the Effect of Monk Fruit and Splenda on Salivary Ph and Streptococcus Mutans Count in Vivo Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Monk fruit sweetener mouth rinse, Splenda (sucralose) sweetener mouth rinse, Sucrose mouth rinse.
- Who it may be relevant to
- Registry conditions: Caries Active. Basic parameters: 20 years — 24 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Iraq
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Comparative Evaluation of Monk Fruit and Splenda on Salivary ph and Streptococcus Mutans Growth (an in Vivo Study)
Overview
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.
Interventions
- 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
Primary outcome measures
- salivary ph measurement [Time frame: Baeline salivary ph measurement (before )using mouth rinse , after 1minute , after 15 minutes , and after 30 minutes of mouth rinse]
- Streptococcus mutans count measurement [Time frame: Baseline saliva collection for Streptococcus mutans count and 30 minutes after using mouth rinse saliva collection for Streptococcus mutans count]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Iraq · 1 center
- Almustansiriyah university — Baghdad
Identifiers
NCT: NCT06921434 · Mustansiriyah U