Sedation Versus Protective Stabilization for Pediatric Dental Treatment
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age1-7
SponsorUniversidade Federal de Goias
About this trial
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
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Ketamine 50 MG/ML
DrugKetamine 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
DrugMidazolam 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;
Protective stabilization
Procedure/SurgeryThe 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.
Treatment groups
152 Participants
are divided into 2 treatment groupsGroup A: SedationExperimental treatment 2 interventions
Group B: ControlOther 1 intervention
Trial outcomes
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).
Time frame
Participants will be followed for the duration of the dental session, an expected average of 40 minutesSecondary outcomes
1
Progression of child behavior throughout the follow-up
A 10-centimeter Visual Analogue Scale (VAS) is used by one of the trained/calibrated dentists to measure the child behavior during the dental session (Hosey and Blinkhorn, 2005). The VAS anchors are "negative behavior" (left) and "positive behavior" (right). At the end of the session, raters mark a point on the 10 cm line to correspond to the perceived level of behavior; this is then measured using a ruler to give a score to the nearest millimeter which can vary from 0 to 100). The higher the VAS score, the better the child's behavior assessed by the dentist
Time frame
Baseline (dental examination) plus follow-up sessions at 4, 8, and 12 months post-treatment2
Progression of child dental anxiety throughout the follow-up
Facial Image Scale (Buchanan and Niven, 2002), a row of five faces ranging from "very happy" to "very sad," and numbered from 1 (very happy, most positive response) to 5 (very sad, the most negative).
Time frame
Baseline (dental examination) plus follow-up sessions at 4, 8, and 12 months post-treatment3
Impact on oral health-related quality of life and changes after treatment
The B-ECOHIS is a measure of oral health-related quality of life (OHRQoL) validated in Brazil by Scarpelli et al. (2008) to assess the impact of oral health problems and related treatment on the quality of life of children aged zero to five years and their families. "The ECOHIS consists of 13 questions divided into two main parts: child impact section (part one) and family impact section (part two). The child impact section comprises of four subscales: child symptom, child function, child psychology and child self-image/social interaction. The family impact section contains two subscales: parental distress and family function. The questionnaire is scored using a simple five-point Likert scale with responses ranging from "never" to "very often" (equivalent to a score of 0 and 4, respectively). A total score ranging from zero to 52 is calculated as a simple sum of the responses with higher scores denoting a greater oral health impact and/or poorer OHRQoL." (Martins-Junior et a. 2012).
Time frame
Baseline (dental examination) plus follow-up sessions at 4, 8, and 12 months post-treatment4
Parental satisfaction with the intervention
A 10-centimeter Visual Analogue Scale (VAS) is used by the accompanying adult to measure her/his satisfaction with the child's dental session. The VAS anchors are "no satisfaction" (left) and "extreme satisfaction" (right). At the end of the session, raters mark a point on the 10 cm line to correspond to their level of satisfaction; this is then measured using a ruler to give a score to the nearest millimeter, which can vary from 0 to 100. The higher the VAS score, the greater the respondent satisfaction
Time frame
At the end of each session from dental examination through the end of the dental treatment, an average of 2 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Universidade Federal de Goias
Lead sponsor
University of Sao Paulo
Collaborator
King's College London
Collaborator
Source ClinicalTrials.gov