NCT04814836|Unknown
Laser Etching Effect on Application Mode of Universal Adhesive
Clinical Evaluation of Cervical Composite Restorations Placed Using Universal Adhesive in Different Modes and Different Etching Methods
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Clinical Evaluation of Cervical Composite Restorations Placed Using Universal Adhesive in Different Modes and Different Etching Methods
Sponsor study identifier
interventional
41
1 country
1
Study Start
July 10, 2019
Actual (reported)Primary Completion
January 10, 2021
Actual (reported)Study Completion
March 25, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 25, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 10, 2019
Actual (reported)January 10, 2021
Actual (reported)March 11, 2021
Actual (reported)March 24, 2021
Actual (reported)March 25, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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
Total-etch mode with 35% phosphoric acid
Selective-etch mode with 35% phosphoric acid
Total-etch mode with laser (Er,Cr:YSGG)
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.
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.
Hacettepe University Faculty of Dentistry
Ankara, 06100, Turkey (Türkiye)
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.
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.
A. Ruya Yazici
Hacettepe University
41 participants (actual enrollment reported by the registry).
First Submitted
March 11, 2021
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
Selective-etch mode with laser (Er,Cr:YSGG)
Self-etch mode
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.
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.
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.
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First Posted
March 24, 2021
Study Start
July 10, 2019
Actual (reported)Primary Completion
January 10, 2021
Actual (reported)Study Completion
March 25, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
March 26, 2021
Record last verified: 2021-03
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