Different Modes of Universal Adhesive in Smokers and Non-Smokers

Study Overview
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Brief Summary
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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
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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.

Official Title
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How Does Smoking Effect the Clinical Performance of a Universal Adhesive Used With Different Application Modes in Non Carious Cervical Lesions?

Conditions
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Healthy Participant

Intervention / Treatment
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* Device: G-Premio Bond in etch&rinse mode
* Device: G-Premio Bond in selective-etch mode
* Device: G-Premio Bond in self-etch mode


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 47 participants having at least three non-carious cervical lesions were included in the study. Participants were divided into two groups as smokers and non-smokers. Before treatment, the dimensions and depth of the lesions were measured with periodontal probe and the sensitivity of each tooth was determined using VAS scale. All of the non-carious cervical lesions were restored with a resin composite, Essentia,GC using one of three different application modes of universal adhesive, G-Premio Bond (etch&rinse, selective-etch, self-etch). The restorations were placed by a single operator. Two calibrated examiners who were fully blind to restorative procedure evaluated the restorations in terms of retention, marginal discoloration, marginal adaptation, color match, postoperative sensitivity and secondary caries using modified USPHS criteria. The plaque and gingival index were also asessed at baseline and every 6 months of clinical service for 18 months.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: G-Premio universal adhesive used in smoker participants<br>Participants who smoke at least 10 cigarettes per day | Device: G-Premio Bond in etch&rinse mode<br>* 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.<br>Device: G-Premio Bond in selective-etch mode<br>* 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.<br>Device: G-Premio Bond in self-etch mode<br>* The adhesive system was applied to the enamel and dentin surfaces.<br>|
| Other: G-Premio universal adhesive used in non-smoker participants<br>participants who non-smoke have never smoked before | Device: G-Premio Bond in etch&rinse mode<br>* 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.<br>Device: G-Premio Bond in selective-etch mode<br>* 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.<br>Device: G-Premio Bond in self-etch mode<br>* The adhesive system was applied to the enamel and dentin surfaces.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Retention | 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. | baseline (one week)-18-month | 
| Marginal Discoloration | 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. | baseline (one week)-18-month | 
| Marginal Adaptation | 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. | baseline (one week)-18-month | 
| Color match | Evaluating whether the restoration and adjacent tooth tissue color is compatible. Alpha:Matches tooth. Bravo: Acceptable mismatch. Charlie:Unacceptable mismatch. | baseline (one week)-18-month | 
| Post-op Hypersensitivity | It is the evaluation of sensitivity after dental treatment. Alpha: Hypersensitivity absent. Charlie: Present; clinically unacceptable. | baseline (one week)-18-month | 
| Secondary Caries | 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. | baseline (one week)-18-month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VAS scale | 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. | baseline (one week)-18-month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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non-carious cervical lesions, universal adhesives, smoking