Evaluation of antimicrobial photodynamic therapy and minimal intervention associated with deproteinisation in permanent teeth with molar incisor hypomineralisation: study protocol for a clinical, controlled, blinded trial

Introduction Molar incisor hypomineralisation (MIH) is a qualitative defect of enamel development that occurs in the mineralisation phase. MIH affects one or more permanent molars and, occasionally, permanent incisors. The aim of the proposed study is to evaluate the clinical effect of antimicrobial...

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Main Authors: Ana Paula Taboada Sobral, Marcela Leticia Leal Gonçalves, Lara Jansiski Motta, Anna Carolina Ratto Tempestini Horliana, Kristianne Porta Santos Fernandes, Sandra Kalil Bussadori, Raquel Agnelli Mesquita Ferrari, Amanda Rafaelly Honório Mandetta, Carolina Carvalho Bortoletto, Renato Araujo Prates, Alessandro Melo Deana, Rita de Cássia Loiola Cordeiro, Lourdes Aparecida Martins dos Santos Pinto
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Language:English
Published: BMJ Publishing Group 2023-12-01
Series:BMJ Open
Online Access:https://bmjopen.bmj.com/content/13/12/e076226.full
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author Ana Paula Taboada Sobral
Marcela Leticia Leal Gonçalves
Lara Jansiski Motta
Anna Carolina Ratto Tempestini Horliana
Kristianne Porta Santos Fernandes
Sandra Kalil Bussadori
Raquel Agnelli Mesquita Ferrari
Amanda Rafaelly Honório Mandetta
Carolina Carvalho Bortoletto
Renato Araujo Prates
Alessandro Melo Deana
Rita de Cássia Loiola Cordeiro
Lourdes Aparecida Martins dos Santos Pinto
author_facet Ana Paula Taboada Sobral
Marcela Leticia Leal Gonçalves
Lara Jansiski Motta
Anna Carolina Ratto Tempestini Horliana
Kristianne Porta Santos Fernandes
Sandra Kalil Bussadori
Raquel Agnelli Mesquita Ferrari
Amanda Rafaelly Honório Mandetta
Carolina Carvalho Bortoletto
Renato Araujo Prates
Alessandro Melo Deana
Rita de Cássia Loiola Cordeiro
Lourdes Aparecida Martins dos Santos Pinto
author_sort Ana Paula Taboada Sobral
collection DOAJ
description Introduction Molar incisor hypomineralisation (MIH) is a qualitative defect of enamel development that occurs in the mineralisation phase. MIH affects one or more permanent molars and, occasionally, permanent incisors. The aim of the proposed study is to evaluate the clinical effect of antimicrobial photodynamic therapy (aPDT) on permanent teeth with MIH through decontamination and sensitivity control.Methods and analysis Patients from 8 to 12 years of age with permanent molars will be randomly allocated to three groups. Group 1: selective chemical–mechanical removal of carious dentinal tissue around the walls of the cavity with Papacárie Duo and a curette followed by the application of aPDT and deproteinisation with Papacárie Duo; group 2: selective removal of carious dentinal tissue around the walls of the cavity with a curette, followed by the application of aPDT and deproteinisation with a 5% sodium hypochlorite solution; group 3: selective removal of carious dentinal tissue using a curette. The selected teeth must have a carious lesion in the dentin and posteruptive enamel breakdown on one or more surfaces with an indication for clinical restorative treatment. The teeth will subsequently be restored using a mixed technique with resin-modified glass ionomer cement and bulk-fill composite resin. The data will be submitted to descriptive statistical analysis. Associations with age and sex will be tested using either the χ2 test or Fisher’s exact test. Pearson’s correlation coefficients will be calculated to determine the strength of correlations between variables. Comparisons of the microbiological results (colony-forming units) will be performed using analysis of variance and the Kruskal-Wallis test. Kaplan-Meier survival analysis will be performed to assess the performance of the restorations.Ethics and dissemination This protocol has been approved by the Human Research Ethics Committee of Nove de Julho University (certificate number: 61027522.0.0000.5511/approval date: 23 August 2022). The findings will be published in a peer-reviewed journal.Trial registration number NCT05443035.
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spelling doaj-art-9979a23f9a5440c49ced6ca0914ca4bf2025-08-20T02:11:12ZengBMJ Publishing GroupBMJ Open2044-60552023-12-01131210.1136/bmjopen-2023-076226Evaluation of antimicrobial photodynamic therapy and minimal intervention associated with deproteinisation in permanent teeth with molar incisor hypomineralisation: study protocol for a clinical, controlled, blinded trialAna Paula Taboada Sobral0Marcela Leticia Leal Gonçalves1Lara Jansiski Motta2Anna Carolina Ratto Tempestini Horliana3Kristianne Porta Santos Fernandes4Sandra Kalil Bussadori5Raquel Agnelli Mesquita Ferrari6Amanda Rafaelly Honório Mandetta7Carolina Carvalho Bortoletto8Renato Araujo Prates9Alessandro Melo Deana10Rita de Cássia Loiola Cordeiro11Lourdes Aparecida Martins dos Santos Pinto123 School of Dentistry, Universidade Metropolitana de Santos, Santos, Brazil2 Postgraduation Program in Health and Environment, Universidade Metropolitana de Santos, Santos, Brazil6 Nove de Julho University, São Paulo, Brazil5 Postgraduate program in Biophotonics Applied to Health Sciences, Universidade Nove de Julho - Campus Vergueiro, Sao Paulo, SP, BrazilPostgraduate Program in Biophotonics Applied to Health Sciences, Universidade Nove de Julho, Campus Vergueiro, São Paulo, SP, BrazilSchool of Dentistry, Universidade Metropolitana de Santos, Santos, SP, BrazilPostgraduate Program in Biophotonics Applied to Health Sciences, Universidade Nove de Julho, Campus Vergueiro, São Paulo, SP, Brazil4 Postgraduate Program in Biophotonics Applied to Health Sciences, Universidade Nove de Julho, São Paulo, São Paulo, BrazilSchool of Dentistry, Universidade Nove de Julho, São Paulo, SP, BrazilPostgraduate Program in Biophotonics Applied to Health Sciences, Universidade Nove de Julho, Campus Vergueiro, São Paulo, SP, BrazilPostgraduate Program in Biophotonics Applied to Health Sciences, Universidade Nove de Julho, Campus Vergueiro, São Paulo, SP, BrazilResearch of Department of Pediatric Dentistry, Universidade Estadual Paulista Júlio de Mesquita Filho, Campus de Araraquara, Araraquara, SP, BrazilResearch of Department of Pediatric Dentistry, Universidade Estadual Paulista Júlio de Mesquita Filho, Campus de Araraquara, Araraquara, SP, BrazilIntroduction Molar incisor hypomineralisation (MIH) is a qualitative defect of enamel development that occurs in the mineralisation phase. MIH affects one or more permanent molars and, occasionally, permanent incisors. The aim of the proposed study is to evaluate the clinical effect of antimicrobial photodynamic therapy (aPDT) on permanent teeth with MIH through decontamination and sensitivity control.Methods and analysis Patients from 8 to 12 years of age with permanent molars will be randomly allocated to three groups. Group 1: selective chemical–mechanical removal of carious dentinal tissue around the walls of the cavity with Papacárie Duo and a curette followed by the application of aPDT and deproteinisation with Papacárie Duo; group 2: selective removal of carious dentinal tissue around the walls of the cavity with a curette, followed by the application of aPDT and deproteinisation with a 5% sodium hypochlorite solution; group 3: selective removal of carious dentinal tissue using a curette. The selected teeth must have a carious lesion in the dentin and posteruptive enamel breakdown on one or more surfaces with an indication for clinical restorative treatment. The teeth will subsequently be restored using a mixed technique with resin-modified glass ionomer cement and bulk-fill composite resin. The data will be submitted to descriptive statistical analysis. Associations with age and sex will be tested using either the χ2 test or Fisher’s exact test. Pearson’s correlation coefficients will be calculated to determine the strength of correlations between variables. Comparisons of the microbiological results (colony-forming units) will be performed using analysis of variance and the Kruskal-Wallis test. Kaplan-Meier survival analysis will be performed to assess the performance of the restorations.Ethics and dissemination This protocol has been approved by the Human Research Ethics Committee of Nove de Julho University (certificate number: 61027522.0.0000.5511/approval date: 23 August 2022). The findings will be published in a peer-reviewed journal.Trial registration number NCT05443035.https://bmjopen.bmj.com/content/13/12/e076226.full
spellingShingle Ana Paula Taboada Sobral
Marcela Leticia Leal Gonçalves
Lara Jansiski Motta
Anna Carolina Ratto Tempestini Horliana
Kristianne Porta Santos Fernandes
Sandra Kalil Bussadori
Raquel Agnelli Mesquita Ferrari
Amanda Rafaelly Honório Mandetta
Carolina Carvalho Bortoletto
Renato Araujo Prates
Alessandro Melo Deana
Rita de Cássia Loiola Cordeiro
Lourdes Aparecida Martins dos Santos Pinto
Evaluation of antimicrobial photodynamic therapy and minimal intervention associated with deproteinisation in permanent teeth with molar incisor hypomineralisation: study protocol for a clinical, controlled, blinded trial
BMJ Open
title Evaluation of antimicrobial photodynamic therapy and minimal intervention associated with deproteinisation in permanent teeth with molar incisor hypomineralisation: study protocol for a clinical, controlled, blinded trial
title_full Evaluation of antimicrobial photodynamic therapy and minimal intervention associated with deproteinisation in permanent teeth with molar incisor hypomineralisation: study protocol for a clinical, controlled, blinded trial
title_fullStr Evaluation of antimicrobial photodynamic therapy and minimal intervention associated with deproteinisation in permanent teeth with molar incisor hypomineralisation: study protocol for a clinical, controlled, blinded trial
title_full_unstemmed Evaluation of antimicrobial photodynamic therapy and minimal intervention associated with deproteinisation in permanent teeth with molar incisor hypomineralisation: study protocol for a clinical, controlled, blinded trial
title_short Evaluation of antimicrobial photodynamic therapy and minimal intervention associated with deproteinisation in permanent teeth with molar incisor hypomineralisation: study protocol for a clinical, controlled, blinded trial
title_sort evaluation of antimicrobial photodynamic therapy and minimal intervention associated with deproteinisation in permanent teeth with molar incisor hypomineralisation study protocol for a clinical controlled blinded trial
url https://bmjopen.bmj.com/content/13/12/e076226.full
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