Different Modes of Universal Adhesive in Smokers and Non-Smokers

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Healthy Participant
• Intervention / Treatment: Device: G-Premio Bond in etch&rinse mode; Device: G-Premio Bond in selective-etch mode; Device: G-Premio Bond in self-etch mode

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.

• Study Type: Interventional
• Enrollment (Actual): 47
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Ankara, Turkey, 06100
    • Hacettepe University Faculty of Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plaque Index	When evaluating Plaque Index scores, only the amount of plaque in the gingival area of the tooth surfaces is taken into account. Plaque amount is evaluated with periodontal probe and scored. Plaque Index Scores 0 When examined with a periodontal probe at the edge of the gum, no plaque accumulation is seen.; When examined with a periodontal probe, it is seen that there is plaque accumulation.; Visible plaque accumulation at the edge of the gum but not completely filled in the interdental area.; An easily visible plaque accumulation on the gum edge and towards the coronal, completely filling the interdental zone	baseline (one week)-18-month
Gingival index	The periodontal probe is used to evaluate whether there is inflammation, discoloration, and gingival bleeding along the gingival sulcus. Gingival Index Scores 0 Healthy gums.; Mild inflammation: Slight discoloration and mild edema, but no bleeding on probing.; Moderate inflammation: The gingiva is shiny, there is slight redness, edema and bleeding on the gum when touched with the sond.; Severe inflammation: There is marked redness, edema and ulceration of the gums, the gum tends to bleed spontaneously.	baseline (one week)-18-month

Collaborators and Investigators

• Sponsor: Hacettepe University
• Investigators: Principal Investigator: A. Ruya Yazici, Study Principal Investigator

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2018
• Primary Completion (Actual): March 1, 2021
• Study Completion (Anticipated): January 1, 2025

Study Registration Dates

• First Submitted: March 13, 2021
• First Submitted That Met QC Criteria: March 18, 2021
• First Posted (Actual): March 19, 2021

Study Record Updates

• Last Update Posted (Actual): March 23, 2021
• Last Update Submitted That Met QC Criteria: March 19, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: smoking; non-carious cervical lesions; universal adhesives
• Other Study ID Numbers: interventional study

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No