Child BehaviorPhase 4NCT04119180
Sedation Versus Protective Stabilization for Pediatric Dental Treatment
A Phase 4 study testing Ketamine 50 MG/ML, Midazolam Hcl 2Mg/Ml Syrup and Protective stabilization in people with Child Behavior and Dental Caries in Children, run by Universidade Federal de Goias at 2 sites in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year to 7 yearsHealthy volunteers can take part
- Conditions the study is for
- Child Behavior, Dental Caries in Children
- What is being tested?
- Ketamine 50 MG/ML, Midazolam Hcl 2Mg/Ml Syrup and Protective stabilization
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 152 participants
- Where
- 2 sitesBrazil
- Study dates
- 30 Jan 2020to 28 Feb 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 7 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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)
Who cannot join
- 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 locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil2 sites, 1 recruiting
- Active, not recruiting
Dental School - UFG
Goiânia, Goiás, 74605220
- Recruiting
Dental School - FOUSP
São Paulo, São Paulo, 05508-000
Daniela P Raggio, PhD, +55 (11) 30917812, danielar@usp.br
Daniela P Raggio, PhD
About this study
Official title: 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.
- Conditions
- Child Behavior, Dental Caries in Children
- Being tested
- Ketamine 50 MG/ML, Midazolam Hcl 2Mg/Ml Syrup, Protective stabilization
- Keywords
- Dental Anxiety, Dental Caries, Conscious Sedation, Physical Restraint, Cost-Efficacy Analysis
- Medical subject headings
- Child Behavior, Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketamine 50 MG/MLDrug
Also called Ketamin S, Cristalia, São Paulo, Brazil
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 SyrupDrug
Also called Dormire oral solution, Cristalia, Sao Paulo, Brazil
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;
Protective stabilizationProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Sedation | Experimental | The child receives sedatives approved for use in an outpatient setting, directed by a doctor, to accomplish the dental treatment. Receives: 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. Receives: Procedure: Protective stabilization |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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
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
Measured: Baseline (dental examination) plus follow-up sessions at 4, 8, and 12 months post-treatment
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).
Measured: 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
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).
Measured: Baseline (dental examination) plus follow-up sessions at 4, 8, and 12 months post-treatment
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
Measured: 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
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
Measured: 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
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
Measured: 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
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
Measured: 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
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
Measured: 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
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
Measured: 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
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).
Measured: Duration of the dental session, an expected average of 40 minutes
Adverse events during the dental procedure
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
Measured: 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
Restored teeth count at the end of each session
Measured: End of each session of dental treatment, an average of 2 months
Longevity of composite resin and glass ionomer cement restorations
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
Measured: 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
Occurrence of stress during dental procedure, assessed by salivary cortisol in children; the ELISA test will determine changes in cortisol level during dental treatment
Measured: Change from baseline in the salivary cortisol at an expected average of 40 minutes
Cost analysis
Cost-efficacy of different sedation protocols according to the methodology of health technologies assessment; the cost of each intervention will be compared
Measured: An expected average of 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2019
- Study start30 Jan 2020
- Primary completion28 Feb 2025 (estimated)
- Study completion28 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Child BehaviorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 152 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade Federal de Goias
- Sponsor type
- University, hospital or other
- Collaborators
- University of Sao Paulo, King's College London
- Responsible party
- Principal investigator, Luciane Ribeiro de Rezende Sucasas da Costa, Universidade Federal de Goias
- Investigators
- Luciane RS Costa, PhD, Principal investigator, Universidade Federal de GoiasDaniela P Raggio, PhD, Study director, University of Sao PauloPatricia C Faria, PhD, Principal investigator, Universidade Federal de Goias
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04119180
- Sponsor's protocol ID
- PI03925-2019
- Other IDs
- 424339/2018-8
- Status last verified
- Dec 2024
- First submitted
- 1 Oct 2019
- Last updated
- 10 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD that underlie results in a publication
Publications
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.
PubMed 33980232
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sedation Versus Protective Stabilization for Dental Treatment of Children With Caries and Negative Behavior at the Dentist: a Non-randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04119180
- Acronym / sponsor ID
- PI03925-2019
- Conditions
- Child Behavior, Dental Caries in Children
- Keywords
- Dental Anxiety, Dental Caries, Conscious Sedation, Physical Restraint, Cost-Efficacy Analysis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 152 participants (estimated)
- Lead sponsor
- Universidade Federal de GoiasUniversity, hospital or other
- Collaborators
- University of Sao Paulo, King's College London
- Study start
- 30 Jan 2020 (actual)
- Primary completion
- 28 Feb 2025 (estimated)
- Study completion
- 28 Feb 2026 (estimated)
- First posted
- 8 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sedation | Experimental | Drug: Ketamine 50 MG/ML, Drug: Midazolam Hcl 2Mg/Ml SyrupThe child receives sedatives approved for use in an outpatient setting, directed by a doctor, to accomplish the dental treatment. |
| Control | Other | Procedure: Protective stabilizationThe 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. |
Who may qualify
- Ages
- 1 year to 7 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ketamine 50 MG/MLAlso: Ketamin S, Cristalia, São Paulo, BrazilKetamine injectable solution in a concentration of 50.0 mg/mL via oral route; dose of 4.0 mg/kg maximum 100.0 mg | Drug | Sedation |
| Midazolam Hcl 2Mg/Ml SyrupAlso: Dormire oral solution, Cristalia, Sao Paulo, BrazilMidazolam 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; | Drug | Sedation |
| Protective stabilizationThe 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. | Procedure or surgery | Control |
Primary outcome
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).
15 secondary outcomes
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
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
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
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
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
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
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
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
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
Child pain/distress during the dental restoration session
Time frame: 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
Number of teeth restored
Time frame: 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)
Children's stress according to salivary cortisol
Time frame: Change from baseline in the salivary cortisol at an expected average of 40 minutes
Cost analysis
Time frame: An expected average of 15 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2024.
- Derived from this study: PubMed 33980232da 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.
- Individual participant dataSharing planned: Yes. All IPD that underlie results in a publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Luciane RS Costa, PhD principal investigator
Universidade Federal de Goias
Daniela P Raggio, PhD study director
University of Sao Paulo
Patricia C Faria, PhD principal investigator
Universidade Federal de Goias
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ketamine 50 MG/ML, Midazolam Hcl 2Mg/Ml Syrup and Protective stabilization in people with Child Behavior and Dental Caries in Children, run by Universidade Federal de Goias at 2 sites in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Patricia C Faria, PhD (6232096325, patriciacorreafaria@ufg.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04119180, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2024.