Sedation Versus Protective Stabilization for Dental Treatment of Children With Caries and Negative Behavior at the Dentist: a Non-randomized Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 152
- 试验地点
- 2
- 主要终点
- Child behavior during the dental treatment
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 1 Year 至 7 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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)
排除标准
- •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
研究组 & 干预措施
Sedation
The child receives sedatives approved for use in an outpatient setting, directed by a doctor, to accomplish the dental treatment.
干预措施: Ketamine 50 MG/ML (Drug)
Sedation
The child receives sedatives approved for use in an outpatient setting, directed by a doctor, to accomplish the dental treatment.
干预措施: Midazolam Hcl 2Mg/Ml Syrup (Drug)
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.
干预措施: Protective stabilization (Procedure)
结局指标
主要结局
Child behavior during the dental treatment
时间窗: 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).
次要结局
- Parental satisfaction with the intervention(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(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(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(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(Duration of the dental session, an expected average of 40 minutes)
- Progression of child behavior throughout the follow-up(Baseline (dental examination) plus follow-up sessions at 4, 8, and 12 months post-treatment)
- Progression of child dental anxiety throughout the follow-up(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(Baseline (dental examination) plus follow-up sessions at 4, 8, and 12 months post-treatment)
- Child pain reported by the parent(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(At the end of each session from dental examination through the end of the dental treatment, an average of 2 months)
- Adverse events during the dental procedure(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(End of each session of dental treatment, an average of 2 months)
- Longevity of composite resin and glass ionomer cement restorations(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))
- Children's stress according to salivary cortisol(Change from baseline in the salivary cortisol at an expected average of 40 minutes)
- Cost analysis(An expected average of 15 months)
研究者
Luciane Ribeiro de Rezende Sucasas da Costa
Professor
Universidade Federal de Goias