Accuracy of Spectrophotometry in Hypomineralized Lesions Treated With CPP-ACPF Dental Mousse: Clinical Study

Not Applicable

Active, not recruiting

• Conditions: Molar Incisor Hypomineralization
• Interventions: Procedure: Application of dental mousse based on CPP-ACPF

• Registration Number: NCT06330272
• Lead Sponsor: Meire Coelho Ferreira

Brief 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. 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 Timeline

• Study First Submitted: 2024-03-19
• Study First Submitted QC: 2024-03-19
• Study First Posted: 2024-03-26
• Status Verified: 2025-05
• Study Start: 2025-05-15
• Last Update Submitted: 2025-05-16
• Last Update Posted: 2025-05-21
• Primary Completion: 2025-12-15
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 98

Inclusion Criteria

• 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.

Exclusion Criteria

• Children with enamel malformation associated with syndromes, amelogenesis imperfecta, fluorosis and dental erosion;
• Children allergic to milk proteins (casein).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CPP-ACPF treatment	Application of dental mousse based on CPP-ACPF	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.

Primary Outcome Measures

Name	Time	Method
To measure the accuracy of a spectrophotometer (VITA Easyshade V) in determining the mineralization of IMH lesions by a CPP-ACPF dental mousse	1 month	The spectrophotometry analysis was determined by the Kappa statistic (95% confidence interval) (primary outcome of the study).

Trial Locations

Locations (1)

Josue Montello, Universidade Ceuma; 🇧🇷 São Luis, Maranhão, Brazil