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

NCT ID: NCT06330272

Last Updated: 2025-05-21

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 98 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-15
• Study Completion Date: 2026-12-31

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).

Conditions

Molar Incisor Hypomineralization

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CPP-ACPF treatment

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.

Group Type: EXPERIMENTAL

Application of dental mousse based on CPP-ACPF

Intervention Type: PROCEDURE

Treatment will begin with pumice prophylaxis of incisors with IMH lesions. After this step, the teeth will be dried before applying dental foam based on CPP-ACPF (Tooth Mousse PlusTM, GC Corporation, Tokyo, Japan).

The application of Tooth Mousse PlusTM to the MIH lesion will be carried out under relative isolation and with the aid of a microbrush. The cream will remain on the surface for 1 minute, which will be timed. The application will be carried out once a week, for four consecutive weeks.

Interventions

Application of dental mousse based on CPP-ACPF

Treatment will begin with pumice prophylaxis of incisors with IMH lesions. After this step, the teeth will be dried before applying dental foam based on CPP-ACPF (Tooth Mousse PlusTM, GC Corporation, Tokyo, Japan).

The application of Tooth Mousse PlusTM to the MIH lesion will be carried out under relative isolation and with the aid of a microbrush. The cream will remain on the surface for 1 minute, which will be timed. The application will be carried out once a week, for four consecutive weeks.

Intervention Type: PROCEDURE

Eligibility Criteria

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).

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 9 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Fundação de Amparo à Pesquisa e Desenvolvimento Científico do Maranhão

UNKNOWN

Sponsor Role: collaborator

Meire Coelho Ferreira

OTHER

Sponsor Role: lead

Responsible Party

Meire Coelho Ferreira

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Meire C. Ferreira, PhD

Role: STUDY_DIRECTOR

Uniceuma

Locations

Josue Montello, Universidade Ceuma

São Luís, Maranhão, Brazil

Countries

Brazil

References

Alaluusua S. Aetiology of Molar-Incisor Hypomineralisation: A systematic review. Eur Arch Paediatr Dent. 2010 Apr;11(2):53-8. doi: 10.1007/BF03262713.

Reference Type: BACKGROUND

PMID: 20403298 (View on PubMed)

Altan 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.

Reference Type: BACKGROUND

PMID: 37400849 (View on PubMed)

Americano 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.

Reference Type: BACKGROUND

PMID: 27098755 (View on PubMed)

Aranha AC, Pimenta LA, Marchi GM. Clinical evaluation of desensitizing treatments for cervical dentin hypersensitivity. Braz Oral Res. 2009 Jul-Sep;23(3):333-9. doi: 10.1590/s1806-83242009000300018.

Reference Type: BACKGROUND

PMID: 19893971 (View on PubMed)

Bandeira Lopes L, Machado V, Botelho J, Haubek D. Molar-incisor hypomineralization: an umbrella review. Acta Odontol Scand. 2021 Jul;79(5):359-369. doi: 10.1080/00016357.2020.1863461. Epub 2021 Feb 1.

Reference Type: BACKGROUND

PMID: 33524270 (View on PubMed)

Baroni C, Marchionni S. MIH supplementation strategies: prospective clinical and laboratory trial. J Dent Res. 2011 Mar;90(3):371-6. doi: 10.1177/0022034510388036. Epub 2010 Dec 13.

Reference Type: BACKGROUND

PMID: 21149856 (View on PubMed)

Cardoso-Martins I, Pessanha S, Coelho A, Arantes-Oliveira S, Marques PF. Evaluation of the Efficacy of CPP-ACP Remineralizing Mousse in Molar-Incisor Hypomineralized Teeth Using Polarized Raman and Scanning Electron Microscopy-An In Vitro Study. Biomedicines. 2022 Dec 1;10(12):3086. doi: 10.3390/biomedicines10123086.

Reference Type: BACKGROUND

PMID: 36551842 (View on PubMed)

da Costa-Silva CM, Jeremias F, de Souza JF, Cordeiro Rde C, Santos-Pinto L, Zuanon AC. Molar incisor hypomineralization: prevalence, severity and clinical consequences in Brazilian children. Int J Paediatr Dent. 2010 Nov;20(6):426-34. doi: 10.1111/j.1365-263X.2010.01097.x. Epub 2010 Aug 24.

Reference Type: BACKGROUND

PMID: 20738434 (View on PubMed)

Dias CSCF, Giotto LM, Oliveira Favretto C. O Uso De Vernizes Fluoretados Nos Tratamentos De Hipersensibilidade Dentinária: Uma Abordagem Atual. Rev Saúde Multidiscip. 2022;11(1):20-5

Reference Type: BACKGROUND

Fagrell 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.

Reference Type: BACKGROUND

PMID: 20392131 (View on PubMed)

Bullio 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.

Reference Type: BACKGROUND

PMID: 25998233 (View on PubMed)

Garot E, Rouas P, Somani C, Taylor GD, Wong F, Lygidakis NA. An update of the aetiological factors involved in molar incisor hypomineralisation (MIH): a systematic review and meta-analysis. Eur Arch Paediatr Dent. 2022 Feb;23(1):23-38. doi: 10.1007/s40368-021-00646-x. Epub 2021 Jun 24.

Reference Type: BACKGROUND

PMID: 34164793 (View on PubMed)

Jalevik B. Prevalence and Diagnosis of Molar-Incisor- Hypomineralisation (MIH): A systematic review. Eur Arch Paediatr Dent. 2010 Apr;11(2):59-64. doi: 10.1007/BF03262714.

Reference Type: BACKGROUND

PMID: 20403299 (View on PubMed)

Kumar 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.

Reference Type: BACKGROUND

PMID: 34057698 (View on PubMed)

Olgen 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.

Reference Type: BACKGROUND

PMID: 34821978 (View on PubMed)

Rodd HD, Boissonade FM, Day PF. Pulpal status of hypomineralized permanent molars. Pediatr Dent. 2007 Nov-Dec;29(6):514-20.

Reference Type: BACKGROUND

PMID: 18254423 (View on PubMed)

Sezer B, Kargul B. Effect of Remineralization Agents on Molar-Incisor Hypomineralization-Affected Incisors: A Randomized Controlled Clinical Trial. J Clin Pediatr Dent. 2022 May 1;46(3):192-198. doi: 10.17796/1053-4625-46.3.4.

Reference Type: BACKGROUND

PMID: 35830636 (View on PubMed)

Soviero V, Haubek D, Trindade C, Da Matta T, Poulsen S. Prevalence and distribution of demarcated opacities and their sequelae in permanent 1st molars and incisors in 7 to 13-year-old Brazilian children. Acta Odontol Scand. 2009;67(3):170-5. doi: 10.1080/00016350902758607.

Reference Type: BACKGROUND

PMID: 19253064 (View on PubMed)

Weerheijm KL, Jalevik B, Alaluusua S. Molar-incisor hypomineralisation. Caries Res. 2001 Sep-Oct;35(5):390-1. doi: 10.1159/000047479. No abstract available.

Reference Type: BACKGROUND

PMID: 11641576 (View on PubMed)

Zawaideh FI, Owais AI, Mushtaha S. Effect of CPP-ACP or a Potassium Nitrate Sodium Fluoride Dentifrice on Enamel Erosion Prevention. J Clin Pediatr Dent. 2017;41(2):135-140. doi: 10.17796/1053-4628-41.2.135.

Reference Type: BACKGROUND

PMID: 28288296 (View on PubMed)

Other Identifiers

UCeuma

Identifier Type: -

Identifier Source: org_study_id