Aesthetic Restorations in Deciduous Anterior Teeth

University of Nove de Julho

Status and phase: Not yet enrolling; Phase 3

Conditions: Dental Caries in Children

Treatments: Combination Product: Restoration with resin composite and polyvinyl crown; Procedure: Restoration with conventional resin composite

Study type: Interventional

Funder types: Other

Identifiers

NCT05875064

RehabAnteriorUnimes

Details and patient eligibility

About

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.

Enrollment: 194 estimated patients

Sex: All

Ages: 12 to 60 months old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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194 participants in 2 patient groups

conventional restoration group (control)

Active Comparator group

Description:

The teeth allocated in the conventional restoration group (control) will receive restorations in resin composed by incremental technique, using opaque resin. For this, 37% phosphoric acid (Condac37, FGM) will be applied for 15 seconds, and then, after washing and relative drying of the surface, application of universal adhesive (Universal Beautibond Adhesive, Shofu) with the aid of microbrush on the entire dental surface, photoactivation of the adhesive and restoration by incremental technique and photoactivation of each layer of resin for 20 seconds. The tooth will receive finishing and polishing through rotating instruments and abrasive discs (Supersnap, Shofu).

Treatment:

Procedure: Restoration with conventional resin composite

polyvinyl crown - experimental group

Experimental group

Description:

The teeth allocated in the experimental group will have the restorations carried out through monochromatic composite resin with chameleon effect in single insertion through polyvinyl crown. For this, 37% phosphoric acid (Condac37, FGM) will be applied for 15 seconds, and then, after washing and relative drying of the surface, application of universal adhesive (Universal Beautibond Adhesive, Shofu) with the aid of microbrush on the entire tooth surface, photoactivation of the adhesive and adaptation of the crown matrix in acetate filled with resin in the tooth. Photoactivation will be done for 20 seconds per dental face, and the acetate matrix is then removed. The tooth will receive finishing and polishing through rotating instruments and abrasive discs (Supersnap, Shofu).

Treatment:

Combination Product: Restoration with resin composite and polyvinyl crown