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临床试验/CTRI/2025/07/091332
CTRI/2025/07/091332尚未招募不适用

Comparative Evaluation of the Effect of Pre-Fabricated and Conventional Band and Loop Space Maintainer on Post-Extraction Wound Healing and Assessment of Plaque Accumulation and Gingival Health of the Abutment Tooth: A Split Mouth Randomized Controlled Trial

Kalyani Barve1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年8月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
30
试验地点
1
主要终点
Wound Healing

研究概览

简要总结

Conventional band and loop space maintainers are widely used for space maintenance but have drawbacks such as soldering failures and multiple appointments. Prefabricated space maintainers address this by requiring less time and only one appointment. However, space maintainers may affect post-extraction wound healing and plaque accumulation, leading to gingivitis. Objective: This study aims to compare the effects of prefabricated and conventional band and loop space maintainers on post-extraction wound healing, plaque accumulation, and gingival health of the abutment tooth. Methodology: Split mouth study will include 10 healthy children aged five to eight years with bilateral mandibular primary first molars indicated for extraction. Each patient’s experimental side will be randomly selected, dividing quadrants into two groups: Conventional and Prefabricated Band and Loop space maintainers. Follow-up appointments will be scheduled on 3rd and 7th day post-extraction to assess wound healing using Landry index, and at 1st, 2nd, and 3rd months to assess plaque using Plaque index and gingival health of abutment using Gingival index.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
5.00 Year(s) 至 8.00 Year(s)(—)
性别
All

入选标准

  • Bilateral primary mandibular first molars indicated for extraction, Presence of a succedaneous tooth bud confirmed radiographically, Healthy abutment tooth, Adequate bone coverage that indicates more than 6 months remained until permanent tooth eruption.

排除标准

  • Succedaneous tooth with more than 1/3rd of root already calcified, Space left by prematurely lost teeth is greater than space needed for the permanent successor, Succedaneous tooth is absent, Medically compromised children and children with special health care needs.

结局指标

主要结局

Wound Healing

时间窗: Day 3 and Day 7

次要结局

  • Plaque accumulation & Gingival health status(Baseline, 1 month, 2 months, 3 months)

研究者

发起方
Kalyani Barve
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Kalyani Barve

Government Dental College and Hospital, Mumbai

研究点 (1)

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