Different Modes of Universal Adhesive in Smokers and Non-Smokers

Not Applicable

Active, not recruiting

• Conditions: Healthy Participant
• Interventions: Device: G-Premio Bond in etch&rinse mode; Device: G-Premio Bond in selective-etch mode; Device: G-Premio Bond in self-etch mode

• Registration Number: NCT04807465
• Lead Sponsor: Hacettepe University

Brief 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.

Detailed 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2018-09-01
• Status Verified: 2021-03
• Primary Completion: 2021-03-01
• Study First Submitted: 2021-03-13
• Study First Submitted QC: 2021-03-18
• Study First Posted: 2021-03-19
• Last Update Submitted: 2021-03-19
• Last Update Posted: 2021-03-23
• Study Completion: 2025-01-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 47

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
G-Premio universal adhesive used in smoker participants	G-Premio Bond in etch&rinse mode	Participants who smoke at least 10 cigarettes per day
G-Premio universal adhesive used in smoker participants	G-Premio Bond in self-etch mode	Participants who smoke at least 10 cigarettes per day
G-Premio universal adhesive used in non-smoker participants	G-Premio Bond in selective-etch mode	participants who non-smoke have never smoked before
G-Premio universal adhesive used in non-smoker participants	G-Premio Bond in self-etch mode	participants who non-smoke have never smoked before
G-Premio universal adhesive used in smoker participants	G-Premio Bond in selective-etch mode	Participants who smoke at least 10 cigarettes per day
G-Premio universal adhesive used in non-smoker participants	G-Premio Bond in etch&rinse mode	participants who non-smoke have never smoked before

Primary Outcome Measures

Name	Time	Method
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.
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.
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.

Secondary Outcome Measures

Name	Time	Method
VAS scale	baseline (one week)-18-month	Sensitivity to air was assessed by appling a stream of compressed air for three second 1 cm away from the tooth surface while shielding the neighboring teeth with the fingers. After this application, individuals are asked to evaluate the sensitivity of the tooth according to the Visual Analog Scale (VAS). VAS consists of a straight line 10 centimeters (cm) long. The left end of the line is 0 and it means "no pain, the right end is 10", meaning unbearable pain. With the help of this scale, the pain levels in the teeth of individuals with hypersensitivity can be determined.

Trial Locations

Locations (1)

Hacettepe University Faculty of Dentistry; 🇹🇷 Ankara, Turkey