Duration Of Lower Labial Segment Alignment With Repeated Micro-Osteoperforations: Randomised Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- 4. To compare the duration to align the lower labial segment (33-43), between micro-osteoperforations and control group in the irregular review group.
研究概览
简要总结
The main purpose is to compare overall alignment time (OAT) in days in alleviating mandibular incisors crowding between control group and MOPs group.Furthermore, to investigate the presence of volumetric root resorption from CBCT, gingival recession and formation of black triangle post lower labial segment alignment between micro-osteoperforations group and control group.
详细描述
Prolonged treatment time in orthodontics is an undesirable side effect for both the patient and clinician. Usually, an average course of comprehensive orthodontic treatment with fixed appliances requires less than 2 years to complete (19.9 months). This prolonged treatment time may cause adverse effects such as root resorption, gingival recession, caries & enamel demineralization. Micro-osteoperforations is safe, minimally invasive technique which perforations are performed through the gum tissues, penetrating the bone without the need to raise a flap.Control group will not received any MOP and will receive standard orthodontic treatment.
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
Blinding of either patient or clinician is not possible during allocation, treatment and data collection. However, blinding can be ensured during data processing, analysing stages and data collection for secondary outcomes on total volume of root resorption from CBCT, formation of black triangle and gingiva recession
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Gender : Male and Female
- •Age range : ≥ 18years to 45 years old
- •Crowding of 3mm - 7mm on lower labial segment (lower right canine to lower left canine) which does not require extractions in the lower arch
- •Class II div I Incisor relationship with extraction of both upper 1st premolars
- •Maximum anchorage control with temporary anchorage device ( TAD) , with Molar Class II (¼ to full unit) malocclusion
- •Average vertical facial proportions
- •No systemic disease
- •Acceptable good oral hygiene
- •No periodontal disease
排除标准
- •Distally angulated canines
- •History of trauma (crown fracture or avulsion and re-implantation) , endodontic treatment
- •Missing permanent mandibular anterior teeth ( Hypodontia) / Retained deciduous teeth in mandibular anterior area
- •Habits eg: fingernails biting , toothpick user , using hard toothbrush
- •Vertical skeletal discrepancies eg high angle and low angle
- •Systemic disease especially on long term use of antibiotics, phenytoin, cyclosporin, anti-inflammatory drugs, systemic corticosteroid and calcium channel blockers
- •Poor oral hygiene for more than 3 visits
- •Current periodontal disease
研究组 & 干预措施
Micro-osteoperforations
Lower arch, 2 MOPs vertically at interdental area bilaterally mesial to lower 6's ; mesial to lower 1st premolar; mesial to lower 2's and between the lower 1's..The start date of lower labial segment alignment (T1) was recorded after insertion of the lower 0.014'' NiTi archwire. Participants were reviewed every 6 weeks and repeated MOPs were performed for the experimental group until the completion of lower labial segment alignment (LLS), which is when the Little's irregularity index scores one, indicating a minimum irregularity of ≤ 2 mm contact point displacement, based on the contact point displacements of the mandibular anterior segment, from canine to canine.
干预措施: Micro-osteoperforations (Device)
control
Conventional orthodontic treatment without any aid in tooth acceleration method / device
结局指标
主要结局
4. To compare the duration to align the lower labial segment (33-43), between micro-osteoperforations and control group in the irregular review group.
时间窗: 5 months
Total treatment time needed to achieved lower labial segment alignment until Little's irregularity index scores one, indicating a minimum irregularity of ≤ 2 mm contact point displacement, based on the contact point displacements of the mandibular anterior segment, from canine to canine
1. To compare the duration to align the lower labial segment (33-43), between regular and irregular review groups from the conventional (control group).
时间窗: 5 months
Total treatment time needed to achieved lower labial segment alignment until Little's irregularity index scores one, indicating a minimum irregularity of ≤ 2 mm contact point displacement, based on the contact point displacements of the mandibular anterior segment, from canine to canine
2. To compare the duration to align the lower labial segment (33-43), between regular and irregular review groups from the micro-osteoperforations group.
时间窗: 5 months
Total treatment time needed to achieved lower labial segment alignment until Little's irregularity index scores one, indicating a minimum irregularity of ≤ 2 mm contact point displacement, based on the contact point displacements of the mandibular anterior segment, from canine to canine
3. To compare the duration to align the lower labial segment (33-43), between micro-osteoperforations and control group in the regular review group.
时间窗: 5 months
Total treatment time needed to achieved lower labial segment alignment until Little's irregularity index scores one, indicating a minimum irregularity of ≤ 2 mm contact point displacement, based on the contact point displacements of the mandibular anterior segment, from canine to canine
次要结局
- Total volume of root resorption with micro-osteoperforations group vs the control group(5 months)
- Gingival recession between micro-osteoperforations and control group.(5 months)
- Black triangle between micro-osteoperforations and control group.(5 months)