How Does Smoking Effect the Clinical Performance of a Universal Adhesive Used With Different Application Modes in Non Carious Cervical Lesions?
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 47
- 试验地点
- 1
- 主要终点
- Color match
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
G-Premio universal adhesive used in non-smoker participants
participants who non-smoke have never smoked before
干预措施: G-Premio Bond in self-etch mode (Device)
G-Premio universal adhesive used in smoker participants
Participants who smoke at least 10 cigarettes per day
干预措施: G-Premio Bond in etch&rinse mode (Device)
G-Premio universal adhesive used in smoker participants
Participants who smoke at least 10 cigarettes per day
干预措施: G-Premio Bond in selective-etch mode (Device)
G-Premio universal adhesive used in smoker participants
Participants who smoke at least 10 cigarettes per day
干预措施: G-Premio Bond in self-etch mode (Device)
G-Premio universal adhesive used in non-smoker participants
participants who non-smoke have never smoked before
干预措施: G-Premio Bond in etch&rinse mode (Device)
G-Premio universal adhesive used in non-smoker participants
participants who non-smoke have never smoked before
干预措施: G-Premio Bond in selective-etch mode (Device)
结局指标
主要结局
Color match
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: baseline (one week)-18-month
It is the evaluation of sensitivity after dental treatment. Alpha: Hypersensitivity absent. Charlie: Present; clinically unacceptable.
Secondary Caries
时间窗: 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.
次要结局
- VAS scale(baseline (one week)-18-month)
研究者
A Ruya Yazici
professor
Hacettepe University