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临床试验/CTRI/2025/01/079375
CTRI/2025/01/079375已完成4 期

Evaluation of rate of tooth movement during en-masse distalisation of mandibular teeth with and without Piezocision for correction of Angle’s Class III Malocclusion - A Randomized Clinical trial.

Akshaya. K1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2025年2月7日最近更新:

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
12
试验地点
1
主要终点
Rate of retraction during en mase distalisation in class III malocclusion

研究概览

简要总结

This is a randomised controlled trial evaluating the efficiency of piezocision on the rate of tooth movement during enmasse distalisation of mandible during class III correction. 2 groups of patients will be included in the study (experimental and control group). Prior to retraction pre op CBCT will be taken for both the groups. Patients in the experimental group will undergo piezocision corticotomy. Vertical interproximal incisions of 10mm length will be made 4mm below the interdental papilla on the buccal aspect of mandible, mesial to first molars, mesial and distal to canines bilaterally post which Piezocision knife will be used for alveolar decortication to a length of 5 to 8mm and depth of about 3mm. Anchorage will be obtained from stainless steel orthodontic mini-implants  of 2mm diameter and 8mm or 10 mm length placed in buccal shelf of the mandible on right and left side using NiTi closed coil springs in both the groups.  Post op CBCT will be taken for both the groups post class 1 molar achievement. Primary outcome will be to analyse the rate of tooth movement during enmasse distalisation in correction of class III Malocclusion.  Secondary outcomes include, Axial inclination of mandibular central incisors, Root resorption of mandibular teeth, Pain perception, Gingival status, soft tissue healing and, Pulp vitality.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Outcome Assessor Blinded

入排标准

年龄范围
15.00 Year(s) 至 30.00 Year(s)(—)
性别
All

入选标准

  • 1.Patients undergoing fixed orthodontic treatment and enmasse retraction of mandibular teeth with skeletal anchorage for correction of Angle’s class III Malocclusion.
  • Patients with good oral hygiene, good periodontal and gingival health and with no history of systemic diseases.
  • Patients who aren’t under any medication that can affect bone biology.

排除标准

  • 1.Patients with Mal-occlusion other than Class III.
  • 2.Patients on antibiotics, anti- inflammatory or steroidal drugs.
  • 3.Patients with pre-existing psychiatric or those undergoing psychiatric therapy.
  • 4.Patients with any congenital cranio- facial anomaly, or those affected by cranio-facial syndromes.
  • Patients who did not consent to participate in this study or those not willing to undergo Piezocision procedure.

结局指标

主要结局

Rate of retraction during en mase distalisation in class III malocclusion

时间窗: Prior to initiation of enmasse distalisation of mandibular teeth and after achievement of class 1 molar relationship

次要结局

  • 1. Axial inclination of mandibular central incisors(2. Root resorption of mandibular teeth)

研究者

发起方
Akshaya. K
申办方类型
Other [Self Sponsoring]
责任方
Principal Investigator
主要研究者

Akshaya k

SRM dental college

研究点 (1)

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