Different Modes of Universal Adhesive in Smokers and Non-Smokers

NCT04807465 · tracked via the Priya Life Science Turkey tracker

Sponsor

Hacettepe University

Phase

Not applicable

Started

2018-09-01

Last updated

2026-06-26

Condition(s) studied

Healthy Participant

Investigational drug(s) / intervention(s)

G-Premio Bond in etch&rinse modeG-Premio Bond in selective-etch modeG-Premio Bond in self-etch mode

G-Premio Bond in etch&rinse mode: The phosphoric acid gel was applied to enamel and dentin washed for 5s and was dried gently with air spray. The adhesive system was applied to enamel and dentin surfaces and leave it in place for 10s.

G-Premio Bond in selective-etch mode: The phosphoric acid was applied only on enamel for 10-15s then washed and was gently dried with air spray. The adhesive system was applied to enamel and dentin surfaces.

G-Premio Bond in self-etch mode: The adhesive system was applied to the enamel and dentin surfaces.

Study summary

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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

75 Years

Healthy volunteers

Accepted

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.

Primary outcome measure(s)

Retention — baseline (one week)-18-month
According to the usphs criteria, retention indicates whether a restorative material is functional in the oral environment, and is the most important criterion by which we can evaluate the success of the material. Alpha: Retained. Charlie: Mobile or missing; clinically unacceptable.
Marginal Discoloration — baseline (one week)-18-month
Evaluation of color changes in restoration margins and linear staining along restoration margins. Alfa: No discoloration along the margin. Bravo: Slight and superficial staining (removable, usually localized). Charlie: Deep staining cannot be polished away.
Marginal Adaptation — baseline (one week)-18-month
The marginal adaptation criterion evaluates the complete achievement of tooth-restoration integrity. Alpha: Undetectable. Bravo: Visible evidence of a crevice along the margin, dentin not exposed, clinically acceptable. Charlie: Explorer penetrates into crevice, dentin is exposed; clinically unacceptable.
Color match — baseline (one week)-18-month
Evaluating whether the restoration and adjacent tooth tissue color is compatible. Alpha:Matches tooth. Bravo: Acceptable mismatch. Charlie:Unacceptable mismatch.
Post-op Hypersensitivity — baseline (one week)-18-month
It is the evaluation of sensitivity after dental treatment. Alpha: Hypersensitivity absent. Charlie: Present; clinically unacceptable.
Secondary Caries — baseline (one week)-18-month
In this criterion, the dark colored area that occurs under the tooth tissue surface and in the tooth tissue adjacent to the restoration is defined as caries. Alpha: Caries absent. Charlie: Present; clinically unacceptable.

Trial sites (1)

Facility	City	Region	Status
Hacettepe University Faculty of Dentistry	Ankara	Turkey (Türkiye)

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04807465 on ClinicalTrials.gov ↗ ← All trials in Turkey