Laser Etching Effect on Application Mode of Universal Adhesive

NCT04814836 | Unknown

• 1 other identifier: KA180076
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Participant

Keywords

non-carious cervical lesions; universal adhesives; laser etching

Outcome Measures

Primary Outcomes (6)

• 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

• 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

• 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

• 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

• 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

• 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

Study Arms (5)

Group I

OTHER

Total-etch mode with 35% phosphoric acid

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

Group II

OTHER

Selective-etch mode with 35% phosphoric acid

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

Group III

OTHER

Total-etch mode with laser (Er,Cr:YSGG)

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

Group IV

OTHER

Selective-etch mode with laser (Er,Cr:YSGG)

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

Group V

OTHER

Self-etch mode

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

Interventions

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

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

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

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

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

Group V

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Hacettepe University Faculty of Dentistry

Ankara, 06100, Turkey (Türkiye)

Location

Related Publications (2)

• 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.

  PMID: 32852126 BACKGROUND

• 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.

  PMID: 31468262 BACKGROUND

Related Links

• Related Info

MeSH Terms

Interventions

phosphoric acid

Study Officials

• A. Ruya Yazici

  Hacettepe University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: March 11, 2021
• First Posted: March 24, 2021
• Study Start: July 10, 2019
• Primary Completion: January 10, 2021
• Study Completion: March 25, 2025
• Last Updated: March 26, 2021

Record last verified: 2021-03

Locations

TU (1)