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Laser Etching Effect on Application Mode of Universal Adhesive

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ClinicalTrials.gov Identifier: NCT04814836
Recruitment Status : Active, not recruiting
First Posted : March 24, 2021
Last Update Posted : March 26, 2021
Sponsor:
Information provided by (Responsible Party):
A Ruya Yazici, Hacettepe University

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Healthy Participant Procedure: Total-etch mode with 35% phosphoric acid (K-ETCHANT) (TE-A group) Procedure: Selective-etch mode with 35% phosphoric acid (K-ETCHANT) (SE-A group) Procedure: Total-etch mode with Er, Cr: YSGG laser (Waterlase MD) (TE-L group) Procedure: Selective-etch mode with Er, Cr: YSGG laser (Waterlase MD) (SE-L group). Procedure: Self-etch mode Clearfil Universal Bond Quick (Kuraray, Japan) (SE group) Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 41 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This study was carried out to investigate different etching methods used for application modes of universal adhesive on clinical performance of non-carious cervical lesions. The 35% phosphoric acid (K-ETCHANT) or Er,Cr:YSGG laser (2780 nm, Waterlase MD, BioLase Technology, Inc.) etching was applied to the tooth before these application modes in order to bond the universal adhesive, Clearfil Universal Bond Quick. Accordingly, the restorations were completed with 5 different application methods to five different teeth. The allocation of etching method and application mode on each tooth was determined in an order that was assigned by Biostatistics Department. This randomization was blinded to participants and evaluators. It was not known which etching method and application mode was applied to which teeth of the participants.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Evaluation of Cervical Composite Restorations Placed Using Universal Adhesive in Different Modes and Different Etching Methods
Actual Study Start Date : July 10, 2019
Actual Primary Completion Date : January 10, 2021
Estimated Study Completion Date : March 25, 2025
Arms and Interventions
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Arm Intervention/treatment
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.
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.
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.
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.
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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


  2. 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.


  3. 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.


  4. 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.


  5. 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.

  6. 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.



Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04814836


Locations
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Turkey
Hacettepe University Faculty of Dentistry
Ankara, Turkey, 06100
Sponsors and Collaborators
Hacettepe University
Investigators
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Principal Investigator: A. Ruya Yazici Hacettepe University Faculty of Dentistry
More Information
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Additional Information:

Publications:

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Responsible Party: A Ruya Yazici, Professor, Hacettepe University
ClinicalTrials.gov Identifier: NCT04814836    
Other Study ID Numbers: KA180076
First Posted: March 24, 2021    Key Record Dates
Last Update Posted: March 26, 2021
Last Verified: March 2021

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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
Keywords provided by A Ruya Yazici, Hacettepe University:
non-carious cervical lesions
universal adhesives
laser etching