Efficiency Of Micro-osteoperforation During Alignment Stage
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Rate of Mandibular Teeth Alignment
研究概览
简要总结
Prolonged orthodontic treatment increases the risc of caries, periodontal problems and root resorption. Many different techniques were developed to shorten the treatment time. The aim of this study was to evaluate the effectiveness of micro-osteoperforations (MOP) performed in the alignment stage.
Twenty eight patients with mandibular arch discrepancy will be included in this research. After the patients are informed about the study they will be requested to sign the consent form.. At the beginning of the treatment routine orthodontic records (photographs, dental models and radiographs) will be taken and the gingival pocket measurements will be made.
The twenty eight patients will be randomly divided in two groups. In the first group, 3 or 4 micro-osteoperforations will be made in the parts of the gingiva nearby the discrepancy by perforating the keratinized or non-keratinized mucosa and reaching the alveolar bone under local anesthesia. In the further appointments the traditional aligning procedures will be used and controls will be made every 7-9 days. In the other group 20 patients will be treated in the traditional way and controls will be made each month. Every patient will be requested to answer questions related to treatment comfort and other problems like pain within the first week after each activations. The records will be repeated after the leveling phase. Tooth movement rate will be calculated according to the measurements made on dental casts. Measurements related to cephalometrics and gingival thickness will be evaluated. The results of two groups will be compared in terms of tooth movement rate, gingival thickness, pain and patient comfort.
详细描述
Twenty eight patients who have crowding in mandibular arch will be included in the study.
At the beginning of the study, routine orthodontic records and gingival measurements will be taken.All the records will be repeated after alignment stage.
Clinical periodontal parameters including plaque index, gingival index, pocket depth and bleeding were measured with Williams periodontal scaler (Hu Friedy®, Chicago, IL, USA).
Gingival thickness will be recorded with a ultrasonic device (Pirop® Ultrasonic Biometer A- Scan, Echo-Son, Krancowa, Poland) Irregularity index will be calculated for each patient using dental casts. After bracket placement; twenty eight patients will be randomly allocated to treatment and control groups (fourteen patients in each group) While micro-osteoperforations will be applied to treatment group, the control group will receive no additional treatment.
Each patient will be asked to fulfill a questionnaire to evaluate patient satisfaction and ease of operation.
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
single outcome assessor
入排标准
- 年龄范围
- 12 Years 至 30 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Existence of all permanent teeth (except molars 2 and 3)
- •Subjects aged 30 and below
- •Confusion of less than 8 mm according to model analysis of the upper and lower sieves
- •Gingival and periodontal indices of less than 1
- •Good oral hygiene
排除标准
- •Congenitally missing tooth
- •Severe skeletal malocclusion
- •Systemic disease affecting tooth movement
- •Active periodontal disease
- •Radiographically detected bone loss
- •Gingival pocket depth greater than 4 mm
- •Previous surgical periodontal or orthodontic treatment
研究组 & 干预措施
conventional treatment
conventional fixed appliance treatment
干预措施: conventional fixed appliance treatment (Other)
micro-osteoperforation
Propel device (ABD) Micro-osteoperforations were performed in the keratinized tissue. Micro-osteoperforations were 1.5 mm in diameter and 3-7 mm in depth.
干预措施: micro-osteoperforation (Device)
micro-osteoperforation
Propel device (ABD) Micro-osteoperforations were performed in the keratinized tissue. Micro-osteoperforations were 1.5 mm in diameter and 3-7 mm in depth.
干预措施: conventional fixed appliance treatment (Other)
结局指标
主要结局
Rate of Mandibular Teeth Alignment
时间窗: From the initiation of the treatment to the completion of alignment stage (approximately 6 months)
tooth movement rate (mm/month) was calculated. From the initiation of the treatment to the completion of alignment stage (approximately 6 months). All tooth movement rate measurements were performed in each month.
次要结局
未报告次要终点
研究者
Asli Baysal
Assoc. Prof. Dr.
Izmir Katip Celebi University