An Investigator-blinded, 24-month, Parallel-group, Non-inferiority Study to Compare Aesthetic Restorations in Primary Anterior Teeth in a Paediatric Dental Clinic: Study Protocol for a Randomised Controlled Trial

Introduction: Children who suffer from severe caries in childhood may have negative impacts on the growth, development, nutritional problems and quality-of-life problems related to the oral health of the child and their family. There are no studies that have compared rehabilitative techniques of primary anterior teeth regarding patient-centred outcomes and even longevity of the restoration. Thus, this project aims to evaluate the effectiveness of restorative treatment of anterior primary teeth with monochromatic composite resin in single insertion through polyvinyl crowns, after selective removal of carious tissue compared with the effectiveness of conventional restoration.

Methods And Analysis: This study proposes to conduct a randomised clinical trial, composed of a sample of 194 deciduous central and lateral incisors with active cavitated lesions, simplified International Caries Detection and Assessment System (ICDAS) C+ score (active and extensive stage caries: ICDAS 5 and 6), with involvement of more than two surfaces. This sample will be divided into two experimental groups, both with selective removal of carious tissue: a group in which conventional restoration will be performed using opaque resins, and another group with monochrome resin with chameleon effect and polyvinyl crowns. The explanatory variables-gender, age, toothbrushing, use of fluoridated toothpaste and dental floss, and socioeconomic status-will be collected through a questionnaire with open questions. The progression of caries lesions after 24 months of follow-up will be considered as the primary outcome. Secondary outcomes will include tooth survival, longevity of restoration, quality of life, perception and satisfaction of the participants' parents/guardians.

Ethics And Dissemination: This protocol has been approved by the Human Research Ethics Committee of Universidade Metropolitana de Santos (protocol number: 6.019.297. Approved 24 April 2023). Results will be submitted to international peer-reviewed journals and presented at international conferences.

Trial Registration Number: NCT05875064.