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Sedation versus protective stabilization for dental treatment of children with caries and challenging behavior at the dentist (CHOOSE): a study protocol for a non-randomized clinical trial

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Sedation versus protective stabilization for dental treatment of children with caries and challenging behavior at the dentist (CHOOSE) : a study protocol for a non-randomized clinical trial. / CEDACORE Collaborative Group.

In: BMC Oral Health, Vol. 21, No. 1, 256, 12.2021.

Research output: Contribution to journalArticlepeer-review

Harvard

CEDACORE Collaborative Group 2021, 'Sedation versus protective stabilization for dental treatment of children with caries and challenging behavior at the dentist (CHOOSE): a study protocol for a non-randomized clinical trial', BMC Oral Health, vol. 21, no. 1, 256. https://doi.org/10.1186/s12903-021-01594-0

APA

CEDACORE Collaborative Group (2021). Sedation versus protective stabilization for dental treatment of children with caries and challenging behavior at the dentist (CHOOSE): a study protocol for a non-randomized clinical trial. BMC Oral Health, 21(1), [256]. https://doi.org/10.1186/s12903-021-01594-0

Vancouver

CEDACORE Collaborative Group. Sedation versus protective stabilization for dental treatment of children with caries and challenging behavior at the dentist (CHOOSE): a study protocol for a non-randomized clinical trial. BMC Oral Health. 2021 Dec;21(1). 256. https://doi.org/10.1186/s12903-021-01594-0

Author

CEDACORE Collaborative Group. / Sedation versus protective stabilization for dental treatment of children with caries and challenging behavior at the dentist (CHOOSE) : a study protocol for a non-randomized clinical trial. In: BMC Oral Health. 2021 ; Vol. 21, No. 1.

Bibtex Download

@article{86199fb65f774ee4a83d1b9ada3688f1,
title = "Sedation versus protective stabilization for dental treatment of children with caries and challenging behavior at the dentist (CHOOSE): a study protocol for a non-randomized clinical trial",
abstract = "Background: There is a lack of evidence on the effectiveness of moderate sedation in pediatric dentistry, compared to protective stabilization, which remains routinely used in Brazil despite moral questions. This prospective non-randomized clinical trial's objective is to evaluate the effectiveness of moderate sedation, compared to the protective stabilization, in the dental care of children with dental behavior management problems. Methods: Participants will be 152 children under seven years of age with early childhood caries (ECC) who need specialized dental treatment due to a history of challenging behavior during dental care. The interventions to be compared are moderate sedation with oral administration of ketamine and midazolam and protective stabilization. The primary endpoint will be the child's behavior during treatment assessed using the Ohio State University Behavioral Rating Scale (OSUBRS). The secondary outcomes are (A) child's – behavior according to the visual analogue scale, anxiety, pain, and physiological stress; (B) parent's – satisfaction and anxiety; (C) family and child – impact on oral health-related quality of life (OHRQoL); (D) dentist's – satisfaction and stress; (E) procedure – adverse events of the intervention and dental treatment longevity. A cost-effectiveness analysis will be performed from the perspective of the Brazilian Unified Health System (SUS). Discussion: Considering the primary outcome, this study hypothesis is that sedated children have better behavior during dental treatment than children whose behavior was managed by protective stabilization without sedation. Additionally, at the end of 12 months, we expect to identify participants' reported outcomes and objective measures related to dental behavior in early childhood. Trial registration Clinicaltrials.gov registration NCT04119180 on October 8th, 2019. https://clinicaltrials.gov/ct2/show/NCT04119180",
keywords = "Child behavior, Conscious sedation, Cost-effectiveness analysis, Dental anxiety, Dental care for children, Dental caries, Physical restraint",
author = "{CEDACORE Collaborative Group} and {da Silva}, {Gabriela Seabra} and Anabuki, {Anna Alice} and Viana, {Karolline Alves} and Patricia Corr{\^e}a-Faria and Moterane, {M{\^o}nica Maia} and Tedesco, {Tamara Kerber} and Costa, {Paulo Sucasas} and Hosey, {Marie Therese} and Raggio, {Daniela Pr{\'o}cida} and Costa, {Luciane Rezende}",
note = "Funding Information: The authors would like to thank the Conselho Nacional de Desenvolvimento Cient{\'i}fico e Tecnol{\'o}gico — CNPq—Chamada Universal (Grant # 424339/2018-8) for funding this trial and also for providing research scholarships to DPR and LRC, and postgraduate scholarships to AAA and MMM. CNPq does not play a role in the study's design and collection, data analysis and interpretation, and manuscript writing. Publisher Copyright: {\textcopyright} 2021, The Author(s). Copyright: Copyright 2021 Elsevier B.V., All rights reserved.",
year = "2021",
month = dec,
doi = "10.1186/s12903-021-01594-0",
language = "English",
volume = "21",
journal = "BMC Oral Health ",
issn = "1472-6831",
publisher = "BioMed Central",
number = "1",

}

RIS (suitable for import to EndNote) Download

TY - JOUR

T1 - Sedation versus protective stabilization for dental treatment of children with caries and challenging behavior at the dentist (CHOOSE)

T2 - a study protocol for a non-randomized clinical trial

AU - CEDACORE Collaborative Group

AU - da Silva, Gabriela Seabra

AU - Anabuki, Anna Alice

AU - Viana, Karolline Alves

AU - Corrêa-Faria, Patricia

AU - Moterane, Mônica Maia

AU - Tedesco, Tamara Kerber

AU - Costa, Paulo Sucasas

AU - Hosey, Marie Therese

AU - Raggio, Daniela Prócida

AU - Costa, Luciane Rezende

N1 - Funding Information: The authors would like to thank the Conselho Nacional de Desenvolvimento Científico e Tecnológico — CNPq—Chamada Universal (Grant # 424339/2018-8) for funding this trial and also for providing research scholarships to DPR and LRC, and postgraduate scholarships to AAA and MMM. CNPq does not play a role in the study's design and collection, data analysis and interpretation, and manuscript writing. Publisher Copyright: © 2021, The Author(s). Copyright: Copyright 2021 Elsevier B.V., All rights reserved.

PY - 2021/12

Y1 - 2021/12

N2 - Background: There is a lack of evidence on the effectiveness of moderate sedation in pediatric dentistry, compared to protective stabilization, which remains routinely used in Brazil despite moral questions. This prospective non-randomized clinical trial's objective is to evaluate the effectiveness of moderate sedation, compared to the protective stabilization, in the dental care of children with dental behavior management problems. Methods: Participants will be 152 children under seven years of age with early childhood caries (ECC) who need specialized dental treatment due to a history of challenging behavior during dental care. The interventions to be compared are moderate sedation with oral administration of ketamine and midazolam and protective stabilization. The primary endpoint will be the child's behavior during treatment assessed using the Ohio State University Behavioral Rating Scale (OSUBRS). The secondary outcomes are (A) child's – behavior according to the visual analogue scale, anxiety, pain, and physiological stress; (B) parent's – satisfaction and anxiety; (C) family and child – impact on oral health-related quality of life (OHRQoL); (D) dentist's – satisfaction and stress; (E) procedure – adverse events of the intervention and dental treatment longevity. A cost-effectiveness analysis will be performed from the perspective of the Brazilian Unified Health System (SUS). Discussion: Considering the primary outcome, this study hypothesis is that sedated children have better behavior during dental treatment than children whose behavior was managed by protective stabilization without sedation. Additionally, at the end of 12 months, we expect to identify participants' reported outcomes and objective measures related to dental behavior in early childhood. Trial registration Clinicaltrials.gov registration NCT04119180 on October 8th, 2019. https://clinicaltrials.gov/ct2/show/NCT04119180

AB - Background: There is a lack of evidence on the effectiveness of moderate sedation in pediatric dentistry, compared to protective stabilization, which remains routinely used in Brazil despite moral questions. This prospective non-randomized clinical trial's objective is to evaluate the effectiveness of moderate sedation, compared to the protective stabilization, in the dental care of children with dental behavior management problems. Methods: Participants will be 152 children under seven years of age with early childhood caries (ECC) who need specialized dental treatment due to a history of challenging behavior during dental care. The interventions to be compared are moderate sedation with oral administration of ketamine and midazolam and protective stabilization. The primary endpoint will be the child's behavior during treatment assessed using the Ohio State University Behavioral Rating Scale (OSUBRS). The secondary outcomes are (A) child's – behavior according to the visual analogue scale, anxiety, pain, and physiological stress; (B) parent's – satisfaction and anxiety; (C) family and child – impact on oral health-related quality of life (OHRQoL); (D) dentist's – satisfaction and stress; (E) procedure – adverse events of the intervention and dental treatment longevity. A cost-effectiveness analysis will be performed from the perspective of the Brazilian Unified Health System (SUS). Discussion: Considering the primary outcome, this study hypothesis is that sedated children have better behavior during dental treatment than children whose behavior was managed by protective stabilization without sedation. Additionally, at the end of 12 months, we expect to identify participants' reported outcomes and objective measures related to dental behavior in early childhood. Trial registration Clinicaltrials.gov registration NCT04119180 on October 8th, 2019. https://clinicaltrials.gov/ct2/show/NCT04119180

KW - Child behavior

KW - Conscious sedation

KW - Cost-effectiveness analysis

KW - Dental anxiety

KW - Dental care for children

KW - Dental caries

KW - Physical restraint

UR - http://www.scopus.com/inward/record.url?scp=85105837214&partnerID=8YFLogxK

U2 - 10.1186/s12903-021-01594-0

DO - 10.1186/s12903-021-01594-0

M3 - Article

C2 - 33980232

AN - SCOPUS:85105837214

VL - 21

JO - BMC Oral Health

JF - BMC Oral Health

SN - 1472-6831

IS - 1

M1 - 256

ER -

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