Clinical trial
Aesthetic Restorations in Deciduous Anterior Teeth - Study Protocol for a Randomized Clinical Trial
Name
RehabAnteriorUnimes
Description
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.
Trial arms
Trial start
2023-08-01
Estimated PCD
2025-07-30
Trial end
2025-07-30
Status
Not yet recruiting
Phase
Early phase I
Treatment
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.
Arms:
polyvinyl crown - experimental group
Restoration with conventional resin composite
Restorative treatment of anterior primary teeth with conventional composite resin, after selective removal of carious tissue
Arms:
conventional restoration group (control)
Size
194
Primary endpoint
Change in progression of caries lesion through clinical criteria and longevity of restorations
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This is a non-inferiority randomized clinical trial with parallel arms, with an allocation ratio of 1:1', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 194, 'type': 'ESTIMATED'}}
Updated at
2023-05-25
1 organization
1 product
1 indication
Organization
University of Nove de JulhoIndication
Dental Caries in Children