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

Not Applicable

Not yet recruiting

• Conditions: Caries Active

• Registration Number: NCT06921434
• Lead Sponsor: Al-Mustansiriyah University

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.

Study Timeline

• Study First Submitted: 2025-04-01
• Study First Submitted QC: 2025-04-08
• Study First Posted: 2025-04-10
• Status Verified: 2025-09
• Last Update Submitted: 2025-09-23
• Last Update Posted: 2025-09-24
• Study Start: 2025-10-01
• Primary Completion: 2025-11-01
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 90

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Almustansiriyah university; 🇮🇶 Baghdad, Iraq, Iraq