36-Month Clinical Evaluation of a Universal Adhesive

Hacettepe University35 enrolled

Overview

The aim of this clinical trial was to evaluate and compare the performance of a universal adhesive with different adhesive strategies in the restoration of non-carious cervical lesions (NCCLs) over a 36-month period.

One hundred sixty-five NCCLs in 35 patients (13 female, 22 male) with at least 3 lesions were included in this study. Three groups were formed according to adhesive strategies used (n=55): selective-etch mode; etch-and-rinse mode (ER); or self-etch (SE) mode of a universal adhesive, Single Bond Universal. The same nanofilled resin composite, Filtek Ultimate was used for all restorations by a single operator. The restorations were evaluated by two calibrated examiners at baseline and at 6-, 12-, 18-, 24- and 36- months in accordance with the modified USPHS criteria. The Chi-square test was used for intergroup, the Cochran Q test was used for intragroup comparison.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

SINGLE

Enrollment

Conditions

Non-Carious Cervical Lesions

Interventions

Scotchbond Universal Adhesive (3M ESPE)DEVICE

Adhesive system

Eligibility

Sex: ALLMin age: 18 YearsMax age: 81 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * over 18 years old * good oral hygiene * available for recall * at least 20 teeth under occlusion * the presence of at least three non-carious cervical lesions Exclusion Criteria: * poor oral hygiene * bruxism habits * severe or chronic periodontitis * If the teeth selected for study, were nonvital, or had any restorations on other surfaces were not included.

Locations (1)

Hacettepe University

Ankara, Turkey (Türkiye)

Outcomes

Primary Outcomes

Marginal adaptation

Observers evaluated the restorations was performed using the modified United State Public Health Service criteria regarding marginal adaptation. Marginal adaptation was evaluated by 2 independent clinicians. Visual inspection with a mirror was performed . Scores; Alfa: Closely adapted, no visible crevice. Bravo: Visible crevice, explorer will penetrate. Charlie: Crevice in which dentin is exposed

Time frame: From baseline to 36 month

Marginal staining

Observers evaluated the restorations was performed using the modified United State Public Health Service criteria regarding marginal staining. Marginal staining was evaluated by 2 independent clinicians. Visual inspection with a mirror was performed . Scores: Alfa: No discoloration. Bravo: Discoloration without. Charlie: Discoloration with penetration in pulpal direction

Time frame: From baseline to 36 month

Retention

Observers evaluated the restorations was performed using the modified United State Public Health Service criteria regarding retention rate. Retention rate was evaluated by 2 independent clinicians. Scores: Alfa: No loss of restorative material. Charlie: Any loss of restorative material

Time frame: From baseline to 36 month

Postoperative sensitivity

Observers evaluated the restorations was performed using the modified United State Public Health Service criteria regarding retention rate. Retention rate was evaluated by 2 independent clinicians. Scores: Alfa: Not present. Bravo: sensitive but diminishing in intensity. Charlie:constant sensitivity, not diminishing in intensity

Time frame: From baseline to 36 month

Seconder caries

Data from ClinicalTrials.gov

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