Comparison of the efficacy of alignment using self-ligating brackets (SLB) and conventional MBT brackets - A SPLIT MOUTH STUDY.
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- To assess alignment efficacy during initial stage of fixed appliance therapy
研究概览
简要总结
The plaster models of either arches of the subjects were blindly coded for de-identification process, scanned using a 3D laser scanner and then rendered into a 3D stereolitographic digital model through specific software (3 Shape ortho analyser software or CAD-CAM). Little’s index irregularity (LII) digital measurements will be taken prior to treatment (T0). Self-ligating brackets were bonded to one quadrant of the either arches (right or left) and MBT preadjusted brackets were bonded to contralateral quadrant of the either arches at the same visit. A 0.016-inch Cu NiTi wire were used for alignment in both the groups for the period of six months. The conventional MBT brackets were fully ligated using elastomeric ligatures. No auxiliaries, such as lingual arches, bite plates or intermaxillary elastics will be used during the study period. After the period of 6 months, little’s irregularity index (LII) digital measurements will be repeated for post intervention assessment(T1) and calculation will be done for comparison of outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 12.00 Year(s) 至 20.00 Year(s)（—）
- 性别
- All
入选标准
- •Subjects in permanent dentition between the age group of 12-20 years both male and female.
- •Arch length – tooth size discrepancy in the range of 5-10mm in Lower arch.
- •Cases requiring first premolar extraction in mandibular arch on both sides as part of fixed appliance therapy.
- •Subjects with no active local (oral) or systemic diseases.
- •Subjects with good oral and general health.
排除标准
- •Subjects with previous history of extraction or orthodontic treatment.
- •Periodontally compromised teeth.
- •Poor oral hygiene.
- •Subjects hesitant to give consent to participate in the study.
结局指标
主要结局
To assess alignment efficacy during initial stage of fixed appliance therapy
时间窗: The duration of the study is 6 months
次要结局
- (Same as primary outcome) To assess alignment efficacy during initial stage of fixed appliance therapy(The duration of the study is 6 months)
研究者
M Keerthana
Government dental college Kottayam