White Spot LesionNCT05868603
Effect of Different Remineralization Gels
A study testing Remineralization gel in people with White Spot Lesion, run by Marmara University.
Trial summary
The aim of the study is to treat white spot lesions that occur after orthodontic treatment. Different gels will be used for remineralization. The study will consist of 45 people between the ages of 15-18. 45 people will be divided into 3 groups. Read more about this study
- Who is it for?
- Ages 15 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- White Spot Lesion
- What is being tested?
- Remineralization gel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- No sites listed yet
- Study dates
- 24 May 2023to 1 Apr 2025
- 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 15 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Patients aged 15-18 years,
- Presence of white point lesions,
- Volunteering to participate in the research.
Who cannot join
- Not having received orthodontic treatment,
- Having a developmental anomaly affecting the enamel,
- Being allergic to milk,
- Having a syndrome affecting the oral cavity.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effect of Different Remineralization Gels on the White Spot Lesions
The aim of the study is to treat white spot lesions that occur after orthodontic treatment.
Different gels will be used for remineralization. The study will consist of 45 people between the ages of 15-18. 45 people will be divided into 3 groups.
Read the detailed description
Oral hygiene training will be given to each group and a toothpaste containing 1450 ppm fluoride will be given to brush their teeth twice a day.
Essix appliance with reservoir will be made by taking impressions from 30 patients. Remineralization gel will be put into the Essix appliance for 5-7 minutes twice a day for one month.
- Conditions
- White Spot Lesion
- Being tested
- Remineralization gel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remineralization gelOther
Remineralization gel
| Study group | Role | What they receive |
|---|---|---|
| Remineralization gel with CPP- ACP (GC Tooth MousseTM, Tokyo, Japan) | Experimental | CPP-ACP containing remineralization gel (Tooth Mousse GC, Tokyo, Japan) will be put into the Essix appliance with a reservoir and applied for 5-7 minutes twice a day for one month.
Before and after the applying remineralization gel, the laser fluorescence values will measure with a DIAGNOdent pen (KaVo Dental corporation, East Main street Lake Zurich, lL). Receives: Other: Remineralization gel |
| Remineralization gel with calcium glycerophosphate (R.O.C.S.® Medical Mineral Gel, Russia) | Experimental | Remineralization gel containing calcium glycerophosphate (R.O.C.S.® Medical Minerals Gel, Russia) will be put into the Essix appliance with a reservoir for 5-7 minutes twice a day for one month. Before and after the applying remineralization gel, the laser fluorescence values will measure with a DIAGNOdent pen( KaVo Dental corporation, East Main street Lake Zurich, lL). Receives: Other: Remineralization gel |
| Control Group | No intervention | No intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Casein phosphopeptide-amorphous calcium phosphate (CPP-ACP)
Decrease in laser fluorescence values with Diagnodent Pen as an indicator of remineralization
Measured: 4 weeks
Secondary outcomes (1)
Calcium glycerophosphate
Decrease in laser fluorescence values with Diagnodent Pen as an indicator of remineralization
Measured: 4 weeks
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 start24 May 2023 (estimated)
- Primary completion1 Oct 2024 (estimated)
- Study completion1 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for White Spot LesionStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 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
- NCT05868603
- Sponsor's protocol ID
- müdf.24.04.23
- Status last verified
- May 2023
- First submitted
- 24 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
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
- Effect of Different Remineralization Gels on the White Spot Lesions
- ClinicalTrials.gov ID
- NCT05868603
- Acronym / sponsor ID
- müdf.24.04.23
- Conditions
- White Spot Lesion
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 24 May 2023 (estimated)
- Primary completion
- 1 Oct 2024 (estimated)
- Study completion
- 1 Apr 2025 (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 the study is to treat white spot lesions that occur after orthodontic treatment.
Different gels will be used for remineralization. The study will consist of 45 people between the ages of 15-18. 45 people will be divided into 3 groups.
Detailed description
Oral hygiene training will be given to each group and a toothpaste containing 1450 ppm fluoride will be given to brush their teeth twice a day.
Essix appliance with reservoir will be made by taking impressions from 30 patients. Remineralization gel will be put into the Essix appliance for 5-7 minutes twice a day for one month.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Remineralization gel with CPP- ACP (GC Tooth MousseTM, Tokyo, Japan) | Experimental | Other: Remineralization gelCPP-ACP containing remineralization gel (Tooth Mousse GC, Tokyo, Japan) will be put into the Essix appliance with a reservoir and applied for 5-7 minutes twice a day for one month. Before and after the applying remineralization gel, the laser fluorescence values will measure with a DIAGNOdent pen (KaVo Dental corporation, East Main street Lake Zurich, lL). |
| Remineralization gel with calcium glycerophosphate (R.O.C.S.® Medical Mineral Gel, Russia) | Experimental | Other: Remineralization gelRemineralization gel containing calcium glycerophosphate (R.O.C.S.® Medical Minerals Gel, Russia) will be put into the Essix appliance with a reservoir for 5-7 minutes twice a day for one month. Before and after the applying remineralization gel, the laser fluorescence values will measure with a DIAGNOdent pen( KaVo Dental corporation, East Main street Lake Zurich, lL). |
| Control Group | No intervention | –No intervention. |
Who may qualify
- Ages
- 15 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Patients aged 15-18 years,
- Presence of white point lesions,
- Volunteering to participate in the research.
Key exclusion criteria (4 listed)
- Not having received orthodontic treatment,
- Having a developmental anomaly affecting the enamel,
- Being allergic to milk,
- Having a syndrome affecting the oral cavity.
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 |
|---|---|---|
| Remineralization gelRemineralization gel | Other | Remineralization gel with CPP- ACP (GC Tooth MousseTM, Tokyo, Japan), Remineralization gel with calcium glycerophosphate (R.O.C.S.® Medical Mineral Gel, Russia) |
Primary outcome
Casein phosphopeptide-amorphous calcium phosphate (CPP-ACP)
Time frame: 4 weeks
Decrease in laser fluorescence values with Diagnodent Pen as an indicator of remineralization
1 secondary outcome
Calcium glycerophosphate
Time frame: 4 weeks
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.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Remineralization gel in people with White Spot Lesion, 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 3 inclusion and 4 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 Sen Yavuz, DDS (+905399887646, dt.betulsen@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Casein phosphopeptide-amorphous calcium phosphate (CPP-ACP) (time frame: 4 weeks). 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 22 May 2023.