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Идёт набор NCT07619014

Comparison of the Effectiveness of Miswak and Manual Toothbrush in Removing Dental Plaque in Fixed Orthodontic Patients

Без фазы С лечением Dental Plaque Orthodontic Patients

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Natural Miswak (Al-Kureysh, Pakistan), Manual Toothbrush (Colgate Zig Zag, China).
Кому может быть актуально
Состояния в реестре: Dental Plaque, Orthodontic Patients. Базовые параметры: 18 лет — 30 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Syria
Следующий шаг
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Официальное название

Comparison of the Effectiveness of Miswak and Manual Toothbrush in Removing Dental Plaque in Fixed Orthodontic Patients: A Randomized Split-Mouth Clinical Trial

Обзор

This study compares the immediate plaque removal efficacy of the natural Miswak versus a traditional manual toothbrush using the Modified Bass technique among orthodontic patients. The main question it aims to answer is: Are there statistically significant differences in the post-brushing plaque index reduction between the dental arch side cleaned with Miswak and the contralateral side cleaned with a manual toothbrush?

Подробное описание

The maintaining of excellent oral hygiene is a significant challenge for patients undergoing orthodontic treatment due to the presence of fixed brackets and archwires, which act as retentive areas for dental biofilm accumulation. While the conventional manual toothbrush is widely prescribed, the natural Miswak (Salvadora persica) serves as a popular traditional oral hygiene tool with documented mechanical and antimicrobial properties. However, there is a lack of split-mouth clinical trials directly evaluating and comparing their immediate mechanical efficacy in the presence of orthodontic appliances.

This study utilizes a split-mouth experimental design to minimize inter-individual variability, where each participant serves as their own control. The mouth of each patient is randomized to use the natural Miswak on one side and the conventional manual toothbrush on the contralateral side during a single clinical session with no subsequent follow-up.

Aim: To evaluate and compare the immediate efficacy of the natural Miswak versus a manual toothbrush (using the Modified Bass technique) in reducing dental plaque scores among a sample of patients with fixed orthodontic appliances at Al-Hawash Private University.

Вмешательства

  • Устройство Natural Miswak (Al-Kureysh, Pakistan)
    * Preparation: 1-2 cm of outer bark removed, soaked in water for 10-15 mins, and fibers frayed. * Technique: Vertical strokes (gum to tooth), horizontal on occlusal, focusing around brackets. * Duration: 3 to 5 minutes.
  • Устройство Manual Toothbrush (Colgate Zig Zag, China)
    * Technique: Modified Bass Technique (bristles at 45-degree angle to gingival margin, short vibratory movements) modified to brush above and below orthodontic brackets. * Duration: 3 to 5 minutes.

Первичные конечные точки

  • Modified Quigley-Hein Plaque Index (mQH) Score [Срок оценки: Baseline (immediately before brushing) and Post-intervention (immediately after brushing within the same single clinical session).]

Критерии участия

Критерии включения

  • Patients aged between 18 and 30 years old.
  • Presence of fixed orthodontic appliances (brackets and wires) on both upper and lower arches.
  • Good general systemic health with the absence of any medical conditions that might affect oral health status.

Критерии исключения

  • Presence of advanced or aggressive periodontal diseases.
  • Current smokers.
  • Use of antimicrobial or antibacterial mouthwashes within 24 hours prior to the study session.
  • Systemic antibiotic intake within the past 2 weeks preceding the experiment.
  • Any physical or motor disability that could hinder the patient's capacity to perform proper tooth brushing.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Факторный дизайн
Маскирование
Простое слепое
Основная цель
Поддерживающая терапия

Центры проведения

Syria · 1 центр
  • Al-Hawash Private University, Faculty of Dentistry — Homs

Идентификаторы

NCT: NCT07619014 · 26-06-2025

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗