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)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Caries Active
• Intervention / Treatment: Dietary supplement: Monk fruit sweetener mouth rinse; Dietary supplement: Splenda (sucralose) sweetener mouth rinse; Dietary supplement: Sucrose mouth 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.

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kawthar Salman Alharan, B.D.S; Phone Number: 009647742276207; Email: kawtharalharran@uomustansiriyah.edu.iq

Study Locations

• Iraq
  • Iraq
    • Baghdad, Iraq, Iraq
      • Almustansiriyah University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: monk fruit sweetener group 30 participants	Dietary supplement: 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
Experimental: Splenda (sucralose) sweetener group 30 participants	Dietary supplement: Splenda (sucralose) sweetener mouth rinse; 10 g of splenda powder with 90 ml of distilled water for 30 participants for 1 minute
Active Comparator: positive control group (sucrose) 30 participants	Dietary supplement: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
salivary ph measurement	the salivary ph will measure quantitatively using a ph meter	Baeline salivary ph measurement (before )using mouth rinse , after 1minute , after 15 minutes , and after 30 minutes of mouth rinse
Streptococcus mutans count measurement	streptococcus mutans count before mouth rinsing ,and after 30 minutes to evaluate the count if it increase or decrease	Baseline saliva collection for Streptococcus mutans count and 30 minutes after using mouth rinse saliva collection for Streptococcus mutans count

Collaborators and Investigators

• Sponsor: Al-Mustansiriyah University

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2025
• Primary Completion (Estimated): November 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: April 1, 2025
• First Submitted That Met QC Criteria: April 8, 2025
• First Posted (Actual): April 10, 2025

Study Record Updates

• Last Update Posted (Estimated): September 24, 2025
• Last Update Submitted That Met QC Criteria: September 23, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: trichlorosucrose
• Other Study ID Numbers: Mustansiriyah U

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No