Caries ActiveNCT06921434
the Effect of Monk Fruit and Splenda on Salivary Ph and Streptococcus Mutans Count in Vivo Study
A study testing Monk fruit sweetener mouth rinse, Splenda (sucralose) sweetener mouth rinse and Sucrose mouth rinse in people with Caries Active, run by Al-Mustansiriyah University at 1 site in Iraq.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 24 yearsHealthy volunteers can take part
- Conditions the study is for
- Caries Active
- What is being tested?
- Monk fruit sweetener mouth rinse, Splenda (sucralose) sweetener mouth rinse and Sucrose mouth rinse
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteIraq
- Study dates
- 1 Oct 2025to 1 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 24 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Comparative Evaluation of Monk Fruit and Splenda on Salivary ph and Streptococcus Mutans Growth (an in Vivo Study)
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.
Read the 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
- Being tested
- Monk fruit sweetener mouth rinse, Splenda (sucralose) sweetener mouth rinse, Sucrose mouth rinse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Monk fruit sweetener mouth rinseDietary supplement
monk fruit mouth rinse 10 grams of sweetener powder and 90 ml of distilled water for 30 participants for 1 minute
Splenda (sucralose) sweetener mouth rinseDietary supplement
10 g of splenda powder with 90 ml of distilled water for 30 participants for 1 minute
Sucrose mouth rinseDietary supplement
10 g of sucrose powder dissolved in 90 ml of distilled water as a positive control group for 30 participants for 1 minute
| Study group | Role | What they receive |
|---|---|---|
| monk fruit sweetener group 30 participants | Experimental | Not described Receives: Dietary Supplement: Monk fruit sweetener mouth rinse |
| Splenda (sucralose) sweetener group 30 participants | Experimental | Not described Receives: Dietary Supplement: Splenda (sucralose) sweetener mouth rinse |
| positive control group (sucrose) 30 participants | Active comparator | Not described Receives: Dietary Supplement: Sucrose mouth rinse |
What is being measured
The primary outcome is the main question the study is designed to answer.
salivary ph measurement
the salivary ph will measure quantitatively using a ph meter
Measured: Baeline salivary ph measurement (before )using mouth rinse , after 1minute , after 15 minutes , and after 30 minutes of mouth rinse
Streptococcus mutans count measurement
streptococcus mutans count before mouth rinsing ,and after 30 minutes to evaluate the count if it increase or decrease
Measured: Baseline saliva collection for Streptococcus mutans count and 30 minutes after using mouth rinse saliva collection for Streptococcus mutans count
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2025
- Study start1 Oct 2025 (estimated)
- Primary completion1 Nov 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Caries ActiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Al-Mustansiriyah University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kawthar Salman Alharan, Al-Mustansiriyah University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06921434
- Sponsor's protocol ID
- Mustansiriyah U
- Status last verified
- Sep 2025
- First submitted
- 1 Apr 2025
- Last updated
- 24 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Evaluation of Monk Fruit and Splenda on Salivary ph and Streptococcus Mutans Growth (an in Vivo Study)
- ClinicalTrials.gov ID
- NCT06921434
- Acronym / sponsor ID
- Mustansiriyah U
- Conditions
- Caries Active
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Al-Mustansiriyah UniversityUniversity, hospital or other
- Study start
- 1 Oct 2025 (estimated)
- Primary completion
- 1 Nov 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 10 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- 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
| Arm | Type | Receives |
|---|---|---|
| monk fruit sweetener group 30 participants | Experimental | Dietary Supplement: Monk fruit sweetener mouth rinse |
| Splenda (sucralose) sweetener group 30 participants | Experimental | Dietary Supplement: Splenda (sucralose) sweetener mouth rinse |
| positive control group (sucrose) 30 participants | Active comparator | Dietary Supplement: Sucrose mouth rinse |
Who may qualify
- Ages
- 20 to 24 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Participants currently undergoing dental treatment.
- Those taking medications that alter saliva flow.
- Presence of painful oral conditions or systemic diseases. Participants have active caries
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Monk fruit sweetener mouth rinsemonk fruit mouth rinse 10 grams of sweetener powder and 90 ml of distilled water for 30 participants for 1 minute | Dietary supplement | monk fruit sweetener group 30 participants |
| Splenda (sucralose) sweetener mouth rinse10 g of splenda powder with 90 ml of distilled water for 30 participants for 1 minute | Dietary supplement | Splenda (sucralose) sweetener group 30 participants |
| Sucrose mouth rinse10 g of sucrose powder dissolved in 90 ml of distilled water as a positive control group for 30 participants for 1 minute | Dietary supplement | positive control group (sucrose) 30 participants |
Primary outcome
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
the salivary ph will measure quantitatively using a ph meter
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
streptococcus mutans count before mouth rinsing ,and after 30 minutes to evaluate the count if it increase or decrease
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Monk fruit sweetener mouth rinse, Splenda (sucralose) sweetener mouth rinse and Sucrose mouth rinse in people with Caries Active, run by Al-Mustansiriyah University at 1 site in Iraq.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iraq. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kawthar Salman Alharan, B.D.S (009647742276207, kawtharalharran@uomustansiriyah.edu.iq), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2025.