Comparison Between Effectiveness of Different Esthetic Orthodontic Appliances in Management of Lower Anterior Teeth Relapse: a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Resolution of lower anterior teeth crowding
研究概览
简要总结
The purpose of this study is to compare the effectiveness of active fixed lingual wire, removable aligners, and lingual braces in managing crowding of the lower anterior teeth resulting from relapse. The study intends to evaluate these interventions concerning the degree of alignment achieved in the lower anterior teeth, treatment duration, patient discomfort, patient acceptance, gingival inflammation and the cost effectiveness.
详细描述
- Background Orthodontic relapse can be defined as the tendency for teeth to return to their pre- treatment position and this particularly occurs in the lower anterior teeth. Retention, to maintain teeth in their corrected position, has become one of the most important phases of orthodontic treatment, however, studies have revealed that the long-term alignment of the lower front teeth following orthodontic treatment was unsatisfactory. Post-treatment alignment (assessed by Little's irregularity index) may be maintained in only 30% to 50% of orthodontic patients over 10 years.
Certain critical factors may contribute to the relapse of the lower front teeth. These include reorganization of the periodontal tissue, decrease of the crestal alveolar bone level, over- expansion of the arch dimension, occlusal changes due to mandibular growth, eruption of the third mandibular molars, type of malocclusion being treated and adverse effects of tooth movement during treatment.
While labial braces may be the most effective method to correct relapse of lower front teeth, their use may be undesirable as patients may be reluctant to go through the experience of fixed brackets again.
Active fixed lingual wire, removable aligners and fixed lingual braces are considered esthetic options to manage such condition. Aligners may address the demand for an esthetic alternative but could prove to be an expensive option and patient cooperation is mandatory. Fixed lingual braces may be more effective in correcting the relapse but their use may be undesirable due to speech problems, and tongue irritability.
A recent cochrane systematic review assessing the the effects of interventions used to manage relapse of the lower front teeth stated that there is a need for rigorously conducted, and reported, RCTs to be undertaken to assess the effects of different approaches to orthodontic re- treatment following relapse of lower front teeth alignment. 2. Research Hypothesis:
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)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Mild to moderate lower incisors crowding. (Little irregularity index of 3-6 mm)
- •Relapse from previous non extraction orthodontic treatment that finished at least 1 year before the study.
- •Patient refuses to go through full comprehensive orthodontic treatment.
排除标准
- •Extracted or missing lower incisor or lower canine.
- •Orthodontic patients who experienced relapse and were treated with extractions.
- •Medically compromised patients.
- •Hypersensitivity or allergy to any material involved in the study.
- •Patients suffering from any congenital, hereditary or systemic disease.
- •Root resorption in lower anterior teeth.
- •Carious or fractured lower anterior teeth.
研究组 & 干预措施
Aligners
The upper and lower arches will be intra orally scanned followed by fabrication of in office aligners for the lower arch using 3shape software.
干预措施: Aligners (Device)
Lingual braces
2D lingual braces will be indirectly bonded to the lower anterior teeth from canine to canine.
干预措施: Lingual braces (Device)
Active fixed lingual wire
A customized 14 nickel-titanium archwire was placed on the lingual surfaces of the lower anterior teeth and secured through ligature wires passing through the contact points.
干预措施: Active fixed lingual wire (Device)
结局指标
主要结局
Resolution of lower anterior teeth crowding
时间窗: 6 months
This outcome was detected through measurement of the mean change in the little irregularity index which is defined as the sum of the linear distances between the anatomical contact points of the mandibular incisors. The little irregularity index will be measured using 3shape ortho analyzer software.
次要结局
- Gingival inflammation(This outcome will be recorded at 4 timepoints, Pre treatment, 4 weeks after treatment, 12 weeks after treatment, Post treatment or after 6 months of treatment.)
- Treatment Duration(6 months)
- Patient expectations(6 months)
- Pain reported on Visual analogue scale(This outcome will be recorded at 8 time points which are: Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7 and Day 14.)
研究者
Assem Gamaleldin Esmat Mohamed Gamil
Dr
Cairo University