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Evaluation of an Injectable Bioactive Restorative Material in children's molar teeth

Evaluation of Injectable Bioactive Composite for Posterior Restoration in deciduous teeth: randomized split-mouth clinical trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-6b7b6tt
Enrollment
Unknown
Registered
2022-10-17
Start date
2022-08-22
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dental caries

Interventions

The teeth of each patient will be randomly distributed in two groups (n=40) according to the restorative treatment to be used: 1) restoration with injectable bioactive composite and 2) restoration wit
03.07.01.008-2

Sponsors

Faculdade de Odontologia de Ribeirão Preto, Universidade de São Paulo (FORP-USP)
Lead Sponsor
Faculdade de Odontologia de Ribeirão Preto, Universidade de São Paulo (FORP-USP)
Collaborator

Eligibility

Age
4 Years to 8 Years

Inclusion criteria

Inclusion criteria: The inclusion criterion will be that the patient must be between 4 and 8 years old; and have at least 2 homologous deciduous molars with caries lesions or fractures affecting only the occlusal or occlusal-proximal surfaces

Exclusion criteria

Exclusion criteria: Teeth with extensive structural loss requiring indirect restorations; endodontic treatment or indication for extraction; teeth with acute painful symptoms such as pulpitis or pericementitis; teeth with structural defects such as Molar-Incisor Hypomineralisation or Amelogenesis Imperfecta; children with parafunctional habits such as child bruxism

Design outcomes

Primary

MeasureTime frame
Evaluate the clinical behavior of an injectable single increment bioactive composite in deciduous molar restorations with the criteria approved by the World Dental Federation (FDI Criteria), at 1 week, 6 months and 12 months after restorations.

Secondary

MeasureTime frame
Evaluate the survival curve of the restorations during the study period.

Countries

Brazil

Contacts

Public ContactRafaela Manente

Faculdade de Odontologia de Ribeirão Preto, Universidade de São Paulo (FORP-USP)

rafaela.manente@usp.br+55 (16) 33153953

Outcome results

None listed

Source: REBEC (via WHO ICTRP)