CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 38 enrolled
Drug / intervention
G1-Control: Futurabond®DC-SE (FBDC_SE) +5 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02698371
NCT02698371N/ACompleted

NCCL Direct Composite Restoration Performance With Self-Etch and Multimode Adhesives Clinical Trial

University Fernando Pessoa·interventional·Posted Mar 3, 2016·Updated Sep 13, 2019

In Brief

A clinical study evaluating G1-Control: Futurabond®DC-SE (FBDC_SE), G2-Control: Futurabond®DC_SE_EE, and 4 other interventions for Dental Adhesives/Restorations Performance. Completed, enrolled 38 participants across 1 site.

Detailed Summary

The purpose is to evaluate/compare clinical effectiveness of dual cure (DC) all-in-one Self-Etch (Futurabond® DC (FBDC)) adhesive and multimode/universal (Futurabond® U (FU) and Adhese® Universal (AU)) adhesives, with or without selective enamel etching, in non-carious cervical lesions (NCCL), during 24th months, using Word Dental Federation (FDI) and United States Public Health Services (USPHS) criteria. The null hypotheses are: H0 - Bonding to NCCLs with DC-SE and SE-Universal adhesives with SE strategies will result in similar (no significant differences) clinical (aesthetic, functional and biologic) behaviour/performance in a period of 24th month evaluation; H0 - Bonding to NCCLs with DC-SE and SE-Universal adhesives with SE strategies will result in similar restorations (aesthetic, functional and biologic) success rates over 24th month evaluation; H0 - Bonding to NCCLs with DC-SE and SE-Universal adhesives with SE strategies will result in similar restoration retention rates in a period of 24th month evaluation; H0 - Bonding to NCCLs DC-SE with enamel pre-etching and Universal adhesives with ER adhesive strategy will result in similar (no significant differences) clinical (aesthetic, functional and biologic) behaviour/performance in a period of 24thmonth evaluation; H0 - Bonding to NCCLs DC-SE with enamel pre-etching and Universal adhesives with ER adhesive strategy will result in similar restorations (aesthetic, functional and biologic) success rates over 24th month evaluation; H0 - Bonding to NCCLs DC-SE with enamel pre-etching and Universal adhesives with ER adhesive strategy will result in similar restoration retention rates in a period of 24th month evaluation; H0 - Bonding to NCCLs with FBDC or FU (DC adhesives) and AU (Light-curing adhesive) with SE or ER adhesive strategies will result in similar (no significant differences) clinical (aesthetic, functional and biologic) behaviour/performance in a period of 24th month evaluation; H0 - Bonding to NCCLs with FBDC or FU (DC adhesives) and AU (Light-curing adhesive) with SE or ER adhesive strategies will result in similar restorations (aesthetic, functional and biologic) success rates over 24th month evaluation; H0 - Bonding to NCCLs with FBDC or FU (DC adhesives) and AU (Light-curing adhesive) with SE or ER adhesive strategies will result in similar restoration retention rates in a period of 24th month evaluation; H0 - FDI or USPHS criteria evaluation outcomes not differ for the same data.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesPortugal
Collaborators--

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedMar 3, 2016
Enrollment StartNov 1, 2015
Primary CompletionMay 1, 2018
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 10.3 years ago

Interventions

G1-Control: Futurabond®DC-SE (FBDC_SE)device

Futurabond®DC (FBDC) adhesive by self-etch (SE) mode bonding in NCCls restorations, was randomly assigned to premolar or molar teeth ensuring that this adhesive/mode is only apllied once in each participant.

G2-Control: Futurabond®DC_SE_EEdevice

Futurabond®DC adhesive by self-etch mode with selective enamel etching (FBDC-SE-EE) bonding in NCCls restorations, was randomly assigned to premolar or molar teeth ensuring that this adhesive/mode is only apllied once in each participant.

G3: Futurabond® U - ER (FBU_ER)device

FuturabondU® (FBU) adhesive by etch-and-rinse (ER) mode, bonding in NCCls restorations, was randomly assigned to premolar or molar teeth ensuring that this adhesive/mode is only apllied once in each participant.

G4: Futurabond® U - SE (FBU_SE)device

FuturabondU® (FBU) adhesive by self-etch (SE) mode, bonding in NCCls restorations, was randomly assigned to premolar or molar teeth ensuring that this adhesive/mode is only apllied once in each participant.

G5: Adhese® Universal - ER (ADU_ER)device

Adhese®Universal (ADU) adhesive by etch-and-rinse (ER) mode, bonding in NCCls restorations, was randomly assigned to premolar or molar teeth ensuring that this adhesive/mode is only apllied once in each participant.

G6: Adhese® Universal - SE (ADU_SE)device

Adhese®Universal (ADU) adhesive by self-etch (SE) mode, bonding in NCCls restorations, was randomly assigned to premolar or molar teeth ensuring that this adhesive/mode is only apllied once in each participant.