Sedation Versus Protective Stabilization for Pediatric Dental Treatment

Официальное название

Sedation Versus Protective Stabilization for Dental Treatment of Children With Caries and Negative Behavior at the Dentist: a Non-randomized Clinical Trial

Обзор

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.

Вмешательства

• Препарат 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
• Препарат 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;
• Процедура 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.

Первичные конечные точки

• Child behavior during the dental treatment [Срок оценки: Participants will be followed for the duration of the dental session, an expected average of 40 minutes]

Вторичные конечные точки (12)

• Progression of child behavior throughout the follow-up [Срок оценки: Baseline (dental examination) plus follow-up sessions at 4, 8, and 12 months post-treatment]
• Progression of child dental anxiety throughout the follow-up [Срок оценки: 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 [Срок оценки: Baseline (dental examination) plus follow-up sessions at 4, 8, and 12 months post-treatment]
• Parental satisfaction with the intervention [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: Duration of the dental session, an expected average of 40 minutes]
• Adverse events during the dental procedure [Срок оценки: 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 [Срок оценки: End of each session of dental treatment, an average of 2 months]

Критерии участия

Критерии включения

• 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)

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Бразилия · 2 центра

• Dental School - UFG — Goiânia
• Dental School - FOUSP — São Paulo

Публикации

• 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 PMID 33980232

Идентификаторы

NCT: NCT04119180 · PI03925-2019 · 424339/2018-8

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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