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Not yet recruiting NCT05875064

Aesthetic Restorations in Deciduous Anterior Teeth

Phase III Interventional Dental Caries in Children

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Restoration with resin composite and polyvinyl crown, Restoration with conventional resin composite.
Who it may be relevant to
Registry conditions: Dental Caries in Children. Basic parameters: 12 months — 60 months · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Aesthetic Restorations in Deciduous Anterior Teeth - Study Protocol for a Randomized Clinical Trial

Overview

This study proposes to conduct a randomized clinical trial (RCT), composed of a sample of 194 deciduous central and lateral incisors with active cavitated lesions, simplified ICDAS C+ score, 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 monochromatic resin with chameleon effect and polyvinyl crowns.

Interventions

  • Combination product Restoration with resin composite and polyvinyl crown
    Restorative treatment of anterior primary teeth with monochromatic composite resin in single insertion through polyvinyl crowns, after selective removal of carious tissue compared to the effectiveness of conventional restoration.
  • Procedure Restoration with conventional resin composite
    Restorative treatment of anterior primary teeth with conventional composite resin, after selective removal of carious tissue

Primary outcome measures

  • Change in progression of caries lesion through clinical criteria and longevity of restorations [Time frame: Baseline and after 6, 12, 18 and 24 months.]
Secondary outcome measures (4)
  • Change in the progression of caries lesion by radiographic criteria [Time frame: Baseline and after 6, 12, 18 and 24 months.]
  • Change in the perception of parents/guardians [Time frame: Baseline and after 6, 12, 18 and 24 months.]
  • Change in the satisfaction of parents/guardians [Time frame: Baseline and after 6, 12, 18 and 24 months.]
  • Change in the impact of treatments on children's oral health-related quality of life [Time frame: Baseline and after 6, 12, 18 and 24 months.]

Eligibility criteria

Inclusion criteria

  • Children ranging in age from 12 to 60 months with at least one active cavitated caries lesion involving more than 2 surfaces (C+ score) in deciduous upper incisors will be included.

Exclusion criteria

  • Patients with special needs, with general health conditions that may affect the oral cavity, whose guardians do not sign the Inform Consent Form will be excluded. In addition, teeth with pulp exposure, spontaneous pain, mobility, presence of swelling or fistula near the tooth and teeth with previous restorations; less than 2/3 of root (radiographically assessed), teeth without an antagonist, teeth with previous restorations and children with bruxism and/or deep bite.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Publications

  • Gimenez T, Sobral APT, Santos EM, Goncalves MLL, Ferri EP, Gallo JMAS, Horliana ACRT, Motta LJ, Imparato JCP, Bussadori SK. 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. BMJ Open. 2025 Feb 6;15(2):e086200. doi: 10.1136/bmjopen-2024- PMID 39915031

Identifiers

NCT: NCT05875064 · RehabAnteriorUnimes

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗