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

NCT06330272 | Active Not Recruiting DMC

• 1 other identifier: UCeuma
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

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.

Conditions

Molar Incisor Hypomineralization

Keywords

molar hypomineralization; tooth mousse plus; tooth remineralization; data accuracy

Outcome Measures

Primary Outcomes (1)

• To measure the accuracy of a spectrophotometer (VITA Easyshade V) in determining the mineralization of IMH lesions by a CPP-ACPF dental mousse

  The spectrophotometry analysis was determined by the Kappa statistic (95% confidence interval) (primary outcome of the study).

  1 month

Study Arms (1)

CPP-ACPF treatment

EXPERIMENTAL

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.

Procedure: Application of dental mousse based on CPP-ACPF

Interventions

Application of dental mousse based on CPP-ACPF 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.

CPP-ACPF treatment

Eligibility Criteria

• Age: 7 Years - 9 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Meire Coelho Ferreira: lead
• Fundação de Amparo à Pesquisa e Desenvolvimento Científico do Maranhão: collaborator

Study Sites (1)

Josue Montello, Universidade Ceuma

São Luís, Maranhão, 65075-120, Brazil

Location

Related Publications (20)

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

  PMID: 20403298 BACKGROUND

• 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.

  PMID: 37400849 BACKGROUND

• 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.

  PMID: 27098755 BACKGROUND

• 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.

  PMID: 19893971 BACKGROUND

• 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.

  PMID: 33524270 BACKGROUND

• 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.

  PMID: 21149856 BACKGROUND

• 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.

  PMID: 36551842 BACKGROUND

• 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.

  PMID: 20738434 BACKGROUND

• 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

  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.

  PMID: 20392131 BACKGROUND

• 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.

  PMID: 25998233 BACKGROUND

• 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.

  PMID: 34164793 BACKGROUND

• 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.

  PMID: 20403299 BACKGROUND

• 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.

  PMID: 34057698 BACKGROUND

• 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.

  PMID: 34821978 BACKGROUND

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

  PMID: 18254423 BACKGROUND

• 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.

  PMID: 35830636 BACKGROUND

• 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.

  PMID: 19253064 BACKGROUND

• 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.

  PMID: 11641576 BACKGROUND

• 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.

  PMID: 28288296 BACKGROUND

MeSH Terms

Conditions

Molar Hypomineralization

Condition Hierarchy (Ancestors)

Dental Enamel Hypomineralization; Developmental Defects of Enamel; Tooth Abnormalities; Stomatognathic System Abnormalities; Stomatognathic Diseases; Tooth Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Meire C. Ferreira, PhD

  Uniceuma

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: MIH lesions will receive prophylaxis with pumice stone before application of CPP-ACPF-based dental foam (Tooth Mousse PlusTM, GC Corporation, Tokyo, Japan). 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 cream will remain on the surface for 1 minute. The application will be carried out once a week, for four consecutive weeks.

Study Record Dates

• First Submitted: March 19, 2024
• First Posted: March 26, 2024
• Study Start: May 15, 2025
• Primary Completion: December 15, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 21, 2025

Record last verified: 2025-05

Locations

BR (1)