Sedation Versus Protective Stabilization for Pediatric Dental Treatment

NCT04119180 | Recruiting Phase 4

• 2 other identifiers: PI03925-2019424339/2018-8
• Study Type: interventional
• Target: 152
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Child Behavior; Dental Caries in Children

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Child behavior during the dental treatment

  Children's behavior assessed by OSUBRS (Ohio State University Behavioral Rating Scale) in digital videos recorded during the administration. Scores: 1 - quiet, 2 - cry with movement, 3 - movement without cry; 4 - struggling. The higher the percentage of time of care in which the child behaves quietly, the better their behavior. Measurements for each group will be synthesized as mean (or median) and standard deviation (or interquartile range).

  Participants will be followed for the duration of the dental session, an expected average of 40 minutes

Secondary Outcomes (15)

• Progression of child behavior throughout the follow-up

  Baseline (dental examination) plus follow-up sessions at 4, 8, and 12 months post-treatment

• Progression of child dental anxiety throughout the follow-up

  Baseline (dental examination) plus follow-up sessions at 4, 8, and 12 months post-treatment

• Impact on oral health-related quality of life and changes after treatment

  Baseline (dental examination) plus follow-up sessions at 4, 8, and 12 months post-treatment

• Parental satisfaction with the intervention

  At the end of each session from dental examination through the end of the dental treatment, an average of 2 months

• Parental stress (anxiety) with the intervention

  At the end of each session from dental examination through the end of the dental treatment, an average of 2 months

Study Arms (2)

Sedation

EXPERIMENTAL

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

Drug: Ketamine 50 MG/ML; Drug: Midazolam Hcl 2Mg/Ml Syrup

Control

OTHER

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.

Procedure: Protective stabilization

Interventions

Ketamine 50 MG/ML 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

Also known as: Ketamin S, Cristalia, São Paulo, Brazil

Sedation

Midazolam Hcl 2Mg/Ml Syrup 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;

Also known as: Dormire oral solution, Cristalia, Sao Paulo, Brazil

Sedation

Protective stabilization 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.

Control

Eligibility Criteria

• Age: 1 Year - 7 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidade Federal de Goias: lead
• University of Sao Paulo: collaborator
• King's College London: collaborator

Study Sites (2)

Dental School - UFG

Goiânia, Goiás, 74605220, Brazil

ACTIVE NOT RECRUITING

Dental School - FOUSP

São Paulo, São Paulo, 05508-000, Brazil

RECRUITING

Related Publications (1)

• 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.

  PMID: 33980232 DERIVED

MeSH Terms

Conditions

Child Behavior; Dental Caries

Interventions

Ketamine; Midazolam

Condition Hierarchy (Ancestors)

Behavior; Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Luciane RS Costa, PhD

  Universidade Federal de Goias

  PRINCIPAL INVESTIGATOR

• Daniela P Raggio, PhD

  University of Sao Paulo

  STUDY DIRECTOR

• Patricia C Faria, PhD

  Universidade Federal de Goias

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Patricia C Faria, PhD

CONTACT

6232096325; patriciacorreafaria@ufg.br

Luciane R Costa, PhD

CONTACT

+556232096325; lsucasas@ufg.br

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 1, 2019
• First Posted: October 8, 2019
• Study Start: January 30, 2020
• Primary Completion: February 28, 2025
• Study Completion: February 28, 2026
• Last Updated: December 10, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: 2023 to 2024
• Access Criteria: According to the digital platform rules.

Locations

BR (2)