Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT06921434

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

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Age range

20 year–24 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Almustansiriyah university

Baghdad, Iraq

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Monk fruit sweetener mouth rinse

Dietary Supplement

monk fruit mouth rinse 10 grams of sweetener powder and 90 ml of distilled water for 30 participants for 1 minute

Splenda (sucralose) sweetener mouth rinse

Dietary Supplement

10 g of splenda powder with 90 ml of distilled water for 30 participants for 1 minute

Sucrose mouth rinse

Dietary Supplement

10 g of sucrose powder dissolved in 90 ml of distilled water as a positive control group for 30 participants for 1 minute

Primary outcomes

  1. salivary ph measurement

    Time frame: Baeline salivary ph measurement (before )using mouth rinse , after 1minute , after 15 minutes , and after 30 minutes of mouth rinse

    the salivary ph will measure quantitatively using a ph meter

  2. Streptococcus mutans count measurement

    Time frame: Baseline saliva collection for Streptococcus mutans count and 30 minutes after using mouth rinse saliva collection for Streptococcus mutans count

    streptococcus mutans count before mouth rinsing ,and after 30 minutes to evaluate the count if it increase or decrease

Study contacts

Contact information is provided by the study sponsor or research team.

Kawthar Salman Alharan, B.D.S

CONTACT

[email protected]

009647742276207

Sponsors and collaborators

Lead sponsor

Al-Mustansiriyah University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Apr 10, 2025
Registry last updated
Sep 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.