Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE3
194 participants
INTERVENTIONAL
2025-01-26
2026-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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conventional restoration group (control)
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).
Restoration with conventional resin composite
Restorative treatment of anterior primary teeth with conventional composite resin, after selective removal of carious tissue
polyvinyl crown - experimental group
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).
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.
Interventions
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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.
Restoration with conventional resin composite
Restorative treatment of anterior primary teeth with conventional composite resin, after selective removal of carious tissue
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
12 Months
60 Months
ALL
No
Sponsors
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University of Nove de Julho
OTHER
Responsible Party
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Sandra Kalil Bussadori
Principal Investigator
Central Contacts
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References
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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-2024-086200.
Other Identifiers
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RehabAnteriorUnimes
Identifier Type: -
Identifier Source: org_study_id
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