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

NCT ID: NCT06921434

Last Updated: 2025-09-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-01

Study Completion Date

2025-12-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Caries Active

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

monk fruit sweetener group 30 participants

Group Type EXPERIMENTAL

Monk fruit sweetener mouth rinse

Intervention Type 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 group 30 participants

Group Type EXPERIMENTAL

Splenda (sucralose) sweetener mouth rinse

Intervention Type DIETARY_SUPPLEMENT

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

positive control group (sucrose) 30 participants

Group Type ACTIVE_COMPARATOR

Sucrose mouth rinse

Intervention Type 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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type DIETARY_SUPPLEMENT

Splenda (sucralose) sweetener mouth rinse

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

Intervention Type 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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

20 Years

Maximum Eligible Age

24 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Al-Mustansiriyah University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Kawthar Salman Alharan

master student

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Almustansiriyah university

Baghdad, Iraq, Iraq

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Iraq

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Kawthar Salman Alharan, B.D.S

Role: CONTACT

009647742276207

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Mustansiriyah U

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Miswak Efficacy Compared With Chlorhexidine
NCT04607785 COMPLETED EARLY_PHASE1
The Effect of Oral Sprays on Salivary pH
NCT06148662 COMPLETED PHASE4
Anti-gingivitis Mouthrinse
NCT06048627 COMPLETED PHASE3