Clinical trial NCT04814836: Laser Etching Effect on Application Mode of Universal Adhesive
Official title: Clinical Evaluation of Cervical Composite Restorations Placed Using Universal Adhesive in Different Modes and Different Etching Methods
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Healthy Participant
Keywords: non-carious cervical lesions
universal adhesives
laser etching
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2021-03-24
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Retention,
timeFrame: From baseline to 2 year the change of restorations was evaluated
measure: Marginal Discoloration
timeFrame: From baseline to 2 year the change of restorations was evaluated
measure: Marginal Adaptation
timeFrame: From baseline to 2 year the change of restorations was evaluated
measure: Color match
timeFrame: From baseline to 2 year the change of restorations was evaluated
measure: Post-op Hypersensitivity
timeFrame: From baseline to 2 year the change of restorations was evaluated
measure: Secondary Caries
timeFrame: From baseline to 2 year the change of restorations was evaluated
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University Faculty of Dentistry
Study officials:
affiliation: Hacettepe University Faculty of Dentistry
name: A. Ruya Yazici
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.