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

Al-Mustansiriyah University

Status: Not yet enrolling

Conditions: Caries Active

Treatments: Dietary Supplement: Monk fruit sweetener mouth rinse; Dietary Supplement: Sucrose mouth rinse; Dietary Supplement: Splenda (sucralose) sweetener mouth rinse

Study type: Interventional

Funder types: Other

Identifiers

NCT06921434

Mustansiriyah U

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 estimated patients

Sex: All

Ages: 20 to 24 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 3 patient groups

monk fruit sweetener group 30 participants

Experimental group

Treatment:

Dietary Supplement: Monk fruit sweetener mouth rinse

Splenda (sucralose) sweetener group 30 participants

Experimental group

Treatment:

Dietary Supplement: Splenda (sucralose) sweetener mouth rinse

positive control group (sucrose) 30 participants

Active Comparator group

Treatment:

Dietary Supplement: Sucrose mouth rinse