ArticleBMC oral health2021
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.
Article in BMC oral health, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04119180 (Sedation Versus Protective Stabilization for Dental Treatment of Children With Caries and Negative Behavior at the Dentist), which is not on this map. Cited by 7 papers, 1 of them a synthesis that pooled it.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Sedation Versus Protective Stabilization for Dental Treatment of Children With Caries and Negative Behavior at the Dentist: a Non-randomized Clinical Trial
Who cites it
7 citing papers in PubMed, 1 synthesis or guideline pooled it, 11 citations in OpenAlex.
- Efficacy of Midazolam in Outpatient Pediatric Dentistry: A Systematic Review.Special care in dentistry : official publication of the American Association of Hospital Dentists, the Academy of Dentistry for the Handicapped, and the American Society for Geriatric DentistryPooled it
- Comparison of Parental Perceptions and Oxygen Saturation Response to Papoose Board and Comfy Wrap Restraints in Pediatric Dental Procedures: A Crossover Study.International journal of clinical pediatric dentistry · 2026Article
- Comparative evaluation of the sedative efficacy of oral midazolam (0.5 mg/kg vs. 0.75 mg/kg) with papoose board restraint for managing severe dental anxiety in paediatric patients: a retrospective cohort study.BMC anesthesiology · 2026Article
- Evaluation of Efficiency of Different Sedation Procedures in Pediatric Dental Procedures: A Clinical Study.Journal of pharmacy & bioallied sciences · 2025Article
- Effect of Midazolam Premedication on Salivary Cortisol Levels in Pediatric Patients with Negative Frankl Behavior: A Pilot Study.Children (Basel, Switzerland) · 2025Article
- Non-pharmacological Behavior Management Techniques in Pediatric Dentistry: A Bibliometric Analysis.Cureus · 2023Review
- Held still or pressured to receive dental treatment: self-reported histories of children and adolescents treated by non-specialist dentists in Hordaland, Norway.European archives of paediatric dentistry : official journal of the European Academy of Paediatric Dentistry · 2022Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
11 authors at 4 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThere is a lack of evidence on the effectiveness of moderate sedation in pediatric dentistry, compared to protective stabilization, which remains routinely used in Brazil despite moral questions. This prospective non-randomized clinical trial's objective is to evaluate the effectiveness of moderate sedation, compared to the protective stabilization, in the dental care of children with dental behavior management problems.
methodsParticipants will be 152 children under seven years of age with early childhood caries (ECC) who need specialized dental treatment due to a history of challenging behavior during dental care. The interventions to be compared are moderate sedation with oral administration of ketamine and midazolam and protective stabilization. The primary endpoint will be the child's behavior during treatment assessed using the Ohio State University Behavioral Rating Scale (OSUBRS). The secondary outcomes are (A) child's - behavior according to the visual analogue scale, anxiety, pain, and physiological stress; (B) parent's - satisfaction and anxiety; (C) family and child - impact on oral health-related quality of life (OHRQoL); (D) dentist's - satisfaction and stress; (E) procedure - adverse events of the intervention and dental treatment longevity. A cost-effectiveness analysis will be performed from the perspective of the Brazilian Unified Health System (SUS). DISCUSSION: Considering the primary outcome, this study hypothesis is that sedated children have better behavior during dental treatment than children whose behavior was managed by protective stabilization without sedation. Additionally, at the end of 12 months, we expect to identify participants' reported outcomes and objective measures related to dental behavior in early childhood. Trial registration Clinicaltrials.gov registration NCT04119180 on October 8th, 2019. https://clinicaltrials.gov/ct2/show/NCT04119180.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.