- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04119180
Sedation Versus Protective Stabilization for Pediatric Dental Treatment
November 27, 2023 updated by: Luciane Ribeiro de Rezende Sucasas da Costa, Universidade Federal de Goias
Sedation Versus Protective Stabilization for Dental Treatment of Children With Caries and Negative Behavior at the Dentist: a Non-randomized Clinical 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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
152
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Luciane RS Costa, PhD
- Phone Number: +556232096325
- Email: lsucasas@ufg.br
Study Contact Backup
- Name: Paulo SS Costa, PhD
- Phone Number: +556232096151
- Email: paulosucasas@ufg.br
Study Locations
-
-
Goias
-
Goiania, Goias, Brazil, 74605220
- Recruiting
- Dental School - UFG
-
Contact:
- Luciane R Costa, DDS, MS, PhD
- Phone Number: 55 62 32096325
- Email: lsucasas@ufg.br
-
Sub-Investigator:
- Paulo SS Costa, MD, MS, PhD
-
Principal Investigator:
- Luciane RS Costa, PhD
-
-
SP
-
São Paulo, SP, Brazil, 05508-000
- Not yet recruiting
- Dental School - FOUSP
-
Contact:
- Daniela P Raggio, PhD
- Phone Number: +55 (11) 30917812
- Email: danielar@usp.br
-
Principal Investigator:
- Daniela P Raggio, PhD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 year to 7 years (Child)
Accepts Healthy Volunteers
Yes
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Sedation
The child receives sedatives approved for use in an outpatient setting, directed by a doctor, to accomplish the dental treatment.
|
Ketamine injectable solution in a concentration of 50.0 mg/mL via oral route; dose of 4.0 mg/kg maximum 100.0 mg
Other Names:
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;
Other Names:
|
Other: 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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Child behavior during the dental treatment
Time Frame: Participants will be followed for the duration of the dental session, an expected average of 40 minutes
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progression of child behavior throughout the follow-up
Time Frame: Baseline (dental examination) plus follow-up sessions at 4, 8, and 12 months post-treatment
|
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
|
Baseline (dental examination) plus follow-up sessions at 4, 8, and 12 months post-treatment
|
Progression of child dental anxiety throughout the follow-up
Time Frame: Baseline (dental examination) plus follow-up sessions at 4, 8, and 12 months post-treatment
|
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).
|
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
Time Frame: Baseline (dental examination) plus follow-up sessions at 4, 8, and 12 months post-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).
|
Baseline (dental examination) plus follow-up sessions at 4, 8, and 12 months post-treatment
|
Parental satisfaction with the intervention
Time Frame: At the end of each session from dental examination through the end of the dental treatment, an average of 2 months
|
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
|
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
Time Frame: At the end of each session from dental examination through the end of the dental treatment, an average of 2 months
|
A 10-centimeter Visual Analogue Scale (VAS) is used by the accompanying adult to measure her/his perceived stress (anxiety) with the child's dental session.
The VAS anchors are "relaxed" (left) and "too nervous" (right).
At the end of the session, raters mark a point on the 10 cm line to correspond to their level of stress (anxiety); 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 stress
|
At the end of each session from dental examination through the end of the dental treatment, an average of 2 months
|
Dentist's satisfaction with the intervention
Time Frame: At the end of each session from dental examination through the end of the dental treatment, an average of 2 months
|
A 10-centimeter Visual Analogue Scale (VAS) is used by the dentist in charge 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
|
At the end of each session from dental examination through the end of the dental treatment, an average of 2 months
|
Dentist's stress (anxiety) with the intervention
Time Frame: At the end of each session from dental examination through the end of the dental treatment, an average of 2 months
|
A 10-centimeter Visual Analogue Scale (VAS) is used by the dentist in charge to measure her/his perceived stress (anxiety) with the child's dental session.
The VAS anchors are "relaxed" (left) and "too nervous" (right).
At the end of the session, raters mark a point on the 10 cm line to correspond to their level of stress (anxiety); 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 stress
|
At the end of each session from dental examination through the end of the dental treatment, an average of 2 months
|
Child pain reported by the parent
Time Frame: At the end of each session from dental examination through the end of the dental treatment, an average of 2 months
|
A 10-centimeter Visual Analogue Scale (VAS) is used by the accompanying child to measure her/his perceived pain in the child undergoing dental treatment.
The VAS anchors are "no pain" (left) and "too much pain" (right).
At the end of the session, raters mark a point on the 10 cm line to correspond to the perceived level of child's pain; 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 child's pain according to the parent
|
At the end of each session from dental examination through the end of the dental treatment, an average of 2 months
|
Child pain reported by the dentist
Time Frame: At the end of each session from dental examination through the end of the dental treatment, an average of 2 months
|
A 10-centimeter Visual Analogue Scale (VAS) is used by the dentist in charge to measure her/his perceived pain in the child undergoing dental treatment.
The VAS anchors are "no pain" (left) and "too much pain" (right).
At the end of the session, raters mark a point on the 10 cm line to correspond to the perceived level of child's pain; 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 child's pain according to the dentist
|
At the end of each session from dental examination through the end of the dental treatment, an average of 2 months
|
Child pain/distress during the dental restoration session
Time Frame: Duration of the dental session, an expected average of 40 minutes
|
FLACC Pain Assessment Tool (Faces, Legs, Activity, Cry and Consolability) scored by trained and calibrated observers after watching the videos of the dental treatment.
The FLACC is a measurement used to assess pain for children between the ages of 2 months and 7 years.
The scale is scored in a range of 0-10 with 0 representing no pain and 10, too much pain.
The scale has five criteria, which are each assigned a score of 0, 1 or 2: face, legs, activity, cry and consolability (Merkel et al., 1997).
|
Duration of the dental session, an expected average of 40 minutes
|
Adverse events during the dental procedure
Time Frame: 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
|
Occurrence of adverse events assessed by the Tracking and Reporting Outcomes of Procedural Sedation (TROOPS) (Roback et al. 2018) in the Moderate Sedation Group, or occurrence of bruises or inconsolability in the protective stabilization group
|
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
|
Number of teeth restored
Time Frame: End of each session of dental treatment, an average of 2 months
|
Restored teeth count at the end of each session
|
End of each session of dental treatment, an average of 2 months
|
Longevity of composite resin and glass ionomer cement restorations
Time Frame: 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)
|
Trained and calibrated observers will follow the criteria for assessing occlusal (Frencken and Holmgren 2001) or occlusal-proximal (Roeleveld et al. 2006) restorations to categorize each restoration as successful or failed
|
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)
|
Children's stress according to salivary cortisol
Time Frame: Change from baseline in the salivary cortisol at an expected average of 40 minutes
|
Occurrence of stress during dental procedure, assessed by salivary cortisol in children; the ELISA test will determine changes in cortisol level during dental treatment
|
Change from baseline in the salivary cortisol at an expected average of 40 minutes
|
Cost analysis
Time Frame: An expected average of 15 months
|
Cost-efficacy of different sedation protocols according to the methodology of health technologies assessment; the cost of each intervention will be compared
|
An expected average of 15 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Luciane RS Costa, PhD, Universidade Federal de Goias
- Study Director: Daniela P Raggio, PhD, University of Sao Paulo
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 30, 2020
Primary Completion (Estimated)
February 28, 2024
Study Completion (Estimated)
February 28, 2024
Study Registration Dates
First Submitted
October 1, 2019
First Submitted That Met QC Criteria
October 4, 2019
First Posted (Actual)
October 8, 2019
Study Record Updates
Last Update Posted (Actual)
November 29, 2023
Last Update Submitted That Met QC Criteria
November 27, 2023
Last Verified
November 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Stomatognathic Diseases
- Tooth Demineralization
- Tooth Diseases
- Dental Caries
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anesthetics, Dissociative
- Anesthetics, Intravenous
- Anesthetics, General
- Anesthetics
- Excitatory Amino Acid Antagonists
- Excitatory Amino Acid Agents
- Tranquilizing Agents
- Psychotropic Drugs
- Hypnotics and Sedatives
- Adjuvants, Anesthesia
- Anti-Anxiety Agents
- GABA Modulators
- GABA Agents
- Ketamine
- Midazolam
Other Study ID Numbers
- PI03925-2019
- 424339/2018-8 (Other Grant/Funding Number: CNPq)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
All IPD that underlie results in a publication
IPD Sharing Time Frame
2023 to 2024
IPD Sharing Access Criteria
According to the digital platform rules.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- ICF
Study Data/Documents
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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