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Sedation Versus Protective Stabilization for Pediatric Dental Treatment

NCT ID: NCT04119180

Last Updated: 2024-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

152 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-30

Study Completion Date

2026-02-28

Brief Summary

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There is a lack of evidence on the effectiveness of moderate sedation in pediatric dentistry, compared to protective stabilization, which remains routinely used in the Brazilian context despite moral questions. The objective of this prospective nonrandomized clinical trial is to evaluate the effectiveness of the use of moderate sedation, compared to the protective stabilization, in the dental care of children with fear / anxiety and / or dental behavior problem, and associated factors. The study will be carried out in outpatient clinics of the Dental Schools of the Federal University of Goiás (UFG) and University of São Paulo (USP), with the support of professors from King's College London through the partnership CEDACORE - Children Experiencing Dental Anxiety: Collaboration on Research and Education. Participants will be 152 children under 7 years of age with dental caries, who need specialized dental treatment due to a history of non-cooperation with dental care. The interventions to be compared are moderate sedation with oral administration of ketamine and midazolam (UFG) and protective stabilization (USP). The primary endpoint 'behavior / anxiety of the child during treatment will be assessed using the Ohio State University Behavioral Rating Scale. The secondary outcomes are: dental behavioral and anxiety evolution of the child, child' pain during procedure, impact on the quality of life related to oral health, parents and dentists' satisfaction and stress, adverse events for sedated participants, longevity of composite and glass ionomer cement restorations, chronotype and physiological stress of these children. A cost-efficacy analysis will be produced at the end of the study from the perspective of the Sistema Único de Saúde. Additionally, at the end of 36 months, the investigators expect to contribute to the identification of psychosocial aspects related to dental behavior problems in children in early childhood. It is important to highlight the perspective of technological innovation, with the creation of a digital platform that will allow the registration of data related to the dental care of children worldwide and favor analyzes in the methodology of data science.

Detailed Description

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Conditions

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Child Behavior Dental Caries in Children

Keywords

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Dental Anxiety Dental Caries Conscious Sedation Physical Restraint Cost-Efficacy Analysis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Sedation

The child receives sedatives approved for use in an outpatient setting, directed by a doctor, to accomplish the dental treatment.

Group Type EXPERIMENTAL

Ketamine 50 MG/ML

Intervention Type DRUG

Ketamine injectable solution in a concentration of 50.0 mg/mL via oral route; dose of 4.0 mg/kg maximum 100.0 mg

Midazolam Hcl 2Mg/Ml Syrup

Intervention Type DRUG

Midazolam oral solution in a concentration of 2.0 mg/mL via oral route; dose of 0.5 mg/kg, maximum 5.0 mg when associated with ketamine;

Control

The child does not receive sedatives. As s/he exhibits negative behavior for the dental procedure, s/he will be restrained by a family member and dental team.

Group Type OTHER

Protective stabilization

Intervention Type PROCEDURE

The legal guardian or accompanying person appointed by the legal guardian should sit in the dental chair with the child and contain leg and arm movements. A dental assistant keeps the child's head contained during care.

Interventions

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Ketamine 50 MG/ML

Ketamine injectable solution in a concentration of 50.0 mg/mL via oral route; dose of 4.0 mg/kg maximum 100.0 mg

Intervention Type DRUG

Midazolam Hcl 2Mg/Ml Syrup

Midazolam oral solution in a concentration of 2.0 mg/mL via oral route; dose of 0.5 mg/kg, maximum 5.0 mg when associated with ketamine;

Intervention Type DRUG

Protective stabilization

The legal guardian or accompanying person appointed by the legal guardian should sit in the dental chair with the child and contain leg and arm movements. A dental assistant keeps the child's head contained during care.

Intervention Type PROCEDURE

Other Intervention Names

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Ketamin S, Cristalia, São Paulo, Brazil Dormire oral solution, Cristalia, Sao Paulo, Brazil

Eligibility Criteria

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Inclusion Criteria

* Children presenting cavities that need dental restoration
* ASA I (healthy) or II (mild and controlled systemic disease - persistent asthma, for example) children (ASA, 2015)
* Medical history without neurological or cognitive impairment
* Children who do not use medicines that may impair cognitive functions
* Children at low risk for airway obstruction (Mallampati less than 2 and / or tonsil hypertrophy occupying less than 50% of the oropharynx) (Mallampati et al., 1985)

Exclusion Criteria

* Children with positive or definitely positive behavior (Frankl et al. 1962) in the dental examination session
* Non-attendance at the first intervention appointment after three scheduling attempts
* Chronic use of systemic corticosteroids
Minimum Eligible Age

1 Year

Maximum Eligible Age

7 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Sao Paulo

OTHER

Sponsor Role collaborator

King's College London

OTHER

Sponsor Role collaborator

Universidade Federal de Goias

OTHER

Sponsor Role lead

Responsible Party

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Luciane Ribeiro de Rezende Sucasas da Costa

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Luciane RS Costa, PhD

Role: PRINCIPAL_INVESTIGATOR

Universidade Federal de Goias

Daniela P Raggio, PhD

Role: STUDY_DIRECTOR

University of Sao Paulo

Patricia C Faria, PhD

Role: PRINCIPAL_INVESTIGATOR

Universidade Federal de Goias

Locations

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Dental School - UFG

Goiânia, Goiás, Brazil

Site Status ACTIVE_NOT_RECRUITING

Dental School - FOUSP

São Paulo, São Paulo, Brazil

Site Status RECRUITING

Countries

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Brazil

Central Contacts

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Patricia C Faria, PhD

Role: CONTACT

Phone: 6232096325

Email: [email protected]

Luciane R Costa, PhD

Role: CONTACT

Phone: +556232096325

Email: [email protected]

Facility Contacts

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Daniela P Raggio, PhD

Role: primary

References

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da Silva GS, Anabuki AA, Viana KA, Correa-Faria P, Moterane MM, Tedesco TK, Costa PS, Hosey MT, Raggio DP, Costa LR; 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 May 12;21(1):256. doi: 10.1186/s12903-021-01594-0.

Reference Type DERIVED
PMID: 33980232 (View on PubMed)

Study Documents

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Document Type: Study Protocol

View Document

Other Identifiers

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424339/2018-8

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

PI03925-2019

Identifier Type: -

Identifier Source: org_study_id