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

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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06921434
Enrollment
90
Registered
2025-04-10
Start date
2025-10-01
Completion date
2025-12-01
Last updated
2025-09-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Caries Active

Brief 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.

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.

Interventions

DIETARY_SUPPLEMENTMonk 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

DIETARY_SUPPLEMENTSplenda (sucralose) sweetener mouth rinse

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

DIETARY_SUPPLEMENTSucrose 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

Sponsors

Al-Mustansiriyah University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

parallel Assignment 90 participants will divided into 3 groups (Monk fruit ,Splenda ,and control group sucrose)and each group will receive only one intervention without switching

Eligibility

Sex/Gender
ALL
Age
20 Years to 24 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
salivary ph measurementBaeline salivary ph measurement (before )using mouth rinse , after 1minute , after 15 minutes , and after 30 minutes of mouth rinsethe salivary ph will measure quantitatively using a ph meter
Streptococcus mutans count measurementBaseline saliva collection for Streptococcus mutans count and 30 minutes after using mouth rinse saliva collection for Streptococcus mutans countstreptococcus mutans count before mouth rinsing ,and after 30 minutes to evaluate the count if it increase or decrease

Countries

Iraq

Contacts

Primary ContactKawthar Salman Alharan, B.D.S
kawtharalharran@uomustansiriyah.edu.iq009647742276207

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026