Sedation Versus Protective Stabilization for Pediatric Dental Treatment

• ClinicalTrials.gov Identifier: NCT04119180
• Recruitment Status: Recruiting
• First Posted: October 8, 2019
• Last Update Posted: March 3, 2020
• Sponsor: Universidade Federal de Goias
• Collaborators: University of Sao Paulo; King's College London
• Information provided by (Responsible Party): Luciane Ribeiro de Rezende Sucasas da Costa, Universidade Federal de Goias

Tracking Information

• First Submitted Date: October 1, 2019
• First Posted Date: October 8, 2019
• Last Update Posted Date: March 3, 2020
• Actual Study Start Date: January 30, 2020
• Estimated Primary Completion Date: December 15, 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: October 4, 2019)

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).

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: October 4, 2019)

• 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
• 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).
• 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).
• 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
• 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
• 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
• 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
• 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
• 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
• 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).
• 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
• 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
• 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
• 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
• 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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Non-Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Child Behavior
• Dental Caries in Children

Intervention

• Drug: Ketamine 50 MG/ML
  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 Name: Ketamin S, Cristalia, São Paulo, Brazil
• Drug: Midazolam Hcl 2Mg/Ml Syrup
  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 Name: Dormire oral solution, Cristalia, Sao Paulo, Brazil
• Procedure: Protective stabilization
  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 Arms

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

  • Drug: Ketamine 50 MG/ML
  • Drug: Midazolam Hcl 2Mg/Ml Syrup
• 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.
  Intervention: Procedure: Protective stabilization

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: October 4, 2019): 152
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 31, 2022
• Estimated Primary Completion Date: December 15, 2021 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 1 Year to 7 Years (Child)
• Accepts Healthy Volunteers: Yes

Contacts

Contact: Luciane RS Costa, PhD; +556232096325; lsucasas@ufg.br

Contact: Paulo SS Costa, PhD; +556232096151; paulosucasas@ufg.br

• Listed Location Countries: Brazil

Administrative Information

• NCT Number: NCT04119180
• Other Study ID Numbers: PI03925-2019; 424339/2018-8 ( Other Grant/Funding Number: CNPq )
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Yes
• Supporting Materials: Study Protocol
• Supporting Materials: Informed Consent Form (ICF)

• Responsible Party: Luciane Ribeiro de Rezende Sucasas da Costa, Universidade Federal de Goias
• Study Sponsor: Universidade Federal de Goias

Collaborators

• University of Sao Paulo
• King's College London

Investigators

• Principal Investigator: Luciane RS Costa, PhD; Universidade Federal de Goias
• Study Director: Daniela P Raggio, PhD; University of Sao Paulo

• PRS Account: Universidade Federal de Goias
• Verification Date: March 2020