Clinical trial NCT04119180: Sedation Versus Protective Stabilization for Pediatric Dental Treatment
Official title: Sedation Versus Protective Stabilization for Dental Treatment of Children With Caries and Negative Behavior at the Dentist: a Non-randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Child Behavior
Dental Caries in Children
Keywords: Dental Anxiety
Dental Caries
Conscious Sedation
Physical Restraint
Cost-Efficacy Analysis
Lead sponsor: Universidade Federal de Goias
Sponsor class: OTHER
Collaborators: name: University of Sao Paulo
name: King's College London
First posted: 2019-10-08
Enrollment: 152
Sex: ALL
Minimum age (years): 1
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Child behavior during the dental treatment
timeFrame: Participants will be followed for the duration of the dental session, an expected average of 40 minutes
Secondary outcomes:
measure: Progression of child behavior throughout the follow-up
timeFrame: Baseline (dental examination) plus follow-up sessions at 4, 8, and 12 months post-treatment
measure: Progression of child dental anxiety throughout the follow-up
timeFrame: Baseline (dental examination) plus follow-up sessions at 4, 8, and 12 months post-treatment
measure: Impact on oral health-related quality of life and changes after treatment
timeFrame: Baseline (dental examination) plus follow-up sessions at 4, 8, and 12 months post-treatment
measure: Parental satisfaction with the intervention
timeFrame: At the end of each session from dental examination through the end of the dental treatment, an average of 2 months
measure: Parental stress (anxiety) with the intervention
timeFrame: At the end of each session from dental examination through the end of the dental treatment, an average of 2 months
measure: Dentist's satisfaction with the intervention
timeFrame: At the end of each session from dental examination through the end of the dental treatment, an average of 2 months
measure: Dentist's stress (anxiety) with the intervention
timeFrame: At the end of each session from dental examination through the end of the dental treatment, an average of 2 months
measure: Child pain reported by the parent
timeFrame: At the end of each session from dental examination through the end of the dental treatment, an average of 2 months
measure: Child pain reported by the dentist
timeFrame: At the end of each session from dental examination through the end of the dental treatment, an average of 2 months
measure: Child pain/distress during the dental restoration session
timeFrame: Duration of the dental session, an expected average of 40 minutes
measure: Adverse events during the dental procedure
timeFrame: Participants will be followed for the duration of the dental session, an expected average of 40 minutes. Sedated patients will also be followed in the recovery room, an expected average of 60 minutes
measure: Number of teeth restored
timeFrame: End of each session of dental treatment, an average of 2 months
measure: Longevity of composite resin and glass ionomer cement restorations
timeFrame: At a time point of 5 minutes (average) after the end of the dental procedure, and in the follow-up sessions (4, 8 and 12 months)
measure: Children's stress according to salivary cortisol
timeFrame: Change from baseline in the salivary cortisol at an expected average of 40 minutes
measure: Cost analysis
timeFrame: An expected average of 15 months
Other outcomes:
Locations:
city: Goiania
country: Brazil
facility: Dental School - UFG
state: Goias
city: São Paulo
country: Brazil
facility: Dental School - FOUSP
state: SP
Study officials:
affiliation: Universidade Federal de Goias
name: Luciane RS Costa, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Sao Paulo
name: Daniela P Raggio, PhD
role: STUDY_DIRECTOR
affiliation: Universidade Federal de Goias
name: Patricia C Faria, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.