NCT06921434

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

Comparative Evaluation of Monk Fruit and Splenda on Salivary ph and Streptococcus Mutans Growth (an in Vivo Study)

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Al-Mustansiriyah University · Academic / Other
• Sex: All
• Age: 20 Years – 24 Years
• Healthy volunteers: Accepted

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.

Conditions

• Caries Active

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	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
DIETARY_SUPPLEMENT	Splenda (sucralose) sweetener mouth rinse	10 g of splenda powder with 90 ml of distilled water for 30 participants for 1 minute
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

Timeline

• Start date: 2025-10-01
• Primary completion: 2025-11-01
• Completion: 2025-12-01
• First posted: 2025-04-10
• Last updated: 2025-09-24

Locations

1 site across 1 country: Iraq