MINI IMPLANTS PLACED AT INFRAZYGOMATIC CREST VERSUS INTERRADICULAR SITES 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
- 1
- 主要终点
- skeletal and dental cephalometric variables
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 at infrazygomatic or interradicular sites.
Aims and Objectives: To evaluate the treatment changes achieved in class II division 1 malocclusion during en- masse retraction of upper anterior teeth using mini-implants placed at infrazygomatic crest versus interradicular sites.
To compare patients' and orthodontist's perceptions of treatment being done in both the groups.
Method of study: Treatment will be initiated by bilateral maxillary 1st premolar extraction followed 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 and then randomized allocation of the patients into 2 groups-G1 and G2 will be done. G1 will receive infrazygomatic crest mini-implants bilaterally and G2 will receive bilateral interradicular mini-implants. Hooks will be soldered on archwire used for stabilizing dentition. Ni-Ti closed coil spring will be used to apply force.
详细描述
The present study is a randomized clinical trial , non-pharmacological, double blind, to evaluate the treatment changes achieved in class II division 1 malocclusion during en-masse retraction of upper anterior teeth using mini-implants placed at infrazygomatic crest versus interradicular sites. 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.
Inclusion criteria:- Non growing patients with 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.
Exclusion Criteria:- 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.
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 . The patient will be given 72 hours to discuss the study with his/her family and take the decision regarding participation in the study.
RANDOMIZATION & ALLOCATION CONCEALMENT Randomization will be done by a person not involved in the trial using computer generated randomization list. The study subjects will be blinded regarding intervention group.
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 30 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Non growing patients
- •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.
- •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
研究组 & 干预措施
Retraction of anterior teeth using mini implants placed at infrazygomatic crest.
bilateral extraction of maxillary first premolars before initial leveling and alignment followed by retraction of anterior teeth using mini implants placed at infrazygomatic crest
干预措施: retraction of anterior teeth using mini implants placed at infrazygomatic crest. (Procedure)
Retraction of anterior teeth using mini implants placed at interradicular sites.
bilateral extraction of maxillary first premolars before initial leveling and alignment followed by retraction of anterior teeth using mini implants placed at interradicular sites.
干预措施: retraction of anterior teeth using mini implants placed at interradicular sites. (Procedure)
结局指标
主要结局
skeletal and dental cephalometric variables
时间窗: 15 months
Comparison of pretreatment and post 6 month evaluation of skeletal and dental cephalometric variables between the two groups Skeletal cephalometric variables 1. SNA: SN to NA angle 2. A-NPerp: linear distance from A-point to nasion-perpendicular(a line perpendicular to Frankfort plane, through nasion) 3. SNB: SN to NB angle 4. SND: SN to ND angle 5. LAFH (lower anterior face height): distance from anterior nasal spine to menton. Dental cephalometric variables 1. Mx1.NA: maxillary incisor long axis to NA angle 2. Mx1-NA: distance between the maxillary central incisor edge and the NA line 3. Mx1-VRL: distance from the maxillary central incisor edge to VRL (vertical reference line passing through sella and perpendicular to horizontal line constructed by reducing 7° from SN line) 4. Mx6-VRL: distance from maxillary first molar mesial cusp to VRL 5. Md1.NB: mandibular incisor long axis to NB angle 6. Md1-NB: distance between the mandibular central incisor edge and the NB line.
次要结局
- soft tissue variables between the two groups(15 months)