An investigator-blinded, 24-month, parallel-group, non-inferiority study to compare aesthetic restorations in primary anterior teeth in a paediatric dental clinic: study protocol for a randomised controlled trial
Introduction Children who suffer from severe caries in childhood may have negative impacts on the growth, development, nutritional problems and quality-of-life problems related to the oral health of the child and their family. There are no studies that have compared rehabilitative techniques of prim...
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BMJ Publishing Group
2025-02-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/15/2/e086200.full |
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| author | Ana Paula Taboada Sobral Elaine Marcilio Santos Marcela Leticia Leal Gonçalves Lara Jansiski Motta Anna Carolina Ratto Tempestini Horliana Sandra Kalil Bussadori Elza Padilha Ferri Juliana Maria Altavista Sagretti Gallo Thais Gimenez José Carlos Pettorossi Imparato |
| author_facet | Ana Paula Taboada Sobral Elaine Marcilio Santos Marcela Leticia Leal Gonçalves Lara Jansiski Motta Anna Carolina Ratto Tempestini Horliana Sandra Kalil Bussadori Elza Padilha Ferri Juliana Maria Altavista Sagretti Gallo Thais Gimenez José Carlos Pettorossi Imparato |
| author_sort | Ana Paula Taboada Sobral |
| collection | DOAJ |
| description | Introduction Children who suffer from severe caries in childhood may have negative impacts on the growth, development, nutritional problems and quality-of-life problems related to the oral health of the child and their family. There are no studies that have compared rehabilitative techniques of primary anterior teeth regarding patient-centred outcomes and even longevity of the restoration. Thus, this project aims to evaluate the effectiveness of restorative treatment of anterior primary teeth with monochromatic composite resin in single insertion through polyvinyl crowns, after selective removal of carious tissue compared with the effectiveness of conventional restoration.Methods and analysis This study proposes to conduct a randomised clinical trial, composed of a sample of 194 deciduous central and lateral incisors with active cavitated lesions, simplified International Caries Detection and Assessment System (ICDAS) C+ score (active and extensive stage caries: ICDAS 5 and 6), with involvement of more than two surfaces. This sample will be divided into two experimental groups, both with selective removal of carious tissue: a group in which conventional restoration will be performed using opaque resins, and another group with monochrome resin with chameleon effect and polyvinyl crowns. The explanatory variables—gender, age, toothbrushing, use of fluoridated toothpaste and dental floss, and socioeconomic status—will be collected through a questionnaire with open questions. The progression of caries lesions after 24 months of follow-up will be considered as the primary outcome. Secondary outcomes will include tooth survival, longevity of restoration, quality of life, perception and satisfaction of the participants’ parents/guardians.Ethics and dissemination This protocol has been approved by the Human Research Ethics Committee of Universidade Metropolitana de Santos (protocol number: 6.019.297. Approved 24 April 2023). Results will be submitted to international peer-reviewed journals and presented at international conferences.Trial registration number NCT05875064. |
| format | Article |
| id | doaj-art-28b2f566e0d64ba5999166f7cfb083f9 |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2025-02-01 |
| publisher | BMJ Publishing Group |
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| series | BMJ Open |
| spelling | doaj-art-28b2f566e0d64ba5999166f7cfb083f92025-02-07T06:50:20ZengBMJ Publishing GroupBMJ Open2044-60552025-02-0115210.1136/bmjopen-2024-086200An investigator-blinded, 24-month, parallel-group, non-inferiority study to compare aesthetic restorations in primary anterior teeth in a paediatric dental clinic: study protocol for a randomised controlled trialAna Paula Taboada Sobral0Elaine Marcilio Santos1Marcela Leticia Leal Gonçalves2Lara Jansiski Motta3Anna Carolina Ratto Tempestini Horliana4Sandra Kalil Bussadori5Elza Padilha Ferri6Juliana Maria Altavista Sagretti Gallo7Thais Gimenez8José Carlos Pettorossi Imparato92 Postgraduation Program in Health and Environment, Universidade Metropolitana de Santos, Santos, Brazil2 Postgraduation Program in Health and Environment, Universidade Metropolitana de Santos, Santos, Brazil2 Postgraduation Program in Health and Environment, Universidade Metropolitana de Santos, Santos, Brazil5 Postgraduate program in Biophotonics Applied to Health Sciences, Universidade Nove de Julho - Campus Vergueiro, Sao Paulo, SP, Brazil5 Postgraduate program in Biophotonics Applied to Health Sciences, Universidade Nove de Julho - Campus Vergueiro, Sao Paulo, SP, Brazil3 School of Dentistry, Universidade Metropolitana de Santos, Santos, Brazil3 School of Dentistry, Universidade Metropolitana de Santos, Santos, Brazil4 Postgraduation Program in Veterinary Medicine in the Coastal Environment, Universidade Metropolitana de Santos, Santos, Brazil1 School of Dentistry, Universidade de São Paulo, São Paulo, Brazil1 School of Dentistry, Universidade de São Paulo, São Paulo, BrazilIntroduction Children who suffer from severe caries in childhood may have negative impacts on the growth, development, nutritional problems and quality-of-life problems related to the oral health of the child and their family. There are no studies that have compared rehabilitative techniques of primary anterior teeth regarding patient-centred outcomes and even longevity of the restoration. Thus, this project aims to evaluate the effectiveness of restorative treatment of anterior primary teeth with monochromatic composite resin in single insertion through polyvinyl crowns, after selective removal of carious tissue compared with the effectiveness of conventional restoration.Methods and analysis This study proposes to conduct a randomised clinical trial, composed of a sample of 194 deciduous central and lateral incisors with active cavitated lesions, simplified International Caries Detection and Assessment System (ICDAS) C+ score (active and extensive stage caries: ICDAS 5 and 6), with involvement of more than two surfaces. This sample will be divided into two experimental groups, both with selective removal of carious tissue: a group in which conventional restoration will be performed using opaque resins, and another group with monochrome resin with chameleon effect and polyvinyl crowns. The explanatory variables—gender, age, toothbrushing, use of fluoridated toothpaste and dental floss, and socioeconomic status—will be collected through a questionnaire with open questions. The progression of caries lesions after 24 months of follow-up will be considered as the primary outcome. Secondary outcomes will include tooth survival, longevity of restoration, quality of life, perception and satisfaction of the participants’ parents/guardians.Ethics and dissemination This protocol has been approved by the Human Research Ethics Committee of Universidade Metropolitana de Santos (protocol number: 6.019.297. Approved 24 April 2023). Results will be submitted to international peer-reviewed journals and presented at international conferences.Trial registration number NCT05875064.https://bmjopen.bmj.com/content/15/2/e086200.full |
| spellingShingle | Ana Paula Taboada Sobral Elaine Marcilio Santos Marcela Leticia Leal Gonçalves Lara Jansiski Motta Anna Carolina Ratto Tempestini Horliana Sandra Kalil Bussadori Elza Padilha Ferri Juliana Maria Altavista Sagretti Gallo Thais Gimenez José Carlos Pettorossi Imparato An investigator-blinded, 24-month, parallel-group, non-inferiority study to compare aesthetic restorations in primary anterior teeth in a paediatric dental clinic: study protocol for a randomised controlled trial BMJ Open |
| title | An investigator-blinded, 24-month, parallel-group, non-inferiority study to compare aesthetic restorations in primary anterior teeth in a paediatric dental clinic: study protocol for a randomised controlled trial |
| title_full | An investigator-blinded, 24-month, parallel-group, non-inferiority study to compare aesthetic restorations in primary anterior teeth in a paediatric dental clinic: study protocol for a randomised controlled trial |
| title_fullStr | An investigator-blinded, 24-month, parallel-group, non-inferiority study to compare aesthetic restorations in primary anterior teeth in a paediatric dental clinic: study protocol for a randomised controlled trial |
| title_full_unstemmed | An investigator-blinded, 24-month, parallel-group, non-inferiority study to compare aesthetic restorations in primary anterior teeth in a paediatric dental clinic: study protocol for a randomised controlled trial |
| title_short | An investigator-blinded, 24-month, parallel-group, non-inferiority study to compare aesthetic restorations in primary anterior teeth in a paediatric dental clinic: study protocol for a randomised controlled trial |
| title_sort | investigator blinded 24 month parallel group non inferiority study to compare aesthetic restorations in primary anterior teeth in a paediatric dental clinic study protocol for a randomised controlled trial |
| url | https://bmjopen.bmj.com/content/15/2/e086200.full |
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