Sedation Versus Protective Stabilization for Pediatric 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).

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

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).

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).

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

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

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

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

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

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

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).

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

Restored teeth count at the end of each session

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

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-efficacy of different sedation protocols according to the methodology of health technologies assessment; the cost of each intervention will be compared