the Effect of Monk Fruit and Splenda on Salivary Ph and Streptococcus Mutans Count in Vivo Study

Официальное название

Comparative Evaluation of Monk Fruit and Splenda on Salivary ph and Streptococcus Mutans Growth (an in Vivo Study)

Обзор

This study aims to evaluate the changes in salivary pH and Streptococcus mutans count by preparing a solution containing these sweeteners dissolved in distilled water and administering it to the participants. Saliva samples will be collected before using the mouth rinse, and salivary pH will be measured using a pH meter, while S. mutans count will be analyzed in the laboratory. After consuming the solution, salivary pH will be assessed at 1 minute, 15 minutes, and 30 minutes, while the growth of S. mutans will be examined 30 minutes post-rinse.

Подробное описание

90 participants who meet the inclusion criteria-having no active caries, aged between 20 and 24 years, and not taking medications that affect saliva-will be included in the study. They will be divided into three groups of 30 participants each based on the type of sweetener used, along with a control group that will receive sucrose.

The solution will be prepared by dissolving 10 grams of the sweetener in 90 mL of distilled water and will be freshly prepared daily. A saliva sample will be collected from each participant before using the rinse, and salivary pH will be measured using a salivary pH meter. Additionally, the Streptococcus mutans count will be determined through incubation and culture.

Participants will use the mouth rinse for one minute, after which saliva samples will be collected at baseline (before rinsing), then at 1 minute, 15 minutes, and 30 minutes post-rinse. The salivary pH will be measured and recorded at each time point. The S. mutans count will be assessed before rinsing and again 30 minutes after using the solution.

Вмешательства

• Пищевая добавка Monk fruit sweetener mouth rinse
  monk fruit mouth rinse 10 grams of sweetener powder and 90 ml of distilled water for 30 participants for 1 minute
• Пищевая добавка Splenda (sucralose) sweetener mouth rinse
  10 g of splenda powder with 90 ml of distilled water for 30 participants for 1 minute
• Пищевая добавка Sucrose mouth rinse
  10 g of sucrose powder dissolved in 90 ml of distilled water as a positive control group for 30 participants for 1 minute

Первичные конечные точки

• salivary ph measurement [Срок оценки: Baeline salivary ph measurement (before )using mouth rinse , after 1minute , after 15 minutes , and after 30 minutes of mouth rinse]
• Streptococcus mutans count measurement [Срок оценки: Baseline saliva collection for Streptococcus mutans count and 30 minutes after using mouth rinse saliva collection for Streptococcus mutans count]

Критерии участия

Критерии включения

participants aged (20-24) years.

• No active carious lesions or oral diseases.
• Generally healthy individuals without systemic illnesses.
• No prior use of preventive dental treatments

Критерии исключения

• Participants currently undergoing dental treatment.
• Those taking medications that alter saliva flow.
• Presence of painful oral conditions or systemic diseases. Participants have active caries

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Ирак · 1 центр

• Almustansiriyah university — Baghdad

Идентификаторы

NCT: NCT06921434 · Mustansiriyah U

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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