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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

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Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
54

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

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Study Contact

Study Contact

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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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universidade Ceuma

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Fundação de Amparo à Pesquisa e Desenvolvimento Científico do Maranhão

Publications and helpful links

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General Publications

Study record dates

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Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 11, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 11, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 17, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 17, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 11, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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