Chewable Tablets Produced by Three-Dimensional Printing: A Sensory Acceptability Study in Children and Adolescents (ACEITA3D)

February 20, 2026 updated by: Marcílio Sérgio Soares da Cunha Filho, University of Brasilia
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.

Study Overview

Status

Not yet recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

100

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Children and adolescents receiving care at the Nutrition Outpatient Clinic of the Hospital da Criança de Brasília José Alencar.

Description

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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).
  • Refusal of the child/adolescent or legal guardian to participate in the study at any time, even after prior consent has been provided.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensory acceptability score (5-point facial hedonic scale)
Time Frame: Immediately after tablet administration (single assessment per stage)
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.
Immediately after tablet administration (single assessment per stage)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Brasilia

Collaborators

Hospital da Criança de Brasília José Alencar

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2027

Primary Completion (Estimated)

March 1, 2028

Study Completion (Estimated)

December 1, 2028

Study Registration Dates

First Submitted

February 13, 2026

First Submitted That Met QC Criteria

February 13, 2026

First Posted (Actual)

February 20, 2026

Study Record Updates

Last Update Posted (Actual)

February 24, 2026

Last Update Submitted That Met QC Criteria

February 20, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • ACEITA3D

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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