Laser Etching Effect on Application Mode of Universal Adhesive

NCT ID: NCT04814836

Last Updated: 2021-03-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-10

Study Completion Date

2025-03-25

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Healthy Participant

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group I

Total-etch mode with 35% phosphoric acid

Group Type OTHER

Total-etch mode with 35% phosphoric acid (K-ETCHANT) (TE-A group)

Intervention Type PROCEDURE

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

Group Type OTHER

Selective-etch mode with 35% phosphoric acid (K-ETCHANT) (SE-A group)

Intervention Type PROCEDURE

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)

Group Type OTHER

Total-etch mode with Er, Cr: YSGG laser (Waterlase MD) (TE-L group)

Intervention Type PROCEDURE

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)

Group Type OTHER

Selective-etch mode with Er, Cr: YSGG laser (Waterlase MD) (SE-L group).

Intervention Type PROCEDURE

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

Group Type OTHER

Self-etch mode Clearfil Universal Bond Quick (Kuraray, Japan) (SE group)

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type 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.

Intervention Type 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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hacettepe University

OTHER

Sponsor Role lead

Responsible Party

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A Ruya Yazici

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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A. Ruya Yazici

Role: PRINCIPAL_INVESTIGATOR

Hacettepe University

Locations

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Hacettepe University Faculty of Dentistry

Ankara, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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Atalay C, Uslu A, Yazici AR. Does laser etching have an effect on application mode of a universal adhesive?-A microleakage and scanning electron microscopy evaluation. Microsc Res Tech. 2021 Jan;84(1):125-132. doi: 10.1002/jemt.23573. Epub 2020 Aug 27.

Reference Type BACKGROUND
PMID: 32852126 (View on PubMed)

Atalay C, Ozgunaltay G, Yazici AR. Thirty-six-month clinical evaluation of different adhesive strategies of a universal adhesive. Clin Oral Investig. 2020 Apr;24(4):1569-1578. doi: 10.1007/s00784-019-03052-2. Epub 2019 Aug 30.

Reference Type BACKGROUND
PMID: 31468262 (View on PubMed)

Related Links

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Other Identifiers

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KA180076

Identifier Type: -

Identifier Source: org_study_id

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