A Comparative Evaluation of Root Resorption Using CBCT, Patients and Orthodontists Perceptions in Class II Division I Malocclusion With Bilateral Extraction of Maxillary First Premolar vs Full Arch Distalization : A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- 1.To quantify root resorption seen with bilateral extraction of maxillary first premolars (followed by en-masse retraction of anterior teeth) vs maxillary full arch distalization using zygomatic miniplates in Class II division 1 malocclusion.
研究概览
简要总结
Rationale: Class II Division 1 malocclusion is characterized by upper anterior teeth protrusion resulting in upper lip protrusion and convex facial profile, which are considered esthetically unfavorable. Treatment of class II malocclusion due to maxillary protrusion can be done with bilateral maxillary first premolar extraction followed by en-masse retraction of upper anterior teeth using mini implants placed between maxillary 2nd premolar & 1st molar.
Treatment of class II malocclusion due to maxillary protrusion without premolar extraction frequently requires distalization of maxillary molars into Class I molar relation by means of extra-oral or intraoral forces. Absolute skeletal anchorage, available 24 hours a day is an alternative method for molar distalization. Zygomatic miniplates fixed at a distance from the root apices, allows distalization of entire dentition as there is no interference between the fixation device and roots of the teeth.
Aims and Objectives: To quantify root resorption seen with bilateral extraction of maxillary first premolars (followed by en - masse retraction of anterior teeth) vs full arch distalization with zygomatic miniplates in Class II Division I malocclusion.
Method of study: Patients will be allocated randomly to 2 groups-G1 and G2. Patients in G1 will undergo bilateral maxillary 1st premolar extraction before bonding followed by leveling & alignment. Maxillary arch will be stabilized with the help of 0.019"×0.025" stainless steel wire. Hooks will be soldered on archwire used for stabilizing dentition. Mini implants will be placed under local anaesthesia between maxillary 2nd premolar & 1st molar. Ni-Ti closed coil spring will be used to apply a force for en masse retraction of maxillary anterior teeth .
In G2, treatment will be initiated by bonding 0.022" slot MBT preadjusted edgewise appliance. Maxillary arch will be stabilized with the help of 0.019"×0.025" stainless steel wire. Zygomatic miniplates will be placed bilaterally. Hooks will be soldered on archwire used for stabilizing dentition. Ni-Ti closed coil spring will be used to apply a force .
详细描述
The present study is a prospective, non-pharmacological, single blind, randomized clinical study to quantify root resorption seen with bilateral extraction of maxillary first premolars (followed by en - masse retraction of anterior teeth) vs full arch distalization with zygomatic miniplates in Class II Division I malocclusion. The present study will be conducted in the Department of Orthodontics and Dentofacial Orthopaedics, in conjunction with the Department of Oral and Maxillofacial Surgery, P.G.I.D.S., Pt. B.D.Sharma University of Health Sciences, Rohtak. The study will be carried out after the institutional approval obtained from the ethical committee.
SOURCE OF DATA The study sample consists of 30 subjects selected from the patients attending the regular OPD at the Department of Orthodontics and Dentofacial Orthopaedics for orthodontic treatment.
Patients who fail to follow up or undergo complete treatment TARGET SAMPLE SIZEA sample size of 14 per group for the present study was calculated to detect a clinical difference of 0.25 with a pooled standard deviation of 0.2 (effect size 1.56) at 90% power and 95% confidence interval.
To compensate for 10% dropouts the final sample size was calculated to be 15 per group.
INFORMED CONSENT OF THE PATIENT AND AGREEMENT TO BE RANDOMIZED A valid, written informed consent of the patient or parent/ guardian and an agreement to be randomized will be obtained from the patient before registering the patient in this clinical study. Patient will be informed about all the theoretical risks and benefits of the intervention under test (Annexure I). The patient will be given 72 hours to discuss the study with his/her family and take the decision regarding participation in the study.
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 (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Non growing patients
- •Complete bilateral Class II molar relationship at pre-treatment
- •All permanent teeth upto the second molars should be present
- •No or minor crowding in the maxillary arch
- •Horizontal to average growth pattern.
排除标准
- •Subjects with a history of fixed orthodontic treatment.
- •Crossbite
- •Vertical growth pattern
- •Any systemic disease affecting bone and general growth
- •Poor oral hygiene
- •Cleft patients
- •Patients who fail to follow up or undergo complete treatment
结局指标
主要结局
1.To quantify root resorption seen with bilateral extraction of maxillary first premolars (followed by en-masse retraction of anterior teeth) vs maxillary full arch distalization using zygomatic miniplates in Class II division 1 malocclusion.
时间窗: 34 MONTHS
pre treatment and post treatment cbct has been assessed to measure the root resorption of maxillary teeth in millimetres 2. To compare both patients' and orthodontist's perceptions of treatment being done in both the groups.
次要结局
- patient and orthodontist perception(34 months)