanical vibration was applied in the buccal direction on one side and the other side was used as the premolar tooth control group. Oral B Hummingbird device (Procter&Gamble, USA) with a modified tip was used for the application of vibration. The tip was positioned mid-buccally of teeth to perform buccally directed vibration. HummingBird is prescribed maximum period 0.00885s corresponding to 6800RPM or 113Hz of the motor. The vibration procedure was applied for 10mins/day during the period of 12 weeks. At the end of the 12th week, the first stage was completed and the first premolar teeth were extracted.

Force group: The right and left side first premolar teeth were randomly assigned (split-mouth design) so that mechanical vibration was applied in the buccal direction to one side and the other side was used as the premolar tooth control group. As in no-force group, same device procedure was used for the application of vibration. Self-ligating Speed (Strite Industries, Cambridge, Ontario, Canada) tubes and brackets with 0.022×0.026 inch slots were bonded to the buccal surfaces of the right and left first molar teeth and first premolar teeth.150g of buccally directed forces, producing by a 0.017×0.025-in beta-titanium-molybdenum alloy (3M Unitek, Monrovia, Calif) cantilever spring, were applied to premolar teeth on both side. The force magnitude was measured with a strain gauge (Dentaurum). At the end of the 12th week, the first stage was completed and the first premolar teeth were extracted.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
Single (Participant)

入排标准

年龄范围
15 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Need for bilateral maxillary first premolar extractions (necessitating moderate anchorage) and fixed appliance treatment
  • •Permanent dentition
  • •Completion of apexification
  • •Similar minimal crowding on each side of the maxillary arch

排除标准

  • •Previous orthodontic or orthopedic treatment
  • •Unilateral or bilateral posterior crossbites
  • •Craniofacial anomaly
  • •History of trauma, bruxism, or parafunction
  • •Past or present signs and symptoms of periodontal disease
  • •Significant medical history that would affect the development or structure of the teeth and jaws and any subsequent tooth movement
  • •History of asthma

研究组 & 干预措施

Force Group

Active Comparator

The right and left side first premolar teeth were randomly assigned (split-mouth design) so that mechanical vibration was applied in the buccal direction to one side and the other side was used as the premolar tooth control group. As in no-force group, same device procedure was used for the application of vibration. Self-ligating Speed (Strite Industries, Cambridge, Ontario, Canada) tubes and brackets with 0.022×0.026 inch slots were bonded to the buccal surfaces of the right and left first molar teeth and first premolar teeth.150g of buccally directed forces, producing by a 0.017×0.025-in beta-titanium-molybdenum alloy (3M Unitek, Monrovia, Calif) cantilever spring, were applied to premolar teeth on both side.The force magnitude was measured with a strain gauge (Dentaurum). At the end of the 12th week, the first stage was completed and the first premolar teeth were extracted.

干预措施: Mechanical Vibration (Diagnostic Test)

No-force group

No Intervention

The right and left side first premolar teeth were randomly assigned (split-mouth design) so that mechanical vibration was applied in the buccal direction on one side and the other side was used as the premolar tooth control group. Oral B HummingBird device (Procter&Gamble, USA) with a modified tip was used for the application of vibration. The tip was positioned mid-buccally of teeth to perform buccally directed vibration. HummingBird is prescribed maximum period 0.00885s corresponding to 6800RPM or 113Hz of the motor. The vibration procedure was applied for 10mins/day during the period of 12 weeks. At the end of the 12th week, the first stage was completed and the first premolar teeth were extracted.

结局指标

主要结局

Orthodontically induced inflammatory root resorption (OIIRR)

时间窗: 12 weeks

Orthodontically induced inflammatory root resorption (OIIRR) or, as it is better known, root resorption, is an unavoidable pathologic consequence of orthodontic tooth movement. It is a certain adverse effect of an otherwise predictable force application.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Hakan Yılmaz

Assistant Professor

Yeditepe University

相似试验