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临床试验/NCT07409610
NCT07409610已完成不适用

Effectiveness of a 45°-Cut Miswak (Salvadora Persica) Versus a Toothbrush in Plaque Removal Among Children: A Randomized Split-Mouth Clinical Trial

King Abdulaziz University1 个研究点 分布在 1 个国家目标入组 82 人开始时间: 2025年9月12日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
82
试验地点
1
主要终点
The plaque index score

研究概览

简要总结

The study investigates the effectiveness of a 45°-cut miswak for plaque removal compared to a toothbrush in children and assesses their preferences for these tools. Conducted at King Abdulaziz University Dental Hospital, it employs a split-mouth randomized controlled trial design to measure plaque levels and gather feedback through a questionnaire.

详细描述

Miswak provides both mechanical and chemical cleaning. Its fibrous structure enables mechanical removal of debris from tooth surfaces and interdental areas, while naturally occurring compounds (e.g., fluoride, silica, and calcium) may contribute to its anticariogenic effects. Studies have reported that miswak exhibits antibacterial, antifungal, antiviral, anti-cariogenic, and antioxidant effects, and molecular docking studies have suggested potential anti-COVID-19 activity.

One of the studies has shown that miswak can reduce oral bacterial load, in some cases more effectively than conventional toothpaste particularly against Streptococcus mutans and Lactobacilli, key contributors to dental caries. Miswak-based toothpaste and mouthwash have also been associated with significant reductions in plaque levels and improved gingival health, suggesting that miswak could be a viable and affordable oral hygiene option, especially for children in underserved or resource-limited communities

Methods:

This research employs a split-mouth randomized controlled trial (RCT) design that compared the effectiveness of a 45-degree cut Miswak stick versus a manual toothbrush in reducing dental plaque among children aged 6 to 14 years. The study focused on evaluating intra-individual differences in plaque accumulation by assigning each child to use Miswak on one side of the mouth and a toothbrush on the opposite side. This split-mouth approach aims to minimize variability and enhance statistical reliability.

This design supported intra-individual comparison and enhanced the study's internal validity.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Investigator)

盲法说明

The study used single blinding, meaning the examiners didn't know which side of the mouth was treated with Miswak or toothbrush to avoid bias in their assessments. Since the tools used (Miswak and toothbrush) looked different, it wasn't possible to blind the participants or their parents.

入排标准

年龄范围
6 Years 至 14 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Healthy children aged 6 to 14 years.
  • Children who their parents/legal guardians have approved and signed the consent form, which ensures that the participants are within the target age range and are healthy, which helps to control variables that could affect oral hygiene outcomes.

排除标准

  • Unhealthy children
  • Children whose ages are below 6 years or above 14 years
  • Children with orthodontic brackets because it can affect oral hygiene practices and outcomes, excluding these participants ensures a more homogeneous sample.

研究组 & 干预措施

Intervention (Miswak)

Experimental

This arm introduces a 45° miswak technique, which aligns with the modified Bass method by angling the miswak fibers at 45° toward the gingival margin

干预措施: Miswak (Other)

Control (Tooth brushing)

Active Comparator

Participants in this arm used the modified bass technique using normal tooth brush and tooth paste

干预措施: Toothbrush (Other)

结局指标

主要结局

The plaque index score

时间窗: At baseline and after 3 weeks

The plaque index score, a continuous measure assessed using the Simplified Oral Hygiene Index (OHI-S) developed by Greene and Vermillion (1964) (Greene and Vermillion 1964)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Heba sabbagh

Professor

King Abdulaziz University

研究点 (1)

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