Evaluation of Double Layer Application Using a Universal Adhesive in the Quality of Cervical Lesions Restorations

June 24, 2024 updated by: Mario Felipe Gutiérrez Reyes, Universidad de los Andes, Chile

Clinical Evaluation of the Effect of Double Layer Application Using a Universal Adhesive in Restorations of Non-carious Cervical Lesions: Double-blind Randomized Clinical Trial

The aim of this study will be to evaluate the effect of a double layer application of a universal adhesive system used as etch-and-rinse application mode in non-carious cervical lesions (NCCLs), on the 6- and 12-months clinical performance.

Materials & Methods: 144 restorations were randomly placed in 36 subjects (16 male and 20 female) according to the following groups (n=36): ER1 (one layer of Scotchbond Universal Plus adhesive applied as etch-and-rinse mode); ER2 (double layer of Scotchbond Universal Plus adhesive applied as etch-and-rinse mode); SEE1 (one layer of Scotchbond Universal Plus adhesive applied as selective enamel etching); SEE2 (double layer of Scotchbond Universal Plus adhesive applied as selective enamel etching). All groups were light-cured for 10s/1,000 mW/cm2 only after final layer. 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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a four-arm, double-blind, randomized controlled clinical trial. Experimental group 1: 35 non-carious cervical lesions (NCCL) will receive composite resin restorations applying a double layer of Scotchbond Universal Plus adhesive applied as etch-and-rinse mode.

Experimental group 2: 35 non-carious cervical lesions (NCCL) will receive composite resin restorations applying a double layer of Scotchbond Universal Plus adhesive applied as selective enamel etching mode.

Control group 1: 35 non-carious cervical lesions (NCCL) will receive composite resin restorations applying one layer of Scotchbond Universal Plus adhesive applied as etch-and-rinse mode.

Control group 2: 35 non-carious cervical lesions (NCCL) will receive composite resin restorations applying one layer of Scotchbond Universal Plus adhesive applied as selective enamel etching mode.

LCNCs will be randomized to application mode and number of layers. All groups will be light-cured with a light-curing device (SmartLite Focus, Dentsply) with a light intensity of 900 mW/cm² for 10 seconds. Operators will restore the cervical area by applying three increments of resin (Filtek Supreme XT, 3M). Each increment will light cure for 20 s at 900 mW/cm2 (SmartLite Focus, Dentsply). Restorations will be finished immediately with fine and extra fine diamond burs and polished with polishing spirals.

Study Type

Interventional

Enrollment (Actual)

35

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Chile
    • Región Metropolitana
      • Santiago, Región Metropolitana, Chile, 8360053
        • Mario Felipe Gutiérrez Reyes

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Patients older than 18 years.
  • Presence of at least two Non-Carious Cervical Lesions in the dental arch with a need for restorative treatment.
  • Acceptable level of oral hygiene according to the Simplified Oral Hygiene Index.
  • At least 20 teeth in function.
  • Non-Carious Cervical Lesions with a maximum of 50% of enamel margin.

Exclusion Criteria:

  • Driving difficulties that prevent adequate oral hygiene.
  • Periodontal disease.
  • Active caries lesions on the teeth included in the research.
  • Parafunctional habits.
  • Active staples of removable partial dentures on the teeth included in the research and that these are not pillars of prostheses.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental: Experimental group 1
35 non-carious cervical lesions (NCCL) will receive composite resin restorations applying double layer of Scotchbond Universal Plus adhesive applied as etch-and-rinse mode
Procedure: Application of double layer
35 non-carious cervical lesions (NCCL) will receive composite resin restorations applying double layer of Scotchbond Universal Plus adhesive
Procedure: Etch-and-rinse application mode
35 non-carious cervical lesions (NCCL) will receive composite resin restorations applying Scotchbond Universal Plus adhesive applied as etch-and-rinse application mode
Experimental: Experimental group 2
35 non-carious cervical lesions (NCCL) will receive composite resin restorations applying double layer of Scotchbond Universal Plus adhesive applied as selective enamel etching mode
Procedure: Application of double layer
35 non-carious cervical lesions (NCCL) will receive composite resin restorations applying double layer of Scotchbond Universal Plus adhesive
Procedure: Selective enamel etching application mode
35 non-carious cervical lesions (NCCL) will receive composite resin restorations applying Scotchbond Universal Plus adhesive applied as selective enamel etching mode
Active Comparator: Control group 1
35 non-carious cervical lesions (NCCL) will receive composite resin restorations applying one layer of Scotchbond Universal Plus adhesive applied as etch-and-rinse mode
Procedure: Etch-and-rinse application mode
35 non-carious cervical lesions (NCCL) will receive composite resin restorations applying Scotchbond Universal Plus adhesive applied as etch-and-rinse application mode
Procedure: Application of one layer
35 non-carious cervical lesions (NCCL) will receive composite resin restorations applying one layer of Scotchbond Universal Plus adhesive
Active Comparator: Control group 2
35 non-carious cervical lesions (NCCL) will receive composite resin restorations applying one layer of Scotchbond Universal Plus adhesive applied as selective enamel etching mode
Procedure: Selective enamel etching application mode
35 non-carious cervical lesions (NCCL) will receive composite resin restorations applying Scotchbond Universal Plus adhesive applied as selective enamel etching mode
Procedure: Application of one layer
35 non-carious cervical lesions (NCCL) will receive composite resin restorations applying one layer of Scotchbond Universal Plus adhesive

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Retention rate of restorations
Time Frame: From date of randomization until twenty four months

Retention rate measured by World Dental Federation (FDI) criteria as following:

  • G: Clinically good - Small hairline crack;
  • SS: Clinically sufficient/satisfactory - Two or more or larger hairline cracks and/or chipping (not affecting the marginal integrity);
  • US: Clinically unsatisfactory - Chipping fractures which damage marginal quality; bulk fractures with or without partial loss (less than half of the restoration);
  • PO: Clinically poor - (Partial or complete) loss of restoration, (replacement necessary).
From date of randomization until twenty four months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Marginal Adaptation rate of restorations
Time Frame: From date of randomization until twenty four months

Marginal Adaptation rate measured by World Dental Federation (FDI) criteria as following:

  • VG: Clinically very good - Harmonious outline, no gaps, no discoloration;
  • G: Clinically good - Small marginal fracture removable by polishing;
  • SS: Clinically sufficient/satisfactory - Several small enamel or dentin fractures;
  • US: Clinically unsatisfactory - Notable enamel or dentine wall fracture;
  • PO: Clinically poor - Filling is loose but in situ.
From date of randomization until twenty four months
Marginal Staining rate of restorations
Time Frame: From date of randomization until twenty four months]

Marginal Staining rate measured by World Dental Federation (FDI) criteria as following:

  • VG: Clinically very good - No marginal staining;
  • G: Clinically good - Minor marginal staining, easily removable by polishing;
  • SS: Clinically sufficient/satisfactory - Moderate marginal staining, not esthetically unacceptable;
  • US: Clinically unsatisfactory - Pronounced marginal staining; major intervention necessary for improvement;
  • PO: Clinically poor - Deep marginal staining not accessible for intervention
From date of randomization until twenty four months]

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad de los Andes, Chile

Collaborators

Agencia Nacional de Investigación y Desarrollo

Investigators

  • Study Director: Mario Felipe Gutierrez Reyes, Universidad de los Andes, Chile

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2024

Primary Completion (Actual)

March 1, 2024

Study Completion (Actual)

March 1, 2024

Study Registration Dates

First Submitted

June 19, 2024

First Submitted That Met QC Criteria

June 19, 2024

First Posted (Actual)

June 25, 2024

Study Record Updates

Last Update Posted (Actual)

June 26, 2024

Last Update Submitted That Met QC Criteria

June 24, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CEC2024050

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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