Molar Incisor HypomineralizationNCT06362681
Effects of Different Remineralization Agents on Molar Incisor Hypomineralization Defects: a Randomized Clinical Study
A study testing Fluoride in people with Molar Incisor Hypomineralization, run by Universidad Nacional Autonoma de Mexico at 1 site in Mexico.
Trial summary
The aim of this study was to present a comparative evaluation of the long-term efficacy of fluoride varnish( Flúor protector), Clinpro™ White Varnish and pastes containing CPP-ACP in the remineralization of creamy-white and yellow brown defects in incisors and permanent first molars with Molar Incisor… Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Molar Incisor Hypomineralization
- What is being tested?
- Fluoride
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteMexico
- Study dates
- 1 Mar 2024to 30 Mar 2026
- 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 6 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children between 6 to 12 years
- They live in the selected study area
- Have at least one permanent incisor or molar with mild or moderate MIH (creamy white and/or yellow or brown opacities)
- That their parents authorize participation in the study through informed consent.
- No proven or suspected allergy and/or sensitivity to milk protein, as it is a component of the CPP-ACP product.
Who cannot join
- Defects in enamel development related to syndromes, dental fluorosis, amelogenesis imperfecta, dentinogenesis imperfecta.
- Presence of orthodontic appliances.
- Teeth with MIH with restorations, or severe MIH (affected enamel develops post-eruptive enamel breakdown), or carious lesions classified as score >0 according to the ICDAS.
- Children who do not show cooperation in the use of remineralizing agents.
Trial locations and contacts
1 site in 1 country.
Mexico1 site, 1 recruiting
- Recruiting
Alvaro Garcia Pérez
San Pedro Apatlaco, Morelos
About this study
Official title: Randomized Clinical Trial to Evaluate the Effectiveness of Three Remineralizing Agents on Mineral Density in Permanent Teeth and Molars With Molar Incisor Hypomineralization
The aim of this study was to present a comparative evaluation of the long-term efficacy of fluoride varnish( Flúor protector), Clinpro™ White Varnish and pastes containing CPP-ACP in the remineralization of creamy-white and yellow brown defects in incisors and permanent first molars with Molar Incisor Hypomineralization (MIH) in schoolchildren 6-12 years-old in Mexico.
Read the detailed description
The study included 208 teeth with yellow-brown or creamy-white defects in children aged 6-12 years who were newly diagnosed with MIH with no substance loss or caries or prior restorative treatment. The children will be randomly divided into the experiment groups: control (oral hygiene motivation only), fluoride varnish, clinpro white Varnish and pastes containing CPP-ACP and followed up for 24 months. The evaluations will be made based on the ICDAS criteria and the measurements which were performed using the laser fluorescence method (DIAGNOdent, KaVo, Biberach, Germany) in the follow-ups.
- Conditions
- Molar Incisor Hypomineralization
- Being tested
- Fluoride
- Keywords
- Molar Incisor Hypomineralization
- Medical subject headings
- Molar Hypomineralization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FluorideOther
Also called Casein phosphopeptide-amorphous calcium phosphate, Fluor protector, Clinpro White Varnish
Application of remineralizing agents on teeth and molars with MIH during 24 months of follow-up.
| Study group | Role | What they receive |
|---|---|---|
| Group I: control (oral hygiene motivation only), | No intervention | Participants will be advised to brush their teeth and enamel surfaces three times a day with a 1000 ppm fluoride toothpaste (stabilized Tin Fluoride), for which a 75ml/102g tube will be provided to each participant each time. months to ensure compliance and uniformity. |
| Group II: fluoride varnish (Flúor Protector Ivoclar Vivadent) | Experimental | The selected participants will have the fluoride varnish applied once a month for the 24 months of the study. The varnish will only be applied to the teeth and molars with HIM. Receives: Other: Fluoride |
| Group III: fluoride varnish (Clinpro White Varnish 3M ESPE) | Experimental | The selected participants will have the fluoride varnish applied once a month for the 24 months of the study. The varnish will only be applied to the teeth and molars with HIM. Receives: Other: Fluoride |
| Group IV: CPP-ACP | Experimental | Participants will make a single daily application of 0.3 g of CPP-ACP cream (GC America, MI Paste™ Recaldent®) on the enamel surface. This will be done for 24 months, at night, to maintain prolonged contact of this agent with the surface of the tooth. The night time schedule is chosen because the longer the time in which both CPP-ACP and saliva are kept in the mouth, the more effective the result will be. A measuring spoon will be given to each participant to ensure standardized delivery of 0.3 g of CPP-ACP to each participant's enamel surface. Receives: Other: Fluoride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mineral Density
evaluate and compare variations in mineral density (MD) using laser induced fluorescence (LF) after applying Fluoride Varnish, Clinpro or Casein phosphopeptide amorphous calcium phosphate on teeth with Molar Incisor Hypomineralization (MIH).
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2024
- Study start1 Mar 2024
- Primary completion30 Jun 2024 (estimated)
- Study completion30 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Molar Incisor HypomineralizationStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- The children will be randomly divided into the experiment groups: control (oral hygiene motivation only), fluoride varnish, clinpro white Varnish and pastes containing CPP-ACP and followed up for 24 months.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Nacional Autonoma de Mexico
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alvaro García Perez, Universidad Nacional Autonoma de Mexico
- Investigators
- Alvaro Garcia Pérez, PhD, Principal investigator, Universidad Nacional Autonoma de Mexico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06362681
- Sponsor's protocol ID
- CF-2023-I-13
- Status last verified
- Apr 2024
- First submitted
- 8 Apr 2024
- Last updated
- 12 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data supporting the findings of this study will be available upon request to the principal investigator of the study.
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial to Evaluate the Effectiveness of Three Remineralizing Agents on Mineral Density in Permanent Teeth and Molars With Molar Incisor Hypomineralization
- ClinicalTrials.gov ID
- NCT06362681
- Acronym / sponsor ID
- CF-2023-I-13
- Conditions
- Molar Incisor Hypomineralization
- Keywords
- Molar Incisor Hypomineralization
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Universidad Nacional Autonoma de MexicoUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 30 Mar 2026 (estimated)
- First posted
- 12 Apr 2024 (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 was to present a comparative evaluation of the long-term efficacy of fluoride varnish( Flúor protector), Clinpro™ White Varnish and pastes containing CPP-ACP in the remineralization of creamy-white and yellow brown defects in incisors and permanent first molars with Molar Incisor Hypomineralization (MIH) in schoolchildren 6-12 years-old in Mexico.
Detailed description
The study included 208 teeth with yellow-brown or creamy-white defects in children aged 6-12 years who were newly diagnosed with MIH with no substance loss or caries or prior restorative treatment. The children will be randomly divided into the experiment groups: control (oral hygiene motivation only), fluoride varnish, clinpro white Varnish and pastes containing CPP-ACP and followed up for 24 months. The evaluations will be made based on the ICDAS criteria and the measurements which were performed using the laser fluorescence method (DIAGNOdent, KaVo, Biberach, Germany) in the follow-ups.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- The children will be randomly divided into the experiment groups: control (oral hygiene motivation only), fluoride varnish, clinpro white Varnish and pastes containing CPP-ACP and followed up for 24 months.
| Arm | Type | Receives |
|---|---|---|
| Group I: control (oral hygiene motivation only), | No intervention | –Participants will be advised to brush their teeth and enamel surfaces three times a day with a 1000 ppm fluoride toothpaste (stabilized Tin Fluoride), for which a 75ml/102g tube will be provided to each participant each time. months to ensure compliance and uniformity. |
| Group II: fluoride varnish (Flúor Protector Ivoclar Vivadent) | Experimental | Other: FluorideThe selected participants will have the fluoride varnish applied once a month for the 24 months of the study. The varnish will only be applied to the teeth and molars with HIM. |
| Group III: fluoride varnish (Clinpro White Varnish 3M ESPE) | Experimental | Other: FluorideThe selected participants will have the fluoride varnish applied once a month for the 24 months of the study. The varnish will only be applied to the teeth and molars with HIM. |
| Group IV: CPP-ACP | Experimental | Other: FluorideParticipants will make a single daily application of 0.3 g of CPP-ACP cream (GC America, MI Paste™ Recaldent®) on the enamel surface. This will be done for 24 months, at night, to maintain prolonged contact of this agent with the surface of the tooth. The night time schedule is chosen because the longer the time in which both CPP-ACP and saliva are kept in the mouth, the more effective the result will be. A measuring spoon will be given to each participant to ensure standardized delivery of 0.3 g of CPP-ACP to each participant's enamel surface. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Children between 6 to 12 years
- They live in the selected study area
- Have at least one permanent incisor or molar with mild or moderate MIH (creamy white and/or yellow or brown opacities)
- That their parents authorize participation in the study through informed consent.
- No proven or suspected allergy and/or sensitivity to milk protein, as it is a component of the CPP-ACP product.
Key exclusion criteria (4 listed)
- Defects in enamel development related to syndromes, dental fluorosis, amelogenesis imperfecta, dentinogenesis imperfecta.
- Presence of orthodontic appliances.
- Teeth with MIH with restorations, or severe MIH (affected enamel develops post-eruptive enamel breakdown), or carious lesions classified as score >0 according to the ICDAS.
- Children who do not show cooperation in the use of remineralizing agents.
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 |
|---|---|---|
| FluorideAlso: Casein phosphopeptide-amorphous calcium phosphate, Fluor protector, Clinpro White VarnishApplication of remineralizing agents on teeth and molars with MIH during 24 months of follow-up. | Other | Group II: fluoride varnish (Flúor Protector Ivoclar Vivadent), Group III: fluoride varnish (Clinpro White Varnish 3M ESPE), Group IV: CPP-ACP |
Primary outcome
Mineral Density
Time frame: 24 months
evaluate and compare variations in mineral density (MD) using laser induced fluorescence (LF) after applying Fluoride Varnish, Clinpro or Casein phosphopeptide amorphous calcium phosphate on teeth with Molar Incisor Hypomineralization (MIH).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2024.
- Individual participant dataSharing planned: Undecided. Data supporting the findings of this study will be available upon request to the principal investigator of the study.
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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.
Alvaro Garcia Pérez, PhD principal investigator
Universidad Nacional Autonoma de Mexico
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fluoride in people with Molar Incisor Hypomineralization, run by Universidad Nacional Autonoma de Mexico at 1 site in Mexico.
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 5 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 12 Apr 2024. 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 Mexico. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alvaro Garcia Pérez, PhD (+525525351374, alvaro.garcia@unam.mx), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mineral Density (time frame: 24 months). 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 12 Apr 2024.