Table 1 Secondary outcomes and their respective analysis metrics
Secondary outcome | Participant level analysis metrics | Aggregation method | Measurement time |
|---|---|---|---|
Child behavior, according to the dentist | 10 cm Visual Analogue Scale (VAS) | Scores (ordinal scales) | Per session: First consultation, treatment sessions, follow-up sessions of 4, 8, and 12 months |
Child anxiety | Facial Image Scale (FIS) | Scores (ordinal scale) | Per session: First consultation, treatment sessions, follow-up sessions of 4, 8, and 12 months |
Oral health-related quality of life | The Brazilian version of Early Childhood Oral Health Impact Scale (B-ECOHIS) [18] | Scores (ordinal scale) | Per session: First consultation, follow-up sessions of 4, 8, and 12 months |
Parents' satisfaction and anxiety | 10 cm VAS | Scores (ordinal scale) | At the end of each session |
Dentist's satisfaction and stress | 10 cm VAS | Scores (ordinal scale) | At the end of each session |
Child pain perceived by the dentist | 10 cm VAS | Scores (ordinal scale) | At the end of each session |
Child pain/distress according to observational scale | Observational scale "The Faces, Legs, Activity, Cry and Consolability" Pain Assessment Tool, Brazilian version—FLACC [19] | Score (ordinal scale) | At the end of the first treatment session (evaluation performed using the digital recording of the session) |
Adverse events for sedated participants | Research instrument Tracking and Reporting Outcomes of Procedural Sedation TROOPS [20] | Frequency | During sedation and recovery |
Unfavorable signs (protective stabilization) | Specific form | Frequency | Shortly after the dental procedure |
The longevity of composite resin and glass ionomer cement restorations | Criteria for evaluation of occlusal [21] or occlusoproximal restorations [22] | Frequency (grouped categories in success/failure) | After the intervention, follow-up sessions of 4, 8, and 12 months |
Child physiological stress | Salivary cortisol concentration, in mg/dL | Variation in cortisol levels during dental treatment (area under the curve) | Per session, at pre-determined moments: at arrival at the treatment session, 25 min after the end of the procedure |