Clinical trial NCT06921434: the Effect of Monk Fruit and Splenda on Salivary Ph and Streptococcus Mutans Count in Vivo Study
Official title: Comparative Evaluation of Monk Fruit and Splenda on Salivary ph and Streptococcus Mutans Growth (an in Vivo Study)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Caries Active
Lead sponsor: Al-Mustansiriyah University
Sponsor class: OTHER
First posted: 2025-04-10
Enrollment: 90
Sex: ALL
Minimum age (years): 20
Maximum age (years): 24
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: salivary ph measurement
timeFrame: Baeline salivary ph measurement (before )using mouth rinse , after 1minute , after 15 minutes , and after 30 minutes of mouth rinse
measure: Streptococcus mutans count measurement
timeFrame: Baseline saliva collection for Streptococcus mutans count and 30 minutes after using mouth rinse saliva collection for Streptococcus mutans count
Secondary outcomes:
Other outcomes:
Locations:
city: Baghdad
country: Iraq
facility: Almustansiriyah university
Study officials:
References: