36-Month Clinical Evaluation of a Universal Adhesive

Not Applicable

Completed

• Conditions: Non-Carious Cervical Lesions
• Interventions: Device: Scotchbond Universal Adhesive (3M ESPE)

• Registration Number: NCT03932929
• Lead Sponsor: Hacettepe University

Brief Summary

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.

Detailed Description

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 Timeline

• Study Start: 2015-09-02
• Primary Completion: 2018-09-02
• Study Completion: 2018-09-02
• Study First Submitted: 2019-04-17
• Study First Submitted QC: 2019-04-26
• Status Verified: 2019-05
• Study First Posted: 2019-05-01
• Last Update Submitted: 2019-05-02
• Last Update Posted: 2019-05-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Scotchbond universal adhesive (self-etch)	Scotchbond Universal Adhesive (3M ESPE)	Adhesive agent Intervention: Device: Adhesive agent
Scotchbond universal adhesive (etch-and-rinse)	Scotchbond Universal Adhesive (3M ESPE)	Acid etch (enamel\&dentin)+adhesive agent Intervention: Device: Adhesive agent
Scotchbond universal adhesive (selective-etch)	Scotchbond Universal Adhesive (3M ESPE)	Acid etch (only enamel)+adhesive agent Intervention: Device: Adhesive agent

Primary Outcome Measures

Name	Time	Method
Marginal adaptation	From baseline to 36 month	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
Postoperative sensitivity	From baseline to 36 month	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
Marginal staining	From baseline to 36 month	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
Retention	From baseline to 36 month	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
Seconder caries	From baseline to 36 month	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 caries present. Charlie: Caries present

Trial Locations

Locations (1)

Hacettepe University; 🇹🇷 Ankara, Turkey