Laser Etching Effect on Application Mode of Universal Adhesive

March 25, 2021 updated by: A Ruya Yazici, Hacettepe University

Clinical Evaluation of Cervical Composite Restorations Placed Using Universal Adhesive in Different Modes and Different Etching Methods

To evaluate the clinical performance of the restorations by applying the universal adhesive in different modes under the influence of different surface treatments, with Erbium Chromium:Yttrium-Scandium-Gallium-Garnet (Er,Cr:YSGG) laser and acid etching in non-carious cervical lesions.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Forty-one patients (at least five non-carious cervical lesions) have participated in this study. The non-carious cervical lesions in each patient were divided into five groups (total-etch mode with phosphoric acid, selective-etch mode with phosphoric acid, total-etch mode with laser, selective-etch mode with laser and self-etch mode) according to different modes and application methods of universal adhesive (Clearfil Universal Bond Quick, Kuraray). Lesions were restored with a resin composite, Clearfil Majesty ES-2 (Kuraray). All restorative procedures were performed by a single operator. Restorations were evaluated at one week (baseline), at 6-, 12-, 18- and 24-month according to modified USPHS criteria (retention, marginal discoloration, marginal adaptation, color match, postoperative sensitivity, and secondary caries) by two experienced and calibrated investigators.

Study Type

Interventional

Enrollment (Actual)

41

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

  • Turkey
      • Ankara, Turkey, 06100
        • Hacettepe University Faculty of Dentistry

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

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Participants were 18 years of age or older,
  • no possible health problems (such as allergies) related to resin-based restorations,
  • good general health,
  • having at least five non-carious cervical lesions.
  • The depth of the lesions were at least 1 mm, without carious, not previously restored, having teeth with vital, enamel and dentin tissue.

Exclusion Criteria

  • Participant had fewer than 20 teeth,
  • having poor oral hygiene,
  • uncontrolled periodontal disease,
  • xerostomia,
  • pregnancy or breastfeeding possible health problems (such as allergy) related to resin-based restorations,
  • having bleaching treatment or orthodontic treatment.

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Group I
Total-etch mode with 35% phosphoric acid
Procedure: Total-etch mode with 35% phosphoric acid (K-ETCHANT) (TE-A group)
35% phosphoric acid was applied to enamel and dentin for 10 s, washed and dried for 5 s. The universal adhesive, Clearfil Universal Bond Quick (CBQ) was applied to enamel and dentin surfaces with a single-use applicator, then gently air-dried for 5 s without waiting, and light-cured for 10 s.
Other: Group II
Selective-etch mode with 35% phosphoric acid
Procedure: Selective-etch mode with 35% phosphoric acid (K-ETCHANT) (SE-A group)
35% phosphoric acid was used only on enamel for 10 s, then washed and dried for 5 seconds. Subsequently, the adhesive was applied in a similar manner to the TE-A group.
Other: Group III
Total-etch mode with laser (Er,Cr:YSGG)
Procedure: Total-etch mode with Er, Cr: YSGG laser (Waterlase MD) (TE-L group)
the enamel margin and dentin surfaces of lesions were irradiated with an Er,Cr:YSGG laser (2780 nm, Waterlase MD, BioLase Technology, Inc., San Clemente, CA). Then the adhesive was applied in a similar manner to the TE-A group.
Other: Group IV
Selective-etch mode with laser (Er,Cr:YSGG)
Procedure: Selective-etch mode with Er, Cr: YSGG laser (Waterlase MD) (SE-L group).
The laser system was applied in the same way as described in the TE-L group only on enamel surface. Subsequently, the adhesive was applied in the same way as described in the TE-A group.
Other: Group V
Self-etch mode
Procedure: Self-etch mode Clearfil Universal Bond Quick (Kuraray, Japan) (SE group)
Universal adhesive system (CBQ) was applied to enamel and dentin surfaces without any previous etching. Then gently air-dried for 5 s without waiting, and light-cured for 10 s.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Retention,
Time Frame: From baseline to 2 year the change of restorations was evaluated

The retention criterion determines how long a restorative material functions in the oral environment, it is the most important criterion that shows the success of the material.

Alpha: The restoration is present. Charlie: The restoration is absent.
From baseline to 2 year the change of restorations was evaluated
Marginal Discoloration
Time Frame: From baseline to 2 year the change of restorations was evaluated

The marginal discoloration that occur at the edge staining restoration boundaries are generally thought to be due to microleakage.

Alpha: No discoloration at margins. Bravo: Shallow discoloration, clinically acceptable. Charlie: Deep discoloration clinically unacceptable.
From baseline to 2 year the change of restorations was evaluated
Marginal Adaptation
Time Frame: From baseline to 2 year the change of restorations was evaluated

Marginal adaptation is achieved by fully ensuring the integrity of the tooth-restoration joint border.

Alpha: Restoration is closely adapted to the tooth. Bravo: Visible evidence of a crevice along the margin, dentin not exposed, clinically acceptable.

Charlie: Explorer penetrates into crevice, dentin is exposed; clinically unacceptable.
From baseline to 2 year the change of restorations was evaluated
Color match
Time Frame: From baseline to 2 year the change of restorations was evaluated

Color match is the evaluation of the restoration according to the darkening or lightening of the color, taking into account the tooth tissue surrounding restoration.

Alpha:Matches tooth. Bravo: Acceptable mismatch. Charlie:Unacceptable mismatch.
From baseline to 2 year the change of restorations was evaluated
Post-op Hypersensitivity
Time Frame: From baseline to 2 year the change of restorations was evaluated
Determination of sensitivity after restorations are placed. Alpha: Absent. Charlie: Present; clinically unacceptable.
From baseline to 2 year the change of restorations was evaluated
Secondary Caries
Time Frame: From baseline to 2 year the change of restorations was evaluated

Secondary caries is the progression of caries in the tooth tissue adjacent to the restorations. Caries formation means restoration failure.

Alpha: Absent. Charlie: Present; clinically unacceptable.
From baseline to 2 year the change of restorations was evaluated

Collaborators and Investigators

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

Sponsor

Hacettepe University

Investigators

  • Principal Investigator: A. Ruya Yazici, Hacettepe University Faculty of Dentistry

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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)

July 10, 2019

Primary Completion (Actual)

January 10, 2021

Study Completion (Anticipated)

March 25, 2025

Study Registration Dates

First Submitted

March 11, 2021

First Submitted That Met QC Criteria

March 23, 2021

First Posted (Actual)

March 24, 2021

Study Record Updates

Last Update Posted (Actual)

March 26, 2021

Last Update Submitted That Met QC Criteria

March 25, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • KA180076

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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