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Набор скоро начнётся NCT06902532

Effectiveness of Coconut Oil Pulling With Clove Oil, Coconut Oil Pulling and Fluoride Mouthwash on Streptococcus Mutans Count in Children

Без фазы С лечением Dental Caries

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: coconut oil pulling with clove oil, coconut oil pulling, Fluoride Mouthwash.
Кому может быть актуально
Состояния в реестре: Dental Caries. Базовые параметры: 6 лет — 12 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
Египет
Следующий шаг
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Обзор

This study aims to compare the effectiveness of coconut oil pulling with clove oil, coconut oil pulling alone, and fluoride mouthwash in reducing Streptococcus mutans levels in children aged 6-12 years. Participants will be randomly assigned to one of three groups: 1. Coconut Oil Pulling with Clove Oil Group - Daily swishing with coconut oil mixed with clove oil. 2. Coconut Oil Pulling Group - Daily swishing with coconut oil alone. 3. Fluoride Mouthwash Group (Control) - Using fluoride mouthwash as per standard guidelines. The primary outcome is the reduction in Streptococcus mutans count, assessed through microbiological analysis of saliva samples at baseline, immediately after intervention, and after 4 weeks. Secondary outcomes include patient acceptability, adherence, and gingival health. This randomized controlled trial will provide insight into natural alternatives for oral health maintenance in children. Study Location: Cairo University, Faculty of Dentistry. Estimated Study Duration: May 2025 - January 2026.

Подробное описание

This study is a three-arm, randomized controlled trial assessing the impact of coconut oil pulling with clove oil compared to coconut oil alone and fluoride mouthwash on Streptococcus mutans reduction in children. Participants will be recruited from the Pediatric Dentistry Department at Cairo University and randomly assigned using a 1:1:1 allocation ratio.

Saliva samples will be collected at three time points (baseline, immediately after intervention, and 4 weeks post-intervention) for microbiological analysis. The study will also evaluate secondary outcomes such as patient compliance (measured using the MMAS-4 scale), acceptability (using a 5-point Likert scale), and gingival health (assessed with the Löe \& Silness Gingival Index).

The findings aim to determine whether natural oil-based methods can serve as effective, non-invasive alternatives to fluoride-based mouth rinses in pediatric populations.

Вмешательства

  • Поведенческое coconut oil pulling with clove oil
    Participants will swish 10 mL of coconut oil mixed with 2 drops of clove oil once daily for 4 weeks. This intervention is designed to assess its antimicrobial efficacy in reducing Streptococcus mutans levels in children and improving oral hygiene.
  • Поведенческое coconut oil pulling
    Participants will swish 10 mL of pure coconut oil once daily for 4 weeks. This intervention aims to evaluate the effectiveness of coconut oil alone in reducing Streptococcus mutans levels and its potential role in maintaining oral health.
  • Препарат Fluoride Mouthwash
    Participants will rinse with 10 mL of fluoride mouthwash three times daily for 4 weeks. This intervention serves as the active comparator, as fluoride mouthwash is a well-established method for reducing Streptococcus mutans levels and preventing dental caries.

Первичные конечные точки

  • streptococcus mutans count [Срок оценки: Baseline (T0), immediately after intervention (T1), and after 4 weeks (T2).]

Критерии участия

Критерии включения

  • 1.Children aged 6-12 years old. 2.Both male and female participants. 3.Patients in good general health condition with no systemic disease. 4.Patients' first guardians must provide written informed consent to participate in the study

Критерии исключения

  • 1.Patients who have recently received fluoride treatments (within the last 2 weeks).

2.Patients with a history of recent antibiotic administration (within the last 2 weeks).

3.Patients who have recently used antimicrobial mouth rinses in the last 12 hours or topical fluoride treatments.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Тройное слепое
Основная цель
Профилактика

Центры проведения

Египет · 2 центра
  • Faculty of Dentistry-Cairo university — Cairo
  • Faculty of Dentistry Cairo university — Egypt

Идентификаторы

NCT: NCT06902532 · COPCO-2025 · self funded study

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗