Molar Incisor HypomineralizationECLIPSENCT07653373
Effect of Enamel Cleaning on a Remineralizing Paste for Hypomineralizated Lesions
A study testing Sodium hypochlorite 5.25% and CPP-ACPF in people with Molar Incisor Hypomineralization, run by Universidade Ceuma at 1 site in Brazil.
Trial summary
Molar-incisor hypomineralization (MIH) is a qualitative defect of dental enamel, in which low mineral content and high protein content compromise the effectiveness of remineralizing treatments. Various agents have been used to remove proteins from hypomineralized enamel, such as sodium hypochlorite (NaOCl). 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?
- Sodium hypochlorite 5.25% and CPP-ACPF
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteBrazil
- Study dates
- Aug 2026to Apr 2028
- 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
- Children with at least one permanent molar without MIH.
- At least two permanent molars with mild MIH lesions (demarcated opacities without structural loss)
- Lesions may be with or without sensitivity
- Lesions cream-white or yellowish in color
- Lesions ≥ 2 mm in diameter
- Lesions may be on the same or different dental arches
Who cannot join
- Visible bacterial biofilm
- Enamel malformations associated with syndromes
- Amelogenesis imperfecta
- Fluorosis
- Allergy to milk proteins (casein)
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: The Effect Of Deproteinization On The Performance Of CPP-ACPF On Hypomineralized Enamel: A Clinical Evaluation
Molar-incisor hypomineralization (MIH) is a qualitative defect of dental enamel, in which low mineral content and high protein content compromise the effectiveness of remineralizing treatments. Various agents have been used to remove proteins from hypomineralized enamel, such as sodium hypochlorite (NaOCl). Sodium hypochlorite is an antimicrobial irrigant capable of dissolving tissues. The amorphous calcium fluoride casein phosphate phosphopeptide (CPP-ACPF) is used as a remineralizing agent for MIH lesions, it is capable of stabilizing calcium, phosphate, and fluoride ions on the tooth surface, maintaining them in an amorphous form. Therefore, the objective of this study is to evaluate the clinical performance of CPP-ACPF dental mousse on deproteinized hypomineralized enamel.
Read the detailed description
MIH is characterized by a marked opacity, asymmetrically involving the first permanent molars and incisors. In more severe cases of MIH, in addition to the retention of matrix proteins that should have been removed during the enamel maturation process, its more porous structure allows the penetration of proteins present in saliva, which bind to the poorly developed hydroxyapatite crystals. The high protein content of enamel with MIH also promotes the growth of proteolytic bacteria, posing a challenge for the adhesion of restorative materials and treatments for hypersensitivity. Some products containing CPP-ACPF have been used in children with MIH, it can stabilize calcium, phosphate, and fluoride ions on the tooth surface. Given that MIH lesions have a high protein content that may prevent the mineralizing agent from reaching the underdeveloped enamel prisms, it is expected that treatment with CPP-ACPF will be more effective following prior deproteinization of the affected enamel. A double-blind, split-mouth, randomized clinical trial will be conducted. The teeth included in the study will be permanent upper or lower molars with MIH in children aged 7 to 9 years. Two properly calibrated examiners will select the participants, and the diagnosis of MIH lesions will be based on the criteria of the European Association of Paediatric Dentistry (EAPD). The inclusion criteria will be: one permanent molar without MIH; at least two permanent molars with mild MIH lesions (demarcated opacities without structural loss), with or without sensitivity, of a cream-white or yellowish color, and 2 mm in diameter; and without visible bacterial biofilm. The selected teeth from each participant will be divided into 3 groups: Control Group (molars without hypomineralization); CPP-ACPF Group (hypomineralized molars treated with CPP-ACPF); and NaOCl/CPP-ACPF Group (hypomineralized molars deproteinized with 5.25% NaOCl, with application time based on laboratory study findings, and treated with CPP-ACPF). The randomization of treatments for hypomineralized teeth will be performed at the time of treatment. The following data collection tools will be used: a questionnaire to collect demographic and socioeconomic information, as well as information on etiological factors for MIH; clinical examination to assess the following aspects of the lesions: location (occlusal or middle third), lesion area (in mm²), color (cream-white or yellowish), visual appearance (shiny or opaque), sensitivity, and lightness of the lesion color (L). The tooth's L will be measured three times to obtain the average of the values. The data will be analyzed descriptively and inferentially. Clinical analyses will include intragroup comparisons (between follow-up times) and intergroup comparisons (between group outcomes), at a 5% significance level.
- Conditions
- Molar Incisor Hypomineralization
- Being tested
- Sodium hypochlorite 5.25%, CPP-ACPF
- Keywords
- molar hypomineralization, dental enamel, spectrophotometry, dental remineralization
- Medical subject headings
- Molar Hypomineralization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium hypochlorite 5.25%Drug
Also called NaOCL
Sodium hypochlorite is a proteolytic substance that interferes with the cellular metabolism of proteins.
CPP-ACPFDrug
Also called Amorphous calcium fluoride casein phosphate phosphopeptide
Casein is a milk-derived protein that, during enzymatic digestion in the mouth, is converted into a casein phosphopeptide (CPP) molecule. CPP is capable of stabilizing calcium, phosphate, and fluoride ions on the tooth surface, keeping them in an amorphous form. Thus, CPP-ACPF functions as a reservoir of calcium phosphate.
| Study group | Role | What they receive |
|---|---|---|
| Control Group (molars without hypomineralization) | No intervention | Health molars without hypomineralization |
| CPP-ACPF in hypomineralized molars | Experimental | Hypomineralized molars treated with CPP-ACPF, without prior deproteinization. (Treatment will be administered once a week for 4 consecutive weeks). Receives: Drug: CPP-ACPF |
| Sodium hypochlorite 5.25%/CPP-ACPF Group | Experimental | Hypomineralized molars treated with CPP-ACPF, with preliminary deproteinization (Treatment will be administered once a week for 4 consecutive weeks) Receives: Drug: Sodium hypochlorite 5.25%; Drug: CPP-ACPF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mineralization of MIH lesions
The measurements will be taken using a spectrophotometer (Vita Easyshade) to assess tooth brightness before and after treatment
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 posted17 Jun 2026
- Study startAug 2026 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionApr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)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
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade Ceuma
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa e Desenvolvimento Científico do Maranhão
- Responsible party
- Principal investigator, Meire Coelho Ferreira, Universidade Ceuma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07653373
- Sponsor's protocol ID
- UnCeuma
- Acronym
- ECLIPSE
- Status last verified
- Jul 2026
- First submitted
- 11 Jun 2026
- Last updated
- 8 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sonmez H, Saat S. A Clinical Evaluation of Deproteinization and Different Cavity Designs on Resin Restoration Performance in MIH-Affected Molars: Two-Year Results. J Clin Pediatr Dent. 2017;41(5):336-342. doi: 10.17796/1053-4628-41.5.336.
PubMed 28872993Mangum JE, Crombie FA, Kilpatrick N, Manton DJ, Hubbard MJ. Surface integrity governs the proteome of hypomineralized enamel. J Dent Res. 2010 Oct;89(10):1160-5. doi: 10.1177/0022034510375824. Epub 2010 Jul 22.
PubMed 20651090Mahoney E, Ismail FS, Kilpatrick N, Swain M. Mechanical properties across hypomineralized/hypoplastic enamel of first permanent molar teeth. Eur J Oral Sci. 2004 Dec;112(6):497-502. doi: 10.1111/j.1600-0722.2004.00162.x.
PubMed 15560832Gandhi S, Crawford P, Shellis P. The use of a 'bleach-etch-seal' deproteinization technique on MIH affected enamel. Int J Paediatr Dent. 2012 Nov;22(6):427-34. doi: 10.1111/j.1365-263X.2011.01212.x. Epub 2012 Jan 18.
PubMed 22251382Bullio 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 25998233Fagrell 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 20392131Elhennawy K, Manton DJ, Crombie F, Zaslansky P, Radlanski RJ, Jost-Brinkmann PG, Schwendicke F. Structural, mechanical and chemical evaluation of molar-incisor hypomineralization-affected enamel: A systematic review. Arch Oral Biol. 2017 Nov;83:272-281. doi: 10.1016/j.archoralbio.2017.08.008. Epub 2017 Aug 19.
PubMed 28843745Crombie FA, Cochrane NJ, Manton DJ, Palamara JE, Reynolds EC. Mineralisation of developmentally hypomineralised human enamel in vitro. Caries Res. 2013;47(3):259-63. doi: 10.1159/000346134. Epub 2013 Jan 29.
PubMed 23363890Americano 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 27098755Amend S, Stork S, Lucker S, Seipp A, Gartner U, Frankenberger R, Kramer N. Influence of different pre-treatments on the resin infiltration depth into enamel of teeth affected by molar-incisor hypomineralization (MIH). Dent Mater. 2024 Jul;40(7):1015-1024. doi: 10.1016/j.dental.2024.05.010. Epub 2024 May 13.
PubMed 38744567Altan 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 37400849Olgen 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 34821978Kumar 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 34057698
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect Of Deproteinization On The Performance Of CPP-ACPF On Hypomineralized Enamel: A Clinical Evaluation
- ClinicalTrials.gov ID
- NCT07653373
- Acronym / sponsor ID
- ECLIPSE / UnCeuma
- Conditions
- Molar Incisor Hypomineralization
- Keywords
- molar hypomineralization, dental enamel, spectrophotometry, dental remineralization
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Universidade CeumaUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa e Desenvolvimento Científico do Maranhão
- Study start
- Aug 2026 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Apr 2028 (estimated)
- First posted
- 17 Jun 2026 (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.
Molar-incisor hypomineralization (MIH) is a qualitative defect of dental enamel, in which low mineral content and high protein content compromise the effectiveness of remineralizing treatments. Various agents have been used to remove proteins from hypomineralized enamel, such as sodium hypochlorite (NaOCl). Sodium hypochlorite is an antimicrobial irrigant capable of dissolving tissues. The amorphous calcium fluoride casein phosphate phosphopeptide (CPP-ACPF) is used as a remineralizing agent for MIH lesions, it is capable of stabilizing calcium, phosphate, and fluoride ions on the tooth surface, maintaining them in an amorphous form. Therefore, the objective of this study is to evaluate the clinical performance of CPP-ACPF dental mousse on deproteinized hypomineralized enamel.
Detailed description
MIH is characterized by a marked opacity, asymmetrically involving the first permanent molars and incisors. In more severe cases of MIH, in addition to the retention of matrix proteins that should have been removed during the enamel maturation process, its more porous structure allows the penetration of proteins present in saliva, which bind to the poorly developed hydroxyapatite crystals. The high protein content of enamel with MIH also promotes the growth of proteolytic bacteria, posing a challenge for the adhesion of restorative materials and treatments for hypersensitivity. Some products containing CPP-ACPF have been used in children with MIH, it can stabilize calcium, phosphate, and fluoride ions on the tooth surface. Given that MIH lesions have a high protein content that may prevent the mineralizing agent from reaching the underdeveloped enamel prisms, it is expected that treatment with CPP-ACPF will be more effective following prior deproteinization of the affected enamel. A double-blind, split-mouth, randomized clinical trial will be conducted. The teeth included in the study will be permanent upper or lower molars with MIH in children aged 7 to 9 years. Two properly calibrated examiners will select the participants, and the diagnosis of MIH lesions will be based on the criteria of the European Association of Paediatric Dentistry (EAPD). The inclusion criteria will be: one permanent molar without MIH; at least two permanent molars with mild MIH lesions (demarcated opacities without structural loss), with or without sensitivity, of a cream-white or yellowish color, and 2 mm in diameter; and without visible bacterial biofilm. The selected teeth from each participant will be divided into 3 groups: Control Group (molars without hypomineralization); CPP-ACPF Group (hypomineralized molars treated with CPP-ACPF); and NaOCl/CPP-ACPF Group (hypomineralized molars deproteinized with 5.25% NaOCl, with application time based on laboratory study findings, and treated with CPP-ACPF). The randomization of treatments for hypomineralized teeth will be performed at the time of treatment. The following data collection tools will be used: a questionnaire to collect demographic and socioeconomic information, as well as information on etiological factors for MIH; clinical examination to assess the following aspects of the lesions: location (occlusal or middle third), lesion area (in mm²), color (cream-white or yellowish), visual appearance (shiny or opaque), sensitivity, and lightness of the lesion color (L). The tooth's L will be measured three times to obtain the average of the values. The data will be analyzed descriptively and inferentially. Clinical analyses will include intragroup comparisons (between follow-up times) and intergroup comparisons (between group outcomes), at a 5% significance level.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control Group (molars without hypomineralization) | No intervention | –Health molars without hypomineralization |
| CPP-ACPF in hypomineralized molars | Experimental | Drug: CPP-ACPFHypomineralized molars treated with CPP-ACPF, without prior deproteinization. (Treatment will be administered once a week for 4 consecutive weeks). |
| Sodium hypochlorite 5.25%/CPP-ACPF Group | Experimental | Drug: Sodium hypochlorite 5.25%, Drug: CPP-ACPFHypomineralized molars treated with CPP-ACPF, with preliminary deproteinization (Treatment will be administered once a week for 4 consecutive weeks) |
Who may qualify
- Ages
- 7 to 9 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Children with at least one permanent molar without MIH.
- At least two permanent molars with mild MIH lesions (demarcated opacities without structural loss)
- Lesions may be with or without sensitivity
- Lesions cream-white or yellowish in color
- Lesions ≥ 2 mm in diameter
Key exclusion criteria (5 listed)
- Visible bacterial biofilm
- Enamel malformations associated with syndromes
- Amelogenesis imperfecta
- Fluorosis
- Allergy 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 |
|---|---|---|
| Sodium hypochlorite 5.25%Also: NaOCLSodium hypochlorite is a proteolytic substance that interferes with the cellular metabolism of proteins. | Drug | Sodium hypochlorite 5.25%/CPP-ACPF Group |
| CPP-ACPFAlso: Amorphous calcium fluoride casein phosphate phosphopeptideCasein is a milk-derived protein that, during enzymatic digestion in the mouth, is converted into a casein phosphopeptide (CPP) molecule. CPP is capable of stabilizing calcium, phosphate, and fluoride ions on the tooth surface, keeping them in an amorphous form. Thus, CPP-ACPF functions as a reservoir of calcium phosphate. | Drug | CPP-ACPF in hypomineralized molars, Sodium hypochlorite 5.25%/CPP-ACPF Group |
Primary outcome
Mineralization of MIH lesions
Time frame: 1 month
The measurements will be taken using a spectrophotometer (Vita Easyshade) to assess tooth brightness before and after treatment
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 8 Jul 2026.
- Background: PubMed 28872993Sonmez H, Saat S. A Clinical Evaluation of Deproteinization and Different Cavity Designs on Resin Restoration Performance in MIH-Affected Molars: Two-Year Results. J Clin Pediatr Dent. 2017;41(5):336-342. doi: 10.17796/1053-4628-41.5.336.
- Background: PubMed 20651090Mangum JE, Crombie FA, Kilpatrick N, Manton DJ, Hubbard MJ. Surface integrity governs the proteome of hypomineralized enamel. J Dent Res. 2010 Oct;89(10):1160-5. doi: 10.1177/0022034510375824. Epub 2010 Jul 22.
- Background: PubMed 15560832Mahoney E, Ismail FS, Kilpatrick N, Swain M. Mechanical properties across hypomineralized/hypoplastic enamel of first permanent molar teeth. Eur J Oral Sci. 2004 Dec;112(6):497-502. doi: 10.1111/j.1600-0722.2004.00162.x.
- Background: PubMed 22251382Gandhi S, Crawford P, Shellis P. The use of a 'bleach-etch-seal' deproteinization technique on MIH affected enamel. Int J Paediatr Dent. 2012 Nov;22(6):427-34. doi: 10.1111/j.1365-263X.2011.01212.x. Epub 2012 Jan 18.
- 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 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 28843745Elhennawy K, Manton DJ, Crombie F, Zaslansky P, Radlanski RJ, Jost-Brinkmann PG, Schwendicke F. Structural, mechanical and chemical evaluation of molar-incisor hypomineralization-affected enamel: A systematic review. Arch Oral Biol. 2017 Nov;83:272-281. doi: 10.1016/j.archoralbio.2017.08.008. Epub 2017 Aug 19.
- Background: PubMed 23363890Crombie FA, Cochrane NJ, Manton DJ, Palamara JE, Reynolds EC. Mineralisation of developmentally hypomineralised human enamel in vitro. Caries Res. 2013;47(3):259-63. doi: 10.1159/000346134. Epub 2013 Jan 29.
- 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 38744567Amend S, Stork S, Lucker S, Seipp A, Gartner U, Frankenberger R, Kramer N. Influence of different pre-treatments on the resin infiltration depth into enamel of teeth affected by molar-incisor hypomineralization (MIH). Dent Mater. 2024 Jul;40(7):1015-1024. doi: 10.1016/j.dental.2024.05.010. Epub 2024 May 13.
- 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 34821978Olgen 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.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sodium hypochlorite 5.25% and CPP-ACPF in people with Molar Incisor Hypomineralization, run by Universidade Ceuma 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 6 inclusion and 5 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 8 Jul 2026. 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?
Contact Meire C. Ferreira, PhD (+5598988955888, meirecofe@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mineralization of MIH lesions (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 NCT07653373, which also lists 13 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 8 Jul 2026.