Effect of Enamel Cleaning on a Remineralizing Paste for Hypomineralizated Lesions (ECLIPSE)

June 11, 2026 updated by: Meire Coelho Ferreira, Universidade Ceuma

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. 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 amorphous calcium fluoride casein phosphate phosphopeptide (CPP-ACPF) dental mousse on deproteinized hypomineralized enamel.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Molar-incisor hypomineralization (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 casein phosphopeptide-amorphous calcium phosphate fluoride (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 HMI; 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 Type

Interventional

Enrollment (Estimated)

54

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Brazil
    • Maranhão
      • São Luís, Maranhão, Brazil, 65075-120
        • Universidade Ceuma

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Children must have at least one permanent molar without MIH, at least two permanent molars with mild MIH lesions (demarcated opacities without structural loss), with or without sensitivity, that are cream-white or yellowish in color and at least 2 mm in diameter. The teeth with lesions may or may not be on the same dental arch.

Exclusion Criteria:

  • Children with visible bacterial biofilm, enamel malformations associated with syndromes, amelogenesis imperfecta, or fluorosis, and children who are allergic to milk proteins (casein) will not be eligible to participate in the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control Group (molars without hypomineralization)
Health molars without hypomineralization
Experimental: CPP-ACPF in hypomineralized molars
Hypomineralized molars treated with CPP-ACPF, without prior deproteinization. (Treatment will be administered once a week for 4 consecutive weeks).
Drug: CPP-ACPF
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.
Other Names:
  • Amorphous calcium fluoride casein phosphate phosphopeptide
Experimental: Sodium hypochlorite 5.25%/CPP-ACPF Group
Hypomineralized molars treated with CPP-ACPF, with preliminary deproteinization (Treatment will be administered once a week for 4 consecutive weeks)
Drug: CPP-ACPF
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.
Other Names:
  • Amorphous calcium fluoride casein phosphate phosphopeptide
Drug: Sodium hypochlorite 5.25%
Sodium hypochlorite is a proteolytic substance that interferes with the cellular metabolism of proteins.
Other Names:
  • NaOCL

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidade Ceuma

Collaborators

Fundação de Amparo à Pesquisa e Desenvolvimento Científico do Maranhão

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 1, 2026

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

April 1, 2028

Study Registration Dates

First Submitted

June 11, 2026

First Submitted That Met QC Criteria

June 11, 2026

First Posted (Actual)

June 17, 2026

Study Record Updates

Last Update Posted (Actual)

June 17, 2026

Last Update Submitted That Met QC Criteria

June 11, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UnCeuma

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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