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NCT05875064 | NOT YET RECRUITING | Dental Caries in Children

Aesthetic Restorations in Deciduous Anterior Teeth
Sponsor:

University of Nove de Julho

Information provided by (Responsible Party):

Sandra Kalil Bussadori

Brief Summary:

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.

Condition or disease

Dental Caries in Children

Intervention/treatment

Restoration with resin composite and polyvinyl crown

Restoration with conventional resin composite

Phase

PHASE3

Study Type : INTERVENTIONAL
Estimated Enrollment : 194 participants
Masking : SINGLE
Primary Purpose : TREATMENT
Official Title : Aesthetic Restorations in Deciduous Anterior Teeth - Study Protocol for a Randomized Clinical Trial
Actual Study Start Date : 2025-01-26
Estimated Primary Completion Date : 2026-11-30
Estimated Study Completion Date : 2026-11-30

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 12 Months to 60 Months
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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.
Aesthetic Restorations in Deciduous Anterior Teeth

Location Details

NCT05875064

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How to Participate

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Locations

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