Evaluation of the Efficacy of One-jaw Versus Tow-jaw Mechanics for Mini-implants Anchored Total-maxillary-arch-distalization in the Treatment of Class II Division 1 Malocclusion A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Change in the MM angle
研究概览
简要总结
Patients with class II division 1 malocclusion who have increased overjet will be treated in this study. The efficacy of one-jaw and tow-jaw mechanics for mini-implants anchored total-maxillary-arch-distalization in the treatment of class II division 1 malocclusion will be assessed. The skeletal, dental and soft tissues changes resulted by these tow interventions will be studied. As well as, the pain levels, oral-health related quality of life during all stages of the treatment and the smile components will be explored and compared with the traditional treatment results of this type of malocclusion (en-mass retraction with first premolars extraction).
There are three groups :
- a group of patients in which participants will be undergo to the one-jaw mechanic for mini-implants anchored total-maxillary-arch-distalization (mini-implants in the maxillary arch).
- a group of patients in which participants will be undergo to the tow-jaw mechanic for mini-implants anchored total-maxillary-arch-distalization (mini-implants in the mandibular arch with class II elastics).
- a group of patients in which participants will be undergo to the en-mass retraction with first premolars extraction with mini-implants in the maxillary arch.
详细描述
The number of adults seeking active orthodontic treatment has been increasing over the past several decades. Older patients tend to show a greater demand for esthetic considerations during and after active treatment. Also, the preservation of existing dentoalveolar structures becomes a more critical issue in their treatment, and this mandates vigilant monitoring of the periodontal and occlusal statuses throughout the course of tooth movement.
Nowadays, the tendency towards choosing nonextraction approaches has been increasing because of the availability of effective and minimally invasive treatment modalities. Several strategies have been introduced to address the arch length discrepancy by gaining space through enamel stripping, arch expansion, and distalization of dentition. Moreover, the introduction of temporary anchorage devices (TADs) has enhanced the efficiency of nonextraction therapies via improved anchorage management.
The total-maxillary-arch-distalization is a treatment modality respect the principle of structures preservation and the esthetic demands of patients.
Most of the published literature were case reports or retrospective studies so, there is a high need for a randomized controlled trial to assess some of these suggested approaches.
The current study will have three parallel arms as following:
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
- 17 Years 至 30 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients with permanent occlusion at age 18-30 years.
- •Comprehensive medical and dental history ruling out any systemic disease
- •Not under any systemic medication.
- •No previous orthodontic treatment
- •Patients with satisfactory periodontal health and Good oral hygiene
- •Need to orthodontic treatment with fixed appliances
- •No congenitally missing teeth except third molars in the maxillary arch
- •Mild or no anterior crowding in maxillary arch.
- •Patients with class Ⅱ division 1 (ANB angle ≤7 degrees) with severe overjet (5-9 mm)
- •Maximum retraction of the anterior teeth was desired.
排除标准
- •Patients with previous orthodontic treatment.
- •Patients with severe skeletal dysplasia in all three dimensions.
- •Patients suffer from systemic diseases or syndromes
- •Patients on medication for systemic disorders, pregnancy or steroid therapy.
- •Patients showing any signs of active periodontal disease
- •Patients with severe crowding (≥ 3.5 mm) in maxillary arch
- •Patients with missing or extracted teeth in maxillary arch except third molar.
结局指标
主要结局
Change in the MM angle
时间窗: : T0: 1 day before the beginning of active treatment . T1: when a normal overjet and canines class I relationships achieved (expected to be within 6 months in the exp. groups and 8 months in the control group
This angle the represents the amount of vertical divergence between the upper and lower jaws in the cephalometric analysis. Lateral cephalograms will be taken and this angle is going to be measured in degrees.
Duration of the treatment
时间窗: duration (in months) between T0: the beginning of active treatment, T1: when a normal overjet and canines class I relationships achieved. (expected to be within 6 months in the exp. groups and 8 months in the control group)
Assessment will be performed by calculating the months required to achieve a normal overjet and canines class I relationships through clinical examination
Change in the Incisors' positions
时间窗: : T0: 1 day before the beginning of active treatment . T1: when a normal overjet and canines class I relationships achieved (expected to be within 6 months in the exp. groups and 8 months in the control group
Amount of distance being traveled by the retracted anterior teeth is going to be measured on study models taken when a normal overjet and canines class I relationships will be achieved.
Change in the ANB angle
时间窗: : T0: 1 day before the beginning of active treatment . T1: when a normal overjet and canines class I relationships achieved (expected to be within 6 months in the exp. groups and 8 months in the control group
This angle the represents the spatial relationship between the upper and lower jaws in the cephalometric analysis in the anteroposterior direction. Lateral cephalograms will be taken and this angle is going to be measured in degrees.
Change in the nasolabial angle
时间窗: : T0: 1 day before the beginning of active treatment . T1: when a normal overjet and canines class I relationships achieved (expected to be within 6 months in the exp. groups and 8 months in the control group
This angle the represents the relationship of the upper lip with the nose in the cephalometric analysis. Lateral cephalograms will be taken and this angle is going to be measured in degrees.
Change in the SNA angle
时间窗: : T0: 1 day before the beginning of active treatment . T1: when a normal overjet and canines class I relationships achieved (expected to be within 6 months in the exp. groups and 8 months in the control group
This angle represents the position of the upper jaw in the cephalometric analysis in the anteroposterior direction. Lateral cephalograms will be taken and this angle is going to be measured in degrees.
Change in the SN.GoMe angle
时间窗: : T0: 1 day before the beginning of active treatment . T1: when a normal overjet and canines class I relationships achieved (expected to be within 6 months in the exp. groups and 8 months in the control group
This angle the represents the amount of backward rotation of the lower jaw in the cephalometric analysis. Lateral cephalograms will be taken and this angle is going to be measured in degrees.
Change in Molars' positions
时间窗: : T0: 1 day before the beginning of active treatment . T1: when a normal overjet and canines class I relationships achieved (expected to be within 6 months in the exp. groups and 8 months in the control group
Amount of distance being traveled by the first molars and is going to be measured on study models taken when a normal overjet and canines class I relationships will be achieved.
Change in the SNB angle
时间窗: : T0: 1 day before the beginning of active treatment . T1: when a normal overjet and canines class I relationships achieved (expected to be within 6 months in the exp. groups and 8 months in the control group
This angle the represents the position of the lower jaw in the cephalometric analysis in the anteroposterior direction. Lateral cephalograms will be taken and this angle is going to be measured in degrees.
次要结局
- Change in the smile components(T0: 1 day before the beginning of the treatment . T1: at the end of the treatment (expected to be within 6 months in the exp. groups and 8 months in the control group))
- Change in the levels of spontaneous and chewing pain(Levels of pain will be assessed at : immediately after the begging of the distalization or retraction (T1), 6 hours (T2) , 24 hours (T3) , 48 hours (T4), 1 week (T5) and 24 hours of each force activation.)