Chewable Tablets Produced by Three-Dimensional Printing: A Sensory Acceptability Study in Children and Adolescents
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age3-18
SponsorUniversity of Brasilia
About this trial
The lack of appropriate pediatric formulations compromises adherence and the effectiveness of oral treatment in children, mainly due to the splitting of adult tablets and low sensory acceptability. This observational, analytical, and cross-sectional study aims to evaluate the acceptability of a novel pediatric dosage form consisting of placebo chewable tablets produced by 3D printing, with a focus on palatability and feasibility for dose personalization. Children and adolescents aged 3 to 18 years receiving care at the Nutrition Outpatient Clinic of the Hospital da Criança de Brasília José Alencar will be invited to participate. The study will be conducted in two stages. In the first stage, acceptability of a bear-shaped chewable tablet will be assessed, as well as preference among different flavors. In the second stage, preference for chewable tablets with or without xylitol will be investigated, in addition to dysgeusia associated with diseases or chronic medication use. Acceptability will be measured using a 5-point facial hedonic scale, evaluator observation, and age-appropriate questionnaires. The study is expected to identify the most accepted flavors and sweetness intensities, as well as to evaluate the acceptability of the 3D-printed dosage form, contributing to the development of safer, more attractive, and personalized pediatric medicines.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Children and adolescents aged 3 to 18 years receiving care at the Nutrition Outpatient Clinic of the Hospital da Criança de Brasília José Alencar (HCB).
Written informed consent provided by the legal guardian through the signing of the Informed Consent Form (ICF).
Assent from the child or adolescent, when applicable, expressed through the signing of the Informed Assent Form (IAF).
Disqualifiers
Children or adolescents with dietary restrictions or known allergies to any component present in the formulations used in the study.
Children or adolescents with glucose-6-phosphate dehydrogenase (G6PD) deficiency.
Children or adolescents diagnosed with severe neurological, cognitive, or behavioral disorders that impair communication, comprehension, or response to the sensory scale.
Oral conditions, mucosal lesions, or dysphagia that prevent or significantly impair proper chewing or swallowing of the tablet (e.g., mucositis).
Trial population
Children and adolescents receiving care at the Nutrition Outpatient Clinic of the Hospital da Criança de Brasília José Alencar.
Trial design
Design model
Other
Time perspective
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Sensory acceptability score (5-point facial hedonic scale)
Sensory acceptability will be assessed using a 5-point Facial Hedonic Scale ranging from 1 (disliked very much) to 5 (liked very much), with higher scores indicating better acceptability.
Time frame
Immediately after tablet administration (single assessment per stage)Locations
Sponsors and contacts
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University of Brasilia
Lead sponsor
Hospital da Criança de Brasília José Alencar
Collaborator
Source ClinicalTrials.gov
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