Ethical and Legal Aspects of Informed Consent and Assent in Paediatric Dentistry: A Cross-Sectional Study

Abstract

Highlights: What are the main findings? Children received information on diagnosis, treatment and benefits consistently, but key elements such as risks, alternatives and the right to withdraw consent were often omitted. Child schooling level—not caregiver education—was the strongest independent predictor of receiving more complete information within the consent process. What are the implications of the main findings? Standardised consent and assent protocols are needed to ensure that all paediatric patients, regardless of age or schooling, receive comprehensive and ethically adequate information. Enhancing bioethical and communication training for dental students may improve the consistency and quality of informed consent practices in paediatric dentistry. Background: Informed consent and assent are fundamental ethical and legal requirements in paediatric healthcare, yet their application in paediatric dentistry is complex and underexplored in clinical practice. Objective: This study aimed to analyse the implementation of informed consent and assent processes in paediatric dental care within a Spanish population, identifying key characteristics and factors that influence communication, understanding, and decision-making. Methods: An observational, descriptive, cross-sectional study was conducted in Spanish Paediatric Dentistry Clinics (January–June 2023). Participants included 520 child-caregiver pairs and 52 dental students. Data were collected via a semi-structured observational protocol and interviews, assessing information provided, decision-making conditions, and influencing factors. Statistical analysis was performed using SPSS v23.0, employing Chi-square, Cochran’s Q, and Kendall’s W tests. Results: The information most frequently provided was the nature of the dental problem (92%), treatment details (88%), and benefits (85%). Information on risks (64%), alternatives (37%), and the right to withdraw consent (41%) was less consistently communicated. After multivariable adjustment, child schooling remained independently associated with the disclosure of risks and alternatives (p < 0.01), whereas caregiver education showed no independent effect. Kendall’s concordance coefficient showed moderate agreement (W = 0.62, 95% CI: 0.54–0.69, p < 0.01) among operators, caregivers, and patients, which decreased in adolescents aged 16–18 years (W = 0.41, 95% CI: 0.28–0.55, p = 0.07). Conclusions: The processes of informed consent and assent in paediatric dentistry are more strongly linked to the child’s cognitive maturity and schooling than to parental education. While communication of treatment benefits is adequate, critical aspects like risks and alternatives are often overlooked. The findings underscore the need for standardized protocols and enhanced bioethical training to ensure consistent, ethical, and participatory practices that respect the progressive autonomy of minors.