Laser Etching Effect on Application Mode of Universal Adhesive

Not Applicable

Active, not recruiting

• Conditions: Healthy Participant
• Interventions: Procedure: Selective-etch mode with 35% phosphoric acid (K-ETCHANT) (SE-A group); Procedure: Total-etch mode with 35% phosphoric acid (K-ETCHANT) (TE-A group); Procedure: Self-etch mode Clearfil Universal Bond Quick (Kuraray, Japan) (SE group)

• Registration Number: NCT04814836
• Lead Sponsor: Hacettepe University

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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2019-07-10
• Primary Completion: 2021-01-10
• Status Verified: 2021-03
• Study First Submitted: 2021-03-11
• Study First Submitted QC: 2021-03-23
• Study First Posted: 2021-03-24
• Last Update Submitted: 2021-03-25
• Last Update Posted: 2021-03-26
• Study Completion: 2025-03-25

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 41

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.

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group II	Selective-etch mode with 35% phosphoric acid (K-ETCHANT) (SE-A group)	Selective-etch mode with 35% phosphoric acid
Group I	Total-etch mode with 35% phosphoric acid (K-ETCHANT) (TE-A group)	Total-etch mode with 35% phosphoric acid
Group V	Self-etch mode Clearfil Universal Bond Quick (Kuraray, Japan) (SE group)	Self-etch mode

Primary Outcome Measures

Name	Time	Method
Retention,	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.
Marginal Adaptation	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.
Marginal Discoloration	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.
Color match	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.
Post-op Hypersensitivity	From baseline to 2 year the change of restorations was evaluated	Determination of sensitivity after restorations are placed. Alpha: Absent. Charlie: Present; clinically unacceptable.
Secondary Caries	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.

Trial Locations

Locations (1)

Hacettepe University Faculty of Dentistry; 🇹🇷 Ankara, Turkey