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| Name | Class |
|---|---|
| Fundação de Amparo à Pesquisa e Desenvolvimento CientÃfico do Maranhão | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Group (molars without hypomineralization) | No Intervention | Health molars without hypomineralization | |
| CPP-ACPF in hypomineralized molars | Experimental | Hypomineralized molars treated with CPP-ACPF, without prior deproteinization. (Treatment will be administered once a week for 4 consecutive weeks). |
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| Sodium hypochlorite 5.25%/CPP-ACPF Group | Experimental | Hypomineralized molars treated with CPP-ACPF, with preliminary deproteinization (Treatment will be administered once a week for 4 consecutive weeks) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sodium hypochlorite 5.25% | Drug | Sodium hypochlorite is a proteolytic substance that interferes with the cellular metabolism of proteins. |
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| Measure | Description | Time Frame |
|---|---|---|
| Mineralization of MIH lesions | The measurements will be taken using a spectrophotometer (Vita Easyshade) to assess tooth brightness before and after treatment | 1 month |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Meire C. Ferreira, PhD | Contact | +5598988955888 | meirecofe@hotmail.com | |
| Nicole P. Veras, PhD | Contact | 05598983088600 | npaivaveras@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universidade Ceuma | São LuÃs | Maranhão | 65075-120 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28872993 | Background | Sonmez H, Saat S. A Clinical Evaluation of Deproteinization and Different Cavity Designs on Resin Restoration Performance in MIH-Affected Molars: Two-Year Results. J Clin Pediatr Dent. 2017;41(5):336-342. doi: 10.17796/1053-4628-41.5.336. | |
| 20651090 | Background | Mangum JE, Crombie FA, Kilpatrick N, Manton DJ, Hubbard MJ. Surface integrity governs the proteome of hypomineralized enamel. J Dent Res. 2010 Oct;89(10):1160-5. doi: 10.1177/0022034510375824. Epub 2010 Jul 22. |
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| ID | Term |
|---|---|
| D000094604 | Molar Hypomineralization |
| ID | Term |
|---|---|
| D000094603 | Dental Enamel Hypomineralization |
| D000094602 | Developmental Defects of Enamel |
| D014071 | Tooth Abnormalities |
| D018640 | Stomatognathic System Abnormalities |
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| CPP-ACPF | Drug | 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. |
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| 15560832 | Background | Mahoney E, Ismail FS, Kilpatrick N, Swain M. Mechanical properties across hypomineralized/hypoplastic enamel of first permanent molar teeth. Eur J Oral Sci. 2004 Dec;112(6):497-502. doi: 10.1111/j.1600-0722.2004.00162.x. |
| 22251382 | Background | Gandhi S, Crawford P, Shellis P. The use of a 'bleach-etch-seal' deproteinization technique on MIH affected enamel. Int J Paediatr Dent. 2012 Nov;22(6):427-34. doi: 10.1111/j.1365-263X.2011.01212.x. Epub 2012 Jan 18. |
| 25998233 | 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. |
| 20392131 | 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. |
| 28843745 | Background | Elhennawy K, Manton DJ, Crombie F, Zaslansky P, Radlanski RJ, Jost-Brinkmann PG, Schwendicke F. Structural, mechanical and chemical evaluation of molar-incisor hypomineralization-affected enamel: A systematic review. Arch Oral Biol. 2017 Nov;83:272-281. doi: 10.1016/j.archoralbio.2017.08.008. Epub 2017 Aug 19. |
| 23363890 | Background | Crombie FA, Cochrane NJ, Manton DJ, Palamara JE, Reynolds EC. Mineralisation of developmentally hypomineralised human enamel in vitro. Caries Res. 2013;47(3):259-63. doi: 10.1159/000346134. Epub 2013 Jan 29. |
| 27098755 | 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. |
| 38744567 | Background | Amend S, Stork S, Lucker S, Seipp A, Gartner U, Frankenberger R, Kramer N. Influence of different pre-treatments on the resin infiltration depth into enamel of teeth affected by molar-incisor hypomineralization (MIH). Dent Mater. 2024 Jul;40(7):1015-1024. doi: 10.1016/j.dental.2024.05.010. Epub 2024 May 13. |
| 37400849 | 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. |
| 34821978 | 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. |
| 34057698 | 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. |
| D009057 | Stomatognathic Diseases |
| D014076 | Tooth Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |