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临床试验/NCT07445321
NCT07445321已完成不适用

Comparison of Rate and Amount of Orthodontic Space Closure After All First Premolars Extraction in Healed vs Fresh Extraction Sites. A Randomized Clinical Trial.

Dow University of Health Sciences1 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2023年2月15日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
34
试验地点
1
主要终点
To compare rate of space closure among fresh vs healed extraction sites during fixed orthodontic treatment in patients with all first premolar's extraction.

研究概览

简要总结

The goal of this clinical trial is to compare rate and amount of space closure among fresh vs healed extraction sites during fixed orthodontic treatment in patients with all first premolar's extraction Primary outcome measure is to calculate rate and amount of space closure between fresh vs healed as well as maxilla and mandible.

详细描述

The mandibular and maxillary arches of 34 patients will be included whose treatment plan decision was the extraction of all first premolars. Due to the split mouth approach, patients' maxillary and mandibular arches are randomly subdivided into two groups (right and left sides). First premolar extraction spaces in Group 1 will be closed once they have healed (6 week), while first premolar extraction spaces in Group 2 will be closed immediately after extraction. Both the upper and lower extraction spaces will be closed using coil springs (magnitude of force 30g per side). We'll specify the following time intervals: T1: Immediately prior to space closure; T2: 1 month after initial space closure; T3: 2 months after initial space closure T3: 3 months after initial space closure. Records will include measuring the rate and amount of space closure through Vernier calipers on dental cast as well as intraorally and will be evaluated at each time point.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Patients aged 18-35 years.
  • Patients undergoing fixed appliance treatment.
  • Good oral hygiene and periodontal support.
  • Patients with all first premolar's extraction treatment plan.
  • Atraumatic extraction.

排除标准

  • History of previous orthodontic treatment
  • Systemic diseases like diabetes, hypertension etc
  • Any bone pathology or taking medicines like bisphosphonates
  • Patients with clefts or any syndromic condition.
  • Patients with old extraction socket.

研究组 & 干预措施

fresh vs healed extraction socket

Experimental

Comparison of rate and amount of space closure in fresh vs healed extraction socket

干预措施: Space Closure (Procedure)

结局指标

主要结局

To compare rate of space closure among fresh vs healed extraction sites during fixed orthodontic treatment in patients with all first premolar's extraction.

时间窗: four time points are taken. T0: Baseline, T1: One month, T2: Two months, T3: Three months

This study will be useful in making the timely decision for extraction of premolars and estimation of orthodontic treatment duration as well.

次要结局

  • To compare amount of space closure among fresh vs healed extraction sites during fixed orthodontic treatment in patients with all first premolar's extraction.(Space closure at T3 is subtracted from T0)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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