Evaluation of the Reduced Dentin Etching Time Using Universal Adhesives in the Quality of Cervical Lesions Restorations

NCT06465849 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2024-06-20

No results posted yet for this study

Summary

The aim of this study will be to evaluate the effect of reduced dentin etching time on the 6- and 12-months clinical performance of two universal adhesive systems used as etch-and-rinse application mode in non-carious cervical lesions (NCCLs).

Materials \& Methods: 140 restorations will be randomly placed in 35 subjects according to the following groups: SUP5 (Scotchbond Universal Plus adhesive on dentin etched for 5 seconds); SUP15 (Scotchbond Universal Plus adhesive on dentin etched for 15 seconds); GBU5 (Gluma Universal Bond adhesive on dentin etched for 5 seconds); GBU15 (Gluma Universal Bond adhesive on dentin etched for 15 seconds). All groups will be light-cured for 10s/1,000 mW/cm2. A resin composite will be placed by applying three increments and each one will be light cured for 20s/1,000 mW/cm2. The restorations will be finished immediately with fine diamond burs and polishers. The restorations will be evaluated at baseline and after 6- and 12-months by using the FDI criteria. The following outcomes will be evaluated: retention, marginal staining, marginal adaptation, post-operative sensitivity and recurrence of caries. The differences among the groups will be calculated using Friedman repeated measures analysis of variance rank (α = 0.05).

Conditions

  • Non-carious Cervical Lesions

Interventions

PROCEDURE

Dentin Etching time for 5 seconds

Composite resin restorations of non-carious cervical lesions will be performed with an adhesive on dentin etched for 5 seconds in the etch-and-rinse application strategy.

DEVICE

Scotchbond Universal Plus; 3M

Composite resin restorations of non-carious cervical lesions will be performed with an universal adhesive (Scotchbond Universal Plus; 3M).

DEVICE

Gluma Universal Bond; Kulzer

Composite resin restorations of non-carious cervical lesions will be performed with an universal adhesive (Gluma Universal Bond; Kulzer).

PROCEDURE

Dentin Etching time for 15 seconds

Composite resin restorations of non-carious cervical lesions will be performed with an adhesive on dentin etched for 15 seconds in the etch-and-rinse application strategy.

Sponsors & Collaborators

  • Agencia Nacional de Investigación y Desarrollo

    collaborator OTHER
  • Universidad de los Andes, Chile

    lead OTHER

Principal Investigators

  • Mario Felipe Gutiérrez Reyes, PhD · Universidad de los Andes, Chile

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-03-30
Primary Completion
2024-04-23
Completion
2024-04-23

Countries

  • Chile

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06465849 on ClinicalTrials.gov