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

NCT06921434 — Not applicable, Not yet recruiting, 90 participants, Al-Mustansiriyah University

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

RegistryNCT06921434
StatusNot yet recruiting
PhaseNot applicable
Study typeInterventional; randomized, parallel, masking: none, treatment
Enrollment90 (Estimated)
SponsorAl-Mustansiriyah University (Other)
ConditionsCaries Active
InterventionsMonk fruit sweetener mouth rinse, Splenda (sucralose) sweetener mouth rinse, Sucrose mouth rinse (Dietary supplement)
Datesstart 2025-10-01 (estimated), primary completion 2025-11-01 (estimated), completion 2025-12-01 (estimated), first posted 2025-04-10, last updated 2025-09-24
Locations1 site in Iraq

Related Papers Related Patents Related Grants Related Experts
All trials for Caries Active All trials of Monk fruit sweetener mouth rinse All trials of Splenda (sucralose) sweetener mouth rinse

-Summary

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.

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+Detailed description

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.

+Arms and interventions

ArmTypeInterventionsDescription
monk fruit sweetener group 30 participantsExperimentalDietary Supplement: Monk fruit sweetener mouth rinse
Splenda (sucralose) sweetener group 30 participantsExperimentalDietary Supplement: Splenda (sucralose) sweetener mouth rinse
positive control group (sucrose) 30 participantsActive comparatorDietary Supplement: Sucrose mouth rinse
  • 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

+Outcome measures

Primary outcomes

  • salivary ph measurement [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
  • Streptococcus mutans count measurement [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

+Eligibility

Sex: All, ages: 20 Years to 24 Years, accepts healthy volunteers

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

+Locations (1)

FacilityCityCountryStatus
Almustansiriyah universityBaghdad, IraqIraq