跳至主要内容
临床试验/CTRI/2026/02/103290
CTRI/2026/02/103290尚未招募不适用

Evaluation And Comparison of the Efficacy of Oil Pulling and Herbal Mouthwash Against Commercially Available Fluoride Mouthwash on Caries Activity of Lactobacillus: An In Vivo study

Department of Pediatric and Preventive Dentistry1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2026年3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
48
试验地点
1

研究概览

简要总结

Randomized, controlled, four-arm parallel-group clinical trial will be conducted among children aged 7–12 years presenting at the Out-patient Department of Pediatric and Preventive Dentistry, D.Y. Patil University, School of Dentistry, Navi Mumbai.

After thoroughly explaining the technique, informed consent from parents willing to participate in the study will be obtained, the children will then be randomized into 4 groups using parallel-group design.

 

  • Group 1 – Oil Pulling Group
  • Group 2 – Fluoride Mouthwash Group
  • Group 3 – Herbal Mouthwash Group
  • Group 4 – Control Group (Distilled Water)

 To maintain standardization all participants will undergo oral prophylaxis prior to the commencement of the study. Along with that, they will also be provided by all the necessary material required for intervention.

 Participants in Group 1 will be instructed to swish their oral cavity with one teaspoon (5 mL) of virgin coconut oil for 5 minutes on an empty stomach and spit the oil, followed by rinsing with warm water and brushing their teeth with a standard toothpaste.

 Participants in Group 2 will be instructed to brush their teeth with standard toothpaste, followed by rinsing with fluoride mouthwash as per the manufacturer’s instructions (10 mL for 1 minute)

 Participants in Group 3 will be instructed to brush their teeth with standard toothpaste followed by swishing the oral cavity using Herbal mouthwash as per manufacturer’s instructions (10 mL for 1 minute)

 Participants in Group 4 will be instructed to brush their teeth with standard toothpaste, followed by swishing with 10 ml distilled water.

 To ensure proper adherence to the procedure, a weekly chart will be provided to the parent or guardian of each participant. Additionally, participants will be asked to send a daily video demonstrating the intervention being performed.

 Intervention will be conducted over a period of two weeks. Saliva samples will be collected at two time points: baseline and at two weeks post-intervention. Each sample would be plated for microbiological analysis with quantification of CFU of Lactobacilli.

Saliva samples will be collected using a sterile cotton swab from the affected tooth and placed directly into a sterile tube. These samples will be stored at 4°C in a refrigerator until they are transported to a regional microbiology laboratory in an insulated ice box.

 Once at the laboratory, the samples will be diluted and gently mixed to ensure uniformity. A 100 µL of the saliva sample will be streaked onto Blood agar plates using a sterile loop, and the sample will be evenly spread with a sterile spreader. The plates will then be incubated at 37°C for 48 hours under microaerophilic conditions.

 After incubation, the colonies will be examined for morphological characteristics. Further identification of the colonies will be performed using biochemical tests, such as Gram staining and the catalase test. The lactobacillus colonies will be counted using a colony counter.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Investigator Blinded

入排标准

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

入选标准

  • Children between 7 to 12 years of age Normal healthy children ASA I and II Written informed consent signed by parents.

排除标准

  • ASA III and IV Systemic disease Severe periodontal disease Oral infection or pathology Known allergy to oil, herbal content, or fluoride use of any antibiotics or probiotics or mouthwash within last four weeks History of dental treatment in last six months Consent not given by parents.

研究者

发起方
Department of Pediatric and Preventive Dentistry
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dr Shilpa S Naik

DY PATIL DEEMED TO BE UNIVERSITY SCHOOL OF DENTISTRY

研究点 (1)

Loading locations...

相似试验