An interventional study of Sodium hypochlorite 5.25% and CPP-ACPF in Molar Incisor Hypomineralization, sponsored by Universidade Ceuma. Not yet recruiting at 1 site in Brazil. Open to participants aged 7 Years to 9 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-08.
Sponsored by Universidade Ceuma · Not applicable, Interventional, and Treatment
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.
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.
121 studies on the registry are indexed under Molar Hypomineralization; 41 are open to participants now.
This study's planned enrollment of 54 is close to the median of 52 across 94 interventional studies indexed under Molar Hypomineralization.
Browse Molar Hypomineralization studies →Universidade Ceuma is the lead sponsor of 4 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
Health molars without hypomineralization
Hypomineralized molars treated with CPP-ACPF, without prior deproteinization. (Treatment will be administered once a week for 4 consecutive weeks).
Drug: CPP-ACPF
Hypomineralized molars treated with CPP-ACPF, with preliminary deproteinization (Treatment will be administered once a week for 4 consecutive weeks)
Drug: Sodium hypochlorite 5.25% · Drug: CPP-ACPF
Sodium hypochlorite is a proteolytic substance that interferes with the cellular metabolism of proteins.
Also known as: NaOCL
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.
Also known as: Amorphous calcium fluoride casein phosphate phosphopeptide
Mineralization of MIH lesions
The measurements will be taken using a spectrophotometer (Vita Easyshade) to assess tooth brightness before and after treatment
Time frame: 1 month
Plan to share: No
This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Universidade Ceuma