Clinical trial NCT04807465: Different Modes of Universal Adhesive in Smokers and Non-Smokers
Official title: How Does Smoking Effect the Clinical Performance of a Universal Adhesive Used With Different Application Modes in Non Carious Cervical Lesions?
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Healthy Participant
Keywords: non-carious cervical lesions
universal adhesives
smoking
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2021-03-19
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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 outcomes:
measure: Retention
timeFrame: baseline (one week)-18-month
measure: Marginal Discoloration
timeFrame: baseline (one week)-18-month
measure: Marginal Adaptation
timeFrame: baseline (one week)-18-month
measure: Color match
timeFrame: baseline (one week)-18-month
measure: Post-op Hypersensitivity
timeFrame: baseline (one week)-18-month
measure: Secondary Caries
timeFrame: baseline (one week)-18-month
Secondary outcomes:
measure: VAS scale
timeFrame: baseline (one week)-18-month
Other outcomes:
measure: Plaque Index
timeFrame: baseline (one week)-18-month
measure: Gingival index
timeFrame: baseline (one week)-18-month
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University Faculty of Dentistry
Study officials:
affiliation: Study Principal Investigator
name: A. Ruya Yazici
role: PRINCIPAL_INVESTIGATOR
References: