Different Modes of Universal Adhesive in Smokers and Non-Smokers

Hacettepe University

Status: Active, not recruiting

Conditions: Healthy Participant

Treatments: Device: G-Premio Bond in etch&rinse mode; Device: G-Premio Bond in self-etch mode; Device: G-Premio Bond in selective-etch mode

Study type: Interventional

Funder types: Other

Identifiers

NCT04807465

interventional study

Details and patient eligibility

About

The aim of the study was to evaluate the influence of smoking on the clinical performance of a universal adhesive used with different application modes in non-carious cervical lesions.

Full description

Forty-seven patients (having at least three noncarious cervical lesions) were participated in this study. After allocation of patients into 2 groups according to their smoking habits (non-smokers; 24, smokers;23), lesions in each patient were restored with a resin composite, (Essentia, GC) using a universal adhesive G-Premio Bond and phosphoric acid (i-Dental) in three different application modes (etch&rinse, selective-etch or self-etch). The restorative treatments were performed by single operator. Two experienced and calibrated examiners evaluated the restorations for retention, marginal discoloration, marginal adaptation, color match, postoperative sensitivity and secondary caries at one week (baseline), at 6-, 12, and 18 months using modified USPHS criteria.While the USPHS criteria measure the clinical performance of the restorative material, it scores according to three different degrees;Alpha:The restoration is clinically perfect. Bravo:All features of the restoration are sufficient, need not be renewed. Charlie: the restoration is clinically unsuccessful, unacceptable. The gingival and plaque index were also assessed with a periodontal probe.

Enrollment: 47 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Patients were 18 years of age or older,
• good general health,
• acceptable oral hygiene level,
• no possible health problems (such as allergies) related to resin-based restorations,
• at least three non-carious cervical lesions with at least 20 teeth in the occlusion.
• The depth of the lesions should be at least 1 mm, without carious, not previously restored, having teeth with vital, enamel and dentin tissue.
• Patients who smoke at least 10 cigarettes per day, however patients in non-smokers have never smoked before.

Exclusion criteria

• Participant had fewer than 20 teeth,
• having poor oral hygiene,
• uncontrolled periodontal disease,
• xerostomia,
• diagnosis of bruxism,
• pregnancy or breastfeeding possible health problems (such as allergy) related to resin-based restorations
• having severe systemic disease,
• having bleaching treatment or orthodontic treatment.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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47 participants in 2 patient groups

G-Premio universal adhesive used in smoker participants

Other group

Description:

Participants who smoke at least 10 cigarettes per day

Treatment:

Device: G-Premio Bond in self-etch mode

Device: G-Premio Bond in etch&rinse mode

Device: G-Premio Bond in selective-etch mode

G-Premio universal adhesive used in non-smoker participants

Other group

Description:

participants who non-smoke have never smoked before

Treatment:

Device: G-Premio Bond in self-etch mode

Device: G-Premio Bond in etch&rinse mode

Device: G-Premio Bond in selective-etch mode