Osseous Evidence Behind Micro-osteoperforation Technique in Accelerating Orthodontic Tooth Movement Towards Reducing Treatment Duration.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- To investigate the effects of micro-osteoperforations (MOPs) on mandibular bone volume fraction (BV/TV).
研究概览
简要总结
Introduction
The study aimed to investigate the effects of micro-osteoperforations (MOPs) on the changes in mandibular bone volume fraction (Bone Volume/Total Volume, BV/TV), in relation to the MOP effects on the rate of orthodontic tooth movement, using CBCT images. The other objective was to evaluate the effects of different frequency intervals (4 weeks, 8 weeks and 12 weeks) of MOPs on mandibular bone volume fraction (BV/TV), in relation to the rate of tooth movement.
Methods
In 24 participants, orthodontic force of 140-200 grams was applied for mandibular canine retraction. Three micro-osteoperforations (MOP's) were made according to the scheduled intervals of the three different groups (4, 8 and 12 weeks) directly at the mandibular buccal cortical bone of extracted first premolars sites. At the 12th week following MOP application, CBCT scans were performed. CT Analyser software was used to compute trabecular alveolar bone volume fraction (BV/TV).
详细描述
This study is a single centred, single-blinded, prospective randomised split-mouth clinical trial conducted at University of Malaya. The ethical approval for the present study was obtained from the institutional Medical Ethics Committee (DF CD1608/0059P). Written informed consents were obtained from all participants prior to the study. Cone beam computed tomography (CBCT) (Kodak 9000) images was used to assess the trabecular alveolar bone volume fraction (BV/TV) at micro-osteoperforations (MOPs) sides. The rate of orthodontic tooth movement was assessed by comparing the available space between control and MOP sites in three different interval groups. Twenty-four participants were selected according to the study selection criteria. Inclusion criteria was (1) aged 18 years and above at the start of the treatment, (2) molar relationship either Class I, < ½ unit Class II or Class III, (3) extraction of all four first premolar teeth as part of orthodontic treatment, (4) maximum anchorage required using mini-implant, (5) no systemic disease, (6) good oral hygiene and (7) no periodontal disease. Participants were excluded if they had significant vertical skeletal discrepancies, systemic diseases requiring long-term antibiotic use, phenytoin, cyclosporin, anti-inflammatory drugs, bisphosphonates, systemic corticosteroids or calcium channel blockers, poor oral hygiene for more than visits or active periodontal disease.
Sample size calculation
G*Power software (version 3.1.9.2) was used to calculate the total sample size of 24 using t tests to achieve a power of 80% and a level of significance of 5% (two sided), for detecting an effect size of 0.60 between pairs. However, 30 samples were selected to compensate for any dropouts during the study.
Demographic characteristic
Twenty-four participants were stratified in 3 study groups (4, 8 and 12 weeks) based on frequency intervention intervals. Ethnically, there were 11 Malay samples (45.8%), 10 Chinese samples (41.7%) and 3 Indian samples (12.5%). Gender and ethnic distribution was not equal within the study groups due to the limited sample size, as a result gender variance was not assessed in the present study.
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 (Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 18 years and above at the start of the treatment.
- •Molar relationship either Class I, < ½ unit Class II or Class III.
- •Extraction of all four first premolar teeth as part of orthodontic treatment.
- •Maximum anchorage required using mini-implant.
- •No systemic disease.
- •Good oral hygiene.
- •No periodontal disease.
排除标准
- •Significant vertical skeletal discrepancies.
- •Systemic diseases requiring long-term antibiotic use, phenytoin, cyclosporin, anti- inflammatory drugs, bisphosphonates, systemic corticosteroids or calcium channel blockers.
- •Poor oral hygiene.
- •Active periodontal disease.
研究组 & 干预措施
Control and experimental (4 weeks MOP)
This is a split mouth study. At the experimental site in group 1, three Micro-osteoperforation (MOP) were made directly at the buccal cortical bone of extracted first premolars sites, at equidistance from the canine and second premolar under local anaesthesia. This group received four sessions of MOPs at an interval of 4 weeks.
干预措施: Micro-osteoperforation (MOP) (Procedure)
Control and experimental ( 8 weeks MOP)
This is a split mouth study. This group received 2 sessions of Micro-osteoperforation (MOP) at an interval of 8 weeks.
干预措施: Micro-osteoperforation (MOP) (Procedure)
Control and experimental (12 weeks MOP)
This is a split mouth study. This group received 2 sessions of Micro-osteoperforation (MOP) at an interval of 12 weeks.
干预措施: Micro-osteoperforation (MOP) (Procedure)
结局指标
主要结局
To investigate the effects of micro-osteoperforations (MOPs) on mandibular bone volume fraction (BV/TV).
时间窗: 9 months
BV/TV ratio was assessed between control and intervention sides to assess the effects of micro-osteoperforations (MOPs) on the changes in mandibular bone volume fraction (Bone Volume/Total Volume, BV/TV ).
To investigate the effects of micro-osteoperforations (MOPs) on the rate of orthodontic tooth movement.
时间窗: 3 months
The effect of MOPs on the rate of canine tooth movement was assessed by comparing the distance of canine retraction between control and micro-osteoperforations sides.
次要结局
- The other objective was to evaluate the effects of different frequency intervals (4 weeks, 8 weeks and 12 weeks) of MOPs on mandibular bone volume fraction (BV/TV).(9 months)
研究者
Wey Mang Chek
Assoc. Prof.
University of Malaya