NCT04756349

Clinical Performance of Adhesive Systems Containing HEMA and 10-MDP in Non Carious Cervical Lesions

Clinical Performance of Adhesive Systems Containing HEMA and 10-MDP in Non Carious Cervical Lesions - A Two Years Randomized Double Blind Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Universidade Federal do Para · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The objective of this randomized, double-blind clinical trial is to evaluate the clinical performance of non-carious cervicals adhesive restorations using three self-etching adhesives containing HEMA and 10-MDP monomers.

Detailed description

Sixty teeth (n = 20 for each group) will be randomized into 03 groups: Clearfil SE (contains MDP and HEMA), Optibond All-inOne (contains HEMA) and Prime and Bond Universal (contains neither monomer) dispatch). Restorations will be performed by a single operator, and no mechanical retention will be performed under the cavity. After 6, 12 and 24 months, the restorations will be evaluated by two calibrated examiners, using modified USPHS criteria for retention (kappa = 1.00) and adaptation / marginal color (kappa = 0.81), and the results will be analysed by Fisher and Kruskal-Wallis, respectively. An intragroup analysis will be performed using the Cochran test (for retention) and Wilcoxon (for marginal adaptation / staining).

Conditions

• Non Carious Cervical Lesion

Interventions

Type	Name	Description
OTHER	composite resin restoration	All patients will receive adhesive composite resin restorations. There will be 3 groups (different adhesives): Clearfil SE, Optibond All-in-One and Prime \& Bond Universal.

Timeline

• Start date: 2020-02-12
• Primary completion: 2021-02-12
• Completion: 2022-02-12
• First posted: 2021-02-16
• Last updated: 2022-05-24

Locations

1 site across 1 country: Brazil