Molar Incisor HypomineralizationASHLTDMCSNCT06330272
Accuracy of Spectrophotometry in Hypomineralized Lesions Treated With CPP-ACPF Dental Mousse: Clinical Study
A study testing Application of dental mousse based on CPP-ACPF in people with Molar Incisor Hypomineralization, run by Meire Coelho Ferreira at 1 site in Brazil.
Trial summary
MIH is a condition with considerable prevalence in the child population. This structural defect, represented by a change in the color of the enamel, can be accompanied by structural loss and great sensitivity. Remineralizing agents have been used to strengthen compromised enamel. Read more about this study
- Who is it for?
- Ages 7 to 9 yearsHealthy volunteers can take part
- Conditions the study is for
- Molar Incisor Hypomineralization
- What is being tested?
- Application of dental mousse based on CPP-ACPF
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 1 siteBrazil
- Study dates
- 15 May 2025to Dec 2026
- 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 7 to 9 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Permanent incisors with mild MIH lesions (marked opacities without structural loss) of at least 2mm in diameter;
- White or beige/yellowish MIH lesions;
- Not present visible bacterial biofilm.
Who cannot join
- Children with enamel malformation associated with syndromes, amelogenesis imperfecta, fluorosis and dental erosion;
- Children allergic to milk proteins (casein).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Accuracy of Spectrophotometry in Determining the Mineralization of Molar-incisor Hypomineralization Lesions by CPP-ACPF Dental Mousse: Clinical Study
MIH is a condition with considerable prevalence in the child population. This structural defect, represented by a change in the color of the enamel, can be accompanied by structural loss and great sensitivity. Remineralizing agents have been used to strengthen compromised enamel. The objective of the study will be to measure the accuracy of a spectrophotometer (VITA Easyshade V) in determining the mineralization of IMH lesions by a CPP-ACPF dental mousse.
Read the detailed description
Molar-incisor hypomineralization (MIH) is a qualitative structural defect of tooth enamel characterized by a marked opacity, asymmetrically involving the first permanent molars and incisors. Some products containing casein phosphopeptide-amorphous calcium phosphate fluoride (CPP-ACPF) have been used in children with MIH. Casein, a protein derived from milk, promotes a remineralizing effect through enzymes present in the oral cavity. The objective of the study will be to evaluate the accuracy of a spectrophotometer (VITA Easyshade V) in the indirect determination of the mineralization of IMH lesions by a dental foam based on CPP-ACPF (Tooth Mousse Plus™). Upper or lower permanent incisors of children aged 7 to 9 years will be included in the study. Two duly calibrated operators will select participants at the Ceuma University Pediatric Dentistry Clinic and the diagnosis of MIH lesions will be carried out using the European Association of Pediatric Dentistry (EAPD) criteria. Inclusion criteria will be permanent incisors with mild MIH lesions (marked opacities without structural loss) of at least 2mm in diameter, white or beige/yellowish in color and that do not present visible bacterial biofilm. Children with enamel malformation associated with syndromes, amelogenesis imperfecta, fluorosis and dental erosion will be excluded; and children allergic to milk proteins (casein). A questionnaire to collect demographic, socioeconomic information and etiological factors for MIH will be administered to parents/guardians. The color of the lesion will be measured before applying the dental foam at baseline and at other follow-up times. It will be measured using the VITA Easyshade V spectrophotometer (Vita Zahnfakrik, Bad Säckingen, Germany). This measurement will be represented by the luminosity parameter (L) and will occur three times on the same tooth to obtain the average values. The change in color (ΔL) of the lesion will be determined from the initial data minus the data after 1 month of evaluation (before the application of dental foam). The visual appearance of the lesion (opaque or shiny appearance) will be assessed initially (opaque lesion for inclusion of the tooth in the research) and further follow-up times (before applying the foam). The lesion will also be assessed tactilely (presence or absence of roughness) prior to the initial treatment and further follow-up times (before applying the foam). The presence of sensitivity will be assessed initially and during follow-up times (before applying the foam) using an air jet. Demographic, socioeconomic and data related to probable etiological factors for MIH will also be collected. The data will be subjected to descriptive and inferential analysis (tests for dependent measures and agreement analysis).
- Conditions
- Molar Incisor Hypomineralization
- Being tested
- Application of dental mousse based on CPP-ACPF
- Keywords
- molar hypomineralization, tooth mousse plus, tooth remineralization, data accuracy
- Medical subject headings
- Molar Hypomineralization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Application of dental mousse based on CPP-ACPFProcedure or surgery
Treatment will begin with pumice prophylaxis of incisors with IMH lesions. After this step, the teeth will be dried before applying dental foam based on CPP-ACPF (Tooth Mousse PlusTM, GC Corporation, Tokyo, Japan).
The application of Tooth Mousse PlusTM to the MIH lesion will be carried out under relative isolation and with the aid of a microbrush. The cream will remain on the surface for 1 minute, which will be timed. The application will be carried out once a week, for four consecutive weeks.
| Study group | Role | What they receive |
|---|---|---|
| CPP-ACPF treatment | Experimental | To apply the dental mousse, prophylaxis will first be carried out on teeth affected by pumice. The application of Tooth Mousse Plus to the MIH lesion will be carried out under relative isolation and with the aid of a microbrush, the amount of mousse will be a "pea grain". The cream will remain on the surface for 1 minute. The application will be carried out once a week, for four consecutive weeks. Receives: Procedure: Application of dental mousse based on CPP-ACPF |
What is being measured
The primary outcome is the main question the study is designed to answer.
To measure the accuracy of a spectrophotometer (VITA Easyshade V) in determining the mineralization of IMH lesions by a CPP-ACPF dental mousse
The spectrophotometry analysis was determined by the Kappa statistic (95% confidence interval) (primary outcome of the study).
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 posted26 Mar 2024
- Study start15 May 2025
- Primary completion15 Dec 2025 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- MIH lesions will receive prophylaxis with pumice stone before application of CPP-ACPF-based dental foam (Tooth Mousse PlusTM, GC Corporation, Tokyo, Japan). The application of Tooth Mousse Plus to the MIH lesion will be carried out under relative isolation and with the aid of a microbrush. The cream will remain on the surface for 1 minute. The application will be carried out once a week, for four consecutive weeks.
- Masking
- None (open label)
- Enrolment
- 98 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meire Coelho Ferreira
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa e Desenvolvimento Científico do Maranhão
- Responsible party
- Sponsor-investigator, Meire Coelho Ferreira, Universidade Ceuma
- Investigators
- Meire C. Ferreira, PhD, Study director, Uniceuma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06330272
- Sponsor's protocol ID
- UCeuma
- Acronym
- ASHLTDMCS
- Status last verified
- May 2025
- First submitted
- 19 Mar 2024
- Last updated
- 21 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Alaluusua S. Aetiology of Molar-Incisor Hypomineralisation: A systematic review. Eur Arch Paediatr Dent. 2010 Apr;11(2):53-8. doi: 10.1007/BF03262713.
PubMed 20403298Altan H, Yilmaz RE. Clinical evaluation of resin infiltration treatment masking effect on hypomineralised enamel surfaces. BMC Oral Health. 2023 Jul 3;23(1):444. doi: 10.1186/s12903-023-03140-6.
PubMed 37400849Americano GC, Jacobsen PE, Soviero VM, Haubek D. A systematic review on the association between molar incisor hypomineralization and dental caries. Int J Paediatr Dent. 2017 Jan;27(1):11-21. doi: 10.1111/ipd.12233. Epub 2016 Apr 21.
PubMed 27098755Aranha AC, Pimenta LA, Marchi GM. Clinical evaluation of desensitizing treatments for cervical dentin hypersensitivity. Braz Oral Res. 2009 Jul-Sep;23(3):333-9. doi: 10.1590/s1806-83242009000300018.
PubMed 19893971Bandeira Lopes L, Machado V, Botelho J, Haubek D. Molar-incisor hypomineralization: an umbrella review. Acta Odontol Scand. 2021 Jul;79(5):359-369. doi: 10.1080/00016357.2020.1863461. Epub 2021 Feb 1.
PubMed 33524270Baroni C, Marchionni S. MIH supplementation strategies: prospective clinical and laboratory trial. J Dent Res. 2011 Mar;90(3):371-6. doi: 10.1177/0022034510388036. Epub 2010 Dec 13.
PubMed 21149856Cardoso-Martins I, Pessanha S, Coelho A, Arantes-Oliveira S, Marques PF. Evaluation of the Efficacy of CPP-ACP Remineralizing Mousse in Molar-Incisor Hypomineralized Teeth Using Polarized Raman and Scanning Electron Microscopy-An In Vitro Study. Biomedicines. 2022 Dec 1;10(12):3086. doi: 10.3390/biomedicines10123086.
PubMed 36551842da Costa-Silva CM, Jeremias F, de Souza JF, Cordeiro Rde C, Santos-Pinto L, Zuanon AC. Molar incisor hypomineralization: prevalence, severity and clinical consequences in Brazilian children. Int J Paediatr Dent. 2010 Nov;20(6):426-34. doi: 10.1111/j.1365-263X.2010.01097.x. Epub 2010 Aug 24.
PubMed 20738434Dias CSCF, Giotto LM, Oliveira Favretto C. O Uso De Vernizes Fluoretados Nos Tratamentos De Hipersensibilidade Dentinária: Uma Abordagem Atual. Rev Saúde Multidiscip. 2022;11(1):20-5
Fagrell TG, Dietz W, Jalevik B, Noren JG. Chemical, mechanical and morphological properties of hypomineralized enamel of permanent first molars. Acta Odontol Scand. 2010 Jul;68(4):215-22. doi: 10.3109/00016351003752395.
PubMed 20392131Bullio Fragelli CM, Jeremias F, Feltrin de Souza J, Paschoal MA, de Cassia Loiola Cordeiro R, Santos-Pinto L. Longitudinal Evaluation of the Structural Integrity of Teeth Affected by Molar Incisor Hypomineralisation. Caries Res. 2015;49(4):378-83. doi: 10.1159/000380858. Epub 2015 May 13.
PubMed 25998233Garot E, Rouas P, Somani C, Taylor GD, Wong F, Lygidakis NA. An update of the aetiological factors involved in molar incisor hypomineralisation (MIH): a systematic review and meta-analysis. Eur Arch Paediatr Dent. 2022 Feb;23(1):23-38. doi: 10.1007/s40368-021-00646-x. Epub 2021 Jun 24.
PubMed 34164793Jalevik B. Prevalence and Diagnosis of Molar-Incisor- Hypomineralisation (MIH): A systematic review. Eur Arch Paediatr Dent. 2010 Apr;11(2):59-64. doi: 10.1007/BF03262714.
PubMed 20403299Kumar A, Goyal A, Gauba K, Kapur A, Singh SK, Mehta SK. An evaluation of remineralised MIH using CPP-ACP and fluoride varnish: An in-situ and in-vitro study. Eur Arch Paediatr Dent. 2022 Feb;23(1):79-87. doi: 10.1007/s40368-021-00630-5. Epub 2021 May 31.
PubMed 34057698Olgen IC, Sonmez H, Bezgin T. Effects of different remineralization agents on MIH defects: a randomized clinical study. Clin Oral Investig. 2022 Mar;26(3):3227-3238. doi: 10.1007/s00784-021-04305-9. Epub 2021 Nov 25.
PubMed 34821978
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy of Spectrophotometry in Determining the Mineralization of Molar-incisor Hypomineralization Lesions by CPP-ACPF Dental Mousse: Clinical Study
- ClinicalTrials.gov ID
- NCT06330272
- Acronym / sponsor ID
- ASHLTDMCS / UCeuma
- Conditions
- Molar Incisor Hypomineralization
- Keywords
- molar hypomineralization, tooth mousse plus, tooth remineralization, data accuracy
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 98 participants (estimated)
- Lead sponsor
- Meire Coelho FerreiraUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa e Desenvolvimento Científico do Maranhão
- Study start
- 15 May 2025 (actual)
- Primary completion
- 15 Dec 2025 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 26 Mar 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.
MIH is a condition with considerable prevalence in the child population. This structural defect, represented by a change in the color of the enamel, can be accompanied by structural loss and great sensitivity. Remineralizing agents have been used to strengthen compromised enamel. The objective of the study will be to measure the accuracy of a spectrophotometer (VITA Easyshade V) in determining the mineralization of IMH lesions by a CPP-ACPF dental mousse.
Detailed description
Molar-incisor hypomineralization (MIH) is a qualitative structural defect of tooth enamel characterized by a marked opacity, asymmetrically involving the first permanent molars and incisors. Some products containing casein phosphopeptide-amorphous calcium phosphate fluoride (CPP-ACPF) have been used in children with MIH. Casein, a protein derived from milk, promotes a remineralizing effect through enzymes present in the oral cavity. The objective of the study will be to evaluate the accuracy of a spectrophotometer (VITA Easyshade V) in the indirect determination of the mineralization of IMH lesions by a dental foam based on CPP-ACPF (Tooth Mousse Plus™). Upper or lower permanent incisors of children aged 7 to 9 years will be included in the study. Two duly calibrated operators will select participants at the Ceuma University Pediatric Dentistry Clinic and the diagnosis of MIH lesions will be carried out using the European Association of Pediatric Dentistry (EAPD) criteria. Inclusion criteria will be permanent incisors with mild MIH lesions (marked opacities without structural loss) of at least 2mm in diameter, white or beige/yellowish in color and that do not present visible bacterial biofilm. Children with enamel malformation associated with syndromes, amelogenesis imperfecta, fluorosis and dental erosion will be excluded; and children allergic to milk proteins (casein). A questionnaire to collect demographic, socioeconomic information and etiological factors for MIH will be administered to parents/guardians. The color of the lesion will be measured before applying the dental foam at baseline and at other follow-up times. It will be measured using the VITA Easyshade V spectrophotometer (Vita Zahnfakrik, Bad Säckingen, Germany). This measurement will be represented by the luminosity parameter (L) and will occur three times on the same tooth to obtain the average values. The change in color (ΔL) of the lesion will be determined from the initial data minus the data after 1 month of evaluation (before the application of dental foam). The visual appearance of the lesion (opaque or shiny appearance) will be assessed initially (opaque lesion for inclusion of the tooth in the research) and further follow-up times (before applying the foam). The lesion will also be assessed tactilely (presence or absence of roughness) prior to the initial treatment and further follow-up times (before applying the foam). The presence of sensitivity will be assessed initially and during follow-up times (before applying the foam) using an air jet. Demographic, socioeconomic and data related to probable etiological factors for MIH will also be collected. The data will be subjected to descriptive and inferential analysis (tests for dependent measures and agreement analysis).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- MIH lesions will receive prophylaxis with pumice stone before application of CPP-ACPF-based dental foam (Tooth Mousse PlusTM, GC Corporation, Tokyo, Japan). The application of Tooth Mousse Plus to the MIH lesion will be carried out under relative isolation and with the aid of a microbrush. The cream will remain on the surface for 1 minute. The application will be carried out once a week, for four consecutive weeks.
| Arm | Type | Receives |
|---|---|---|
| CPP-ACPF treatment | Experimental | Procedure: Application of dental mousse based on CPP-ACPFTo apply the dental mousse, prophylaxis will first be carried out on teeth affected by pumice. The application of Tooth Mousse Plus to the MIH lesion will be carried out under relative isolation and with the aid of a microbrush, the amount of mousse will be a "pea grain". The cream will remain on the surface for 1 minute. The application will be carried out once a week, for four consecutive weeks. |
Who may qualify
- Ages
- 7 to 9 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Permanent incisors with mild MIH lesions (marked opacities without structural loss) of at least 2mm in diameter;
- White or beige/yellowish MIH lesions;
- Not present visible bacterial biofilm.
Key exclusion criteria (2 listed)
- Children with enamel malformation associated with syndromes, amelogenesis imperfecta, fluorosis and dental erosion;
- Children allergic to milk proteins (casein).
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 |
|---|---|---|
| Application of dental mousse based on CPP-ACPFTreatment will begin with pumice prophylaxis of incisors with IMH lesions. After this step, the teeth will be dried before applying dental foam based on CPP-ACPF (Tooth Mousse PlusTM, GC Corporation, Tokyo, Japan). The application of Tooth Mousse PlusTM to the MIH lesion will be carried out under relative isolation and with the aid of a microbrush. The cream will remain on the surface for 1 minute, which will be timed. The application will be carried out once a week, for four consecutive weeks. | Procedure or surgery | CPP-ACPF treatment |
Primary outcome
To measure the accuracy of a spectrophotometer (VITA Easyshade V) in determining the mineralization of IMH lesions by a CPP-ACPF dental mousse
Time frame: 1 month
The spectrophotometry analysis was determined by the Kappa statistic (95% confidence interval) (primary outcome of the study).
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 21 May 2025.
- Background: PubMed 20403298Alaluusua S. Aetiology of Molar-Incisor Hypomineralisation: A systematic review. Eur Arch Paediatr Dent. 2010 Apr;11(2):53-8. doi: 10.1007/BF03262713.
- Background: PubMed 37400849Altan H, Yilmaz RE. Clinical evaluation of resin infiltration treatment masking effect on hypomineralised enamel surfaces. BMC Oral Health. 2023 Jul 3;23(1):444. doi: 10.1186/s12903-023-03140-6.
- Background: PubMed 27098755Americano GC, Jacobsen PE, Soviero VM, Haubek D. A systematic review on the association between molar incisor hypomineralization and dental caries. Int J Paediatr Dent. 2017 Jan;27(1):11-21. doi: 10.1111/ipd.12233. Epub 2016 Apr 21.
- Background: PubMed 19893971Aranha AC, Pimenta LA, Marchi GM. Clinical evaluation of desensitizing treatments for cervical dentin hypersensitivity. Braz Oral Res. 2009 Jul-Sep;23(3):333-9. doi: 10.1590/s1806-83242009000300018.
- Background: PubMed 33524270Bandeira Lopes L, Machado V, Botelho J, Haubek D. Molar-incisor hypomineralization: an umbrella review. Acta Odontol Scand. 2021 Jul;79(5):359-369. doi: 10.1080/00016357.2020.1863461. Epub 2021 Feb 1.
- Background: PubMed 21149856Baroni C, Marchionni S. MIH supplementation strategies: prospective clinical and laboratory trial. J Dent Res. 2011 Mar;90(3):371-6. doi: 10.1177/0022034510388036. Epub 2010 Dec 13.
- Background: PubMed 36551842Cardoso-Martins I, Pessanha S, Coelho A, Arantes-Oliveira S, Marques PF. Evaluation of the Efficacy of CPP-ACP Remineralizing Mousse in Molar-Incisor Hypomineralized Teeth Using Polarized Raman and Scanning Electron Microscopy-An In Vitro Study. Biomedicines. 2022 Dec 1;10(12):3086. doi: 10.3390/biomedicines10123086.
- Background: PubMed 20738434da Costa-Silva CM, Jeremias F, de Souza JF, Cordeiro Rde C, Santos-Pinto L, Zuanon AC. Molar incisor hypomineralization: prevalence, severity and clinical consequences in Brazilian children. Int J Paediatr Dent. 2010 Nov;20(6):426-34. doi: 10.1111/j.1365-263X.2010.01097.x. Epub 2010 Aug 24.
- BackgroundDias CSCF, Giotto LM, Oliveira Favretto C. O Uso De Vernizes Fluoretados Nos Tratamentos De Hipersensibilidade Dentinária: Uma Abordagem Atual. Rev Saúde Multidiscip. 2022;11(1):20-5
- Background: PubMed 20392131Fagrell TG, Dietz W, Jalevik B, Noren JG. Chemical, mechanical and morphological properties of hypomineralized enamel of permanent first molars. Acta Odontol Scand. 2010 Jul;68(4):215-22. doi: 10.3109/00016351003752395.
- Background: PubMed 25998233Bullio Fragelli CM, Jeremias F, Feltrin de Souza J, Paschoal MA, de Cassia Loiola Cordeiro R, Santos-Pinto L. Longitudinal Evaluation of the Structural Integrity of Teeth Affected by Molar Incisor Hypomineralisation. Caries Res. 2015;49(4):378-83. doi: 10.1159/000380858. Epub 2015 May 13.
- Background: PubMed 34164793Garot E, Rouas P, Somani C, Taylor GD, Wong F, Lygidakis NA. An update of the aetiological factors involved in molar incisor hypomineralisation (MIH): a systematic review and meta-analysis. Eur Arch Paediatr Dent. 2022 Feb;23(1):23-38. doi: 10.1007/s40368-021-00646-x. Epub 2021 Jun 24.
- Individual participant dataSharing planned: Undecided
Related trials for Molar Incisor Hypomineralization
Active, not recruiting
Computer-aided Design/Computer-aided Manufacturing for Mild to Moderate Molar Incisor Hypomineralization Treatment
Molar Incisor Hypomineralization
Not yet recruiting
Clinical Performance of Glass Hybrid and Alkasite Restorative Systems in MIH-Affected Permanent First Molars
Molar-Incisor Hypomineralization (MIH)
Recruiting
Nanohydroxyapatite Versus Sodium Fluoride Varnish in Remineralizing MIH Anterior Teeth
Fluoride Varnishes, Molar Incisor Hypomineralisation
Recruiting
Molar-Incisor Hypomineralization and Resin Infiltration
Molar Incisor Hypomineralization
Active, not recruiting
Pain Assessment Governing Partial or Full Pulpotomy of Immature Molars With Irreversible Pulpitis in Molar Incisor Hypomineralization
Molar Incisor Hypomineralisation, Irreversible Pulpitis
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.
Meire C. Ferreira, PhD study director
Uniceuma
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Application of dental mousse based on CPP-ACPF in people with Molar Incisor Hypomineralization, run by Meire Coelho Ferreira at 1 site in Brazil.
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 2 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: under way, not looking for participants, as of the sponsor's last update on 21 May 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 Brazil. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To measure the accuracy of a spectrophotometer (VITA Easyshade V) in determining the mineralization of IMH lesions by a CPP-ACPF dental mousse (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 NCT06330272, which also lists 20 linked publications.
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 21 May 2025.