Laser Etching Effect on Application Mode of Universal Adhesive

Healthy Participant Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04814836
• Other study ID #: KA180076
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 10, 2019
• Est. completion date: March 25, 2025

Study information

• Verified date: March 2021
• Source: Hacettepe University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 41
• Est. completion date: March 25, 2025
• Est. primary completion date: January 10, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Participant

Intervention

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.
• 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.
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
Turkey	Hacettepe University Faculty of Dentistry	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Hacettepe University

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

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

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