Dental PlaqueNCT05868590
Evaluation of Toothpaste on Dental Plaque
A study testing Toothpaste in people with Dental Plaque, run by Marmara University.
Trial summary
The aim of this study is to compare the plaque reduction efficacy of toothpaste to a marketed active magnesium toothpaste with single-use brushing in children.Our study will consist of 50 people between the ages of 9-12. 50 people will take part in both toothpaste groups. Read more about this study
- Who is it for?
- Ages 9 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Plaque
- What is being tested?
- Toothpaste
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 26 May 2023to Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 9 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Patients aged 9-12 years
- The presence of caries-free and fully erupted upper anterior incisors that can be scored in the mouth
- Absence of orthodontic appliances/brackets
- No physical limitations
- No previous trauma history
- It was determined as the absence of soft-hard tissue pathology.
Who cannot join
- Patients not between 9-12 years
- The presence of decay and not fully erupted upper anterior incisors that can be scored in the mouth
- Presence of orthodontic appliances/brackets
- Physical limitations
- Previous trauma history
- It was determined as the presence of soft-hard tissue pathology.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Evaluation of Active Magnesium Containing Toothpaste on Dental Plaque in Children
The aim of this study is to compare the plaque reduction efficacy of toothpaste to a marketed active magnesium toothpaste with single-use brushing in children.Our study will consist of 50 people between the ages of 9-12. 50 people will take part in both toothpaste groups.
Read the detailed description
The upper anterior incisor teeth of 50 children will be brushed with two different toothpaste in with a 2 week washout period.At the same time, the GC D lite Pro curing light will determine to differences in the amount of plaque by using detection mode and the differences amount of plaque on teeth will be recorded with using plaque dye.
- Conditions
- Dental Plaque
- Being tested
- Toothpaste
- Medical subject headings
- Dental Plaque
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ToothpasteOther
Using two different toothpastes for removal of the dental plaque in children.
| Study group | Role | What they receive |
|---|---|---|
| Active Magnesium Containing Toothpaste-ROCS | Experimental | The participants will ask not to eat for 4 hours and not to brush for 24 hours in advance of the test.In the first stage, the preliminary plaque in the children will record by the first researcher using plaque dye.After plaque disclosing the researcher brush children's teeth with ROCS active magnesium toothpaste for 1 minute with a standard toothbrush then the plaque staining will apply again.Also remaining plaque measurements will made using the Gc D lite Pro curring light on detection mode.Dental plaque on the upper anterior incisors will photograph intra-orally before and after brushing under standardized conditions. Receives: Other: Toothpaste |
| Fluoride Toothpaste-COLGATE | Experimental | After 2 weeks, the same participants will ask not to eat for 4 hours and not to brush for 24 hours in advance of the retest.Initial, the preliminary plaque in the children will record by the first researcher using plaque dye. After plaque disclosing the researcher brush children's teeth with Colgate fluoride toothpaste for 1 minute with a standard toothbrush then the plaque staining will apply again.Also remaining plaque measurements will made using the Gc D lite Pro curring light on detection mode.Dental plaque on the upper anterior incisors will photograph intra-orally before and after brushing under standardized conditions. Receives: Other: Toothpaste |
What is being measured
The primary outcome is the main question the study is designed to answer.
Active Magnesium Containing Toothpaste (ROCS)
Active magnesium containing toothpaste can find to be effective in reducing plaque of Turesky-Modified Quinley-Hein-Plaque-Index (TMQHPI) score when compare to Fluoride toothpaste with single-use brushing in children
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2023
- Study start26 May 2023 (estimated)
- Primary completion26 Jan 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dental PlaqueStudies of the same condition, open and under way.
- More trials run by Marmara UniversityThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Haner Direskeneli, Marmara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05868590
- Sponsor's protocol ID
- 2022/37
- Status last verified
- May 2023
- First submitted
- 26 Apr 2023
- Last updated
- 22 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dokumacigil NK, Yavuz BS, Sivet EA, Kargul B. Clinical and Digital Imaging Assessment of Dental Plaque With Two Different Toothpastes in Children: A Randomized Crossover Clinical Trial. Int J Dent Hyg. 2026 Jun 25. doi: 10.1111/idh.70123. Online ahead of print.
PubMed 42357830
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Active Magnesium Containing Toothpaste on Dental Plaque in Children
- ClinicalTrials.gov ID
- NCT05868590
- Acronym / sponsor ID
- 2022/37
- Conditions
- Dental Plaque
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 26 May 2023 (estimated)
- Primary completion
- 26 Jan 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 22 May 2023 (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.
The aim of this study is to compare the plaque reduction efficacy of toothpaste to a marketed active magnesium toothpaste with single-use brushing in children.Our study will consist of 50 people between the ages of 9-12. 50 people will take part in both toothpaste groups.
Detailed description
The upper anterior incisor teeth of 50 children will be brushed with two different toothpaste in with a 2 week washout period.At the same time, the GC D lite Pro curing light will determine to differences in the amount of plaque by using detection mode and the differences amount of plaque on teeth will be recorded with using plaque dye.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Magnesium Containing Toothpaste-ROCS | Experimental | Other: ToothpasteThe participants will ask not to eat for 4 hours and not to brush for 24 hours in advance of the test.In the first stage, the preliminary plaque in the children will record by the first researcher using plaque dye.After plaque disclosing the researcher brush children's teeth with ROCS active magnesium toothpaste for 1 minute with a standard toothbrush then the plaque staining will apply again.Also remaining plaque measurements will made using the Gc D lite Pro curring light on detection mode.Dental plaque on the upper anterior incisors will photograph intra-orally before and after brushing under standardized conditions. |
| Fluoride Toothpaste-COLGATE | Experimental | Other: ToothpasteAfter 2 weeks, the same participants will ask not to eat for 4 hours and not to brush for 24 hours in advance of the retest.Initial, the preliminary plaque in the children will record by the first researcher using plaque dye. After plaque disclosing the researcher brush children's teeth with Colgate fluoride toothpaste for 1 minute with a standard toothbrush then the plaque staining will apply again.Also remaining plaque measurements will made using the Gc D lite Pro curring light on detection mode.Dental plaque on the upper anterior incisors will photograph intra-orally before and after brushing under standardized conditions. |
Who may qualify
- Ages
- 9 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Patients aged 9-12 years
- The presence of caries-free and fully erupted upper anterior incisors that can be scored in the mouth
- Absence of orthodontic appliances/brackets
- No physical limitations
- No previous trauma history
Key exclusion criteria (6 listed)
- Patients not between 9-12 years
- The presence of decay and not fully erupted upper anterior incisors that can be scored in the mouth
- Presence of orthodontic appliances/brackets
- Physical limitations
- Previous trauma history
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 |
|---|---|---|
| ToothpasteUsing two different toothpastes for removal of the dental plaque in children. | Other | Active Magnesium Containing Toothpaste-ROCS, Fluoride Toothpaste-COLGATE |
Primary outcome
Active Magnesium Containing Toothpaste (ROCS)
Time frame: 1 month
Active magnesium containing toothpaste can find to be effective in reducing plaque of Turesky-Modified Quinley-Hein-Plaque-Index (TMQHPI) score when compare to Fluoride toothpaste with single-use brushing in children
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2023.
- Derived from this study: PubMed 42357830Dokumacigil NK, Yavuz BS, Sivet EA, Kargul B. Clinical and Digital Imaging Assessment of Dental Plaque With Two Different Toothpastes in Children: A Randomized Crossover Clinical Trial. Int J Dent Hyg. 2026 Jun 25. doi: 10.1111/idh.70123. Online ahead of print.
- Individual participant dataSharing planned: No
Related trials for Dental Plaque
Not yet recruiting
Effect of Xylitol- Versus Erythritol-Sweetened Mints on Plaque ATP-Bioluminescence Readings
Dental Caries, Dental Plaque
Not yet recruitingObservational study
Plaque and Bleeding on Probing Around Implants Supporting Fixed Full-Arch Dental Prostheses
Peri-Implant Health
Not yet recruiting
Effectiveness of Oil Pulling Using Oils in Comparison With Mouthwash for Gingivitis
Gingivitis
Recruiting
The Study to Evaluate the Plaque Control and Anti-Gingivitis Efficacy of a Toothpaste in Chinese Population
Dental Plaque, Gingivitis
Not yet recruiting
Individualized Management of Plaque-Related Gingival Inflammation in Routine Dental Practice
Plaque-Induced Gingivitis
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. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Toothpaste in people with Dental Plaque, run by Marmara University.
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 6 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 22 May 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Betul Kargul, Prof.Dr. (+905323267207, bkargul@marmara.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Active Magnesium Containing Toothpaste (ROCS) (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05868590, which also lists 1 linked publication.
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 22 May 2023.