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临床试验/CTRI/2025/10/095736
CTRI/2025/10/095736已完成不适用

Evaluation of white spot enamel lesion and bacterial adherence of Streptococcus mutans on maxillary anterior teeth following orthodontic bonding with primer and primer-free protocol: A randomized controlled trial

DR.VANDANA A1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2025年10月30日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
36
试验地点
1
主要终点
To quantify the adherence of Streptococcus Mutans on maxillary anterior teeth following orthodontic bonding with and without the use of primer

研究概览

简要总结

This is a double blinded, split mouth and randomized controlled trial to evaluate white spot enamel lesion and bacterial adherence of Streptococcus mutans on maxillary anterior teeth following orthodontic bonding with primer and primer-free protocol. It is conducted at VMSDC ,Salem. The primary outcome is to quantify Streptococcus mutans adherece on anterior teeth and the secondary objective is to record white spot enamel lesion. Streptococcus mutans quantification will be done using RT-PCR by using plaque sample collected surrounding the brackets.  Secondary outcome is assessed by Visual examination surrounding the brackets.

研究设计

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

入排标准

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

入选标准

  • Patients in age group between 18-30 years Patients requiring conventional fixed appliance therapy.
  • Mild irregularity index Absence of enamel defects on visual examination Patients with Oral Hygiene Index -Simplified score of 0.0 to 1.2 (good) and 1.3 to 3.0 (fair).

排除标准

  • Patients with craniofacial anomalies.
  • Patients requiring orthognathic surgery.
  • Patients with congenital as well as developmental enamel defects.

结局指标

主要结局

To quantify the adherence of Streptococcus Mutans on maxillary anterior teeth following orthodontic bonding with and without the use of primer

时间窗: Baseline, and after 6 months

次要结局

  • To compare the incidence of white spot enamel lesions on etched maxillary anterior teeth with & without the use of primer(baseline & 6 months)

研究者

发起方
DR.VANDANA A
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

DR VANDANA A

Vinayaka Missions Sankarachariyar Dental College

研究点 (1)

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