Ignite Creation Date:
2025-12-25 @ 2:27 AM
Ignite Modification Date:
2025-12-30 @ 1:41 AM
Study NCT ID:
NCT06921434
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-09-24
First Post:
2025-04-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
the Effect of Monk Fruit and Splenda on Salivary Ph and Streptococcus Mutans Count in Vivo Study
Sponsor:
Al-Mustansiriyah University
Organization:
Study Overview
Official Title:
Comparative Evaluation of Monk Fruit and Splenda on Salivary ph and Streptococcus Mutans Growth (an in Vivo Study)
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: