NCT02389569

Brief Summary

This study aimed to evaluate the clinical performance of a novel vitro-ceramic biomaterial (Biosilicate®) as treatment of caries-affected dentin in posterior resin restorations. A total of 94 restorations of 66 participants were selected and assigned at random into four groups: 1 (Biosilicate / Two-step etch and rinse system), 2 (Control / Two-step etch and rinse system), 3 (Biosilicate / Two-step self-etching system) and 4 (Control / Two-step self-etching system). Two operators carried out the adhesive protocols and restored the cavities with a nano-hybrid resin composite (IPS Empress, Ivoclar) using the incremental technique. Participants were recalled at one week, 6, 12 and 18 months for clinical evaluation performed by two blinders and calibrated examiners according FDI criteria.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 24, 2015

Completed
21 days until next milestone

First Posted

Study publicly available on registry

March 17, 2015

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
Last Updated

April 13, 2017

Status Verified

April 1, 2017

First QC Date

February 24, 2015

Last Update Submit

April 11, 2017

Conditions

Dental Caries

Keywords

BiomaterialDental cariesComposite

Outcome Measures

Primary Outcomes (1)

  • Clinical performance of Biosilicate in caries lesion using FDI evaluation criteria

    Two experienced and calibrated dentists, not involved with the placement of the restorations will be assess the efficiency of Biosilicate under composite restoration of Class I and Class II dentin caries lesions by record instrument to record the esthetic, functional and biological properties over a 18 months time frame. These variables will be ranked according to the FDI criteria in the following scores: clinically very good, clinically good, clinically sufficient/ satisfactory, clinically unsatisfactory and clinically poor.

    18 months

Study Arms (2)

Adhesive system treatment

EXPERIMENTAL

Four groups ( Two will be treat with Etch-and-Rinse Adhesive System and two will be treated with two step Self-Etch Adhesive System).

Procedure: Adhesive system

Restoration protocol

EXPERIMENTAL

Four groups ( Two will be treat with experimental Biosilicate and two will be the control groups).

Procedure: Restoration protocol

Interventions

Adhesive systemPROCEDURE

Etch-and-rinse and Self-etch adhesive system will be applied in volunteers that received different types of restoration protocol.

Also known as: Etch-and-rinse adhesive: Adper Single bond (3M, Brazil), Self-etch: Adhese (2 step self-etch) (Ivoclar, Vivadent)
Adhesive system treatment
Restoration protocolPROCEDURE

Volunteers will be treated by two types of protocol restoration : 1) Biosilicate (powder) or 2) Control (without Biosilicate). In sequence, adhesive (self-etch or etch and rinse) and composite resin will be used for restoration.

Also known as: Biosilicate (Vitrovita, Brazil), Control
Restoration protocol

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Cavitated or non-cavitated active carious lesions in dentin (Class I and/or II)
  • Carious lesion in teeth with or without restoration in at least one tooth (upper or lower premolar and/or molar).
  • No history of spontaneous pain
  • Pulp vital tests positive
  • No evidence of periapical radiolucency

You may not qualify if:

  • Compromised medical history
  • Periodontal disease
  • Pulp necrosis
  • Absence of antagonist teeth
  • Severe bruxism
  • Active orthodontic treatment
  • Teeth with cracks and premature contact.
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Sao Paulo, Ribeirao Preto Campus

Ribeirão Preto, São Paulo, 14040-904, Brazil

Location

Related Links

MeSH Terms

Conditions

Dental Caries

Interventions

inzomaVivadentsodium oxide-calcium oxide-silicon dioxide-diphosphorus pentoxide

Condition Hierarchy (Ancestors)

Tooth DemineralizationTooth DiseasesStomatognathic Diseases

Study Officials

  • Karen Pintado Palomino, MSc

    University of Sao Paulo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MSc

Study Record Dates

First Submitted

February 24, 2015

First Posted

March 17, 2015

Primary Completion

August 1, 2016

Last Updated

April 13, 2017

Record last verified: 2017-04

Locations

BR(1)