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

NCT06921434 | Not Yet Recruiting

• 1 other identifier: Mustansiriyah U
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Caries Active

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (3)

monk fruit sweetener group 30 participants

EXPERIMENTAL

Dietary Supplement: Monk fruit sweetener mouth rinse

Splenda (sucralose) sweetener group 30 participants

EXPERIMENTAL

Dietary Supplement: Splenda (sucralose) sweetener mouth rinse

positive control group (sucrose) 30 participants

ACTIVE COMPARATOR

Dietary Supplement: Sucrose mouth rinse

Interventions

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

monk fruit sweetener group 30 participants

Splenda (sucralose) sweetener mouth rinse DIETARY_SUPPLEMENT

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

Splenda (sucralose) sweetener group 30 participants

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

positive control group (sucrose) 30 participants

Eligibility Criteria

• Age: 20 Years - 24 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Al-Mustansiriyah University: lead

Study Sites (1)

Almustansiriyah university

Baghdad, Iraq, Iraq

Location

MeSH Terms

Interventions

trichlorosucrose

Central Study Contacts

Kawthar Salman Alharan, B.D.S

CONTACT

009647742276207; kawtharalharran@uomustansiriyah.edu.iq

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: master student

Model Details: 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

Study Record Dates

• First Submitted: April 1, 2025
• First Posted: April 10, 2025
• Study Start: October 1, 2025
• Primary Completion: November 1, 2025
• Study Completion: December 1, 2025
• Last Updated: September 24, 2025

Record last verified: 2025-09

Locations

IR (1)