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临床试验/CTRI/2025/04/084988
CTRI/2025/04/084988尚未招募不适用

A Comparison of Efficacy of Probiotic Toothpaste and Probiotic Mouthwash to Reduce Streptococcus Mutans in Plaque Around Orthodontic Brackets: An In Vivo Study

Dr Jainil Patel1 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2026年10月3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
54
试验地点
1
主要终点
Compare antimicrobial property of probiotic mouthwash and probiotic toothpaste

研究概览

简要总结

54 patients undergoing orthodontic treatment will be selectedrandomly. These patients will be divided into three groups of 18 patients each: Group 1: - Control Group, Group 2: - Probiotic Toothpaste, Group 3: - Probiotic Mouthwash.

Samples will be collected at two different occasions: Before the study begins (Phase 1)(T0) and After thirty days (Phase 2) (T1).

Plaque specimens willbe collected from the labial surfaces immediately surrounding the orthodonticbrackets of the maxillary lateral incisors with a sterilized scaler.

To check the anti-microbial effect, plaque sample collected in containerwill be inoculated in Luria Broth for isolation of S. mutans. Grown culturewill be used for serial dilution, plated on chrome agar plates for specificidentification of bacterial growth. The different colour colonies will befurther inoculated in Luria Broth and will be incubated overnight at 37°C forgrowth.  Bacterial isolate will be usedfor genomic DNA extraction, G DNA will be isolated using Genomic DNA extractionkit, followed by 16srdna using universal primers for 16srDNA, PCR samples willbe confirmed on (0.8%) agarose gel electrophoresis. PCR sample will be purifiedusing PCR clean up kit. PCR cleanup product will be sent for sequencing.  Protocol used for PCR amplification will befollowed accordingly. Thermocycle conditions are 94°C 3 minutes, 94°C 45seconds, 50°C 60 seconds, 72°C 90 seconds, Repeat steps 2-4 35 times, 72°C 10minutes, 4°C HOLD.

ForResults – Colony Forming Units (CFU) will be counted.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Outcome Assessor Blinded

入排标准

年龄范围
12.00 Year(s) 至 35.00 Year(s)(—)
性别
All

入选标准

  • 1.Patients who received fixed orthodontic treatment for at least three months.
  • 2.No systemic illnesses like diabetes mellitus or immunological diseases like AIDS Healthy periodontium.

排除标准

  • Composite restorations and prosthetic crowns on anterior teeth Patients with Oral Hygiene Index-Simplified (OHI-S) score more than 3 Teeth with developmental anomalies or fluorosis Patients on medication like phenytoin, or immunosuppressants Need for anti-inflammatory or antibiotic medication Pregnant women and smokers History of frequent vomiting.

结局指标

主要结局

Compare antimicrobial property of probiotic mouthwash and probiotic toothpaste

时间窗: at baseline and at 4 weeks

次要结局

未报告次要终点

研究者

发起方
Dr Jainil Patel
申办方类型
Other [self]

研究点 (1)

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