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

Universidade Federal do Para

Status: Completed

Conditions: Non Carious Cervical Lesion

Treatments: Other: composite resin restoration

Study type: Interventional

Funder types: Other

Identifiers

NCT04756349

UFPara

Details and patient eligibility

About

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.

Full 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).

Enrollment: 18 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Good oral hygiene
• Absence of periodontal disease
• Presence of at least 02 non-carious cervical lesions

Exclusion criteria

• Presence of non-carious cervical lesion in non-vital teeth
• Occlusal instability
• Presence of orthodontic appliance
• Presence of removable partial dental prosthesis
• High risk of caries (presence of three or more active caries lesions)
• Xerostomia
• Bruxism
• Patients allergic to base materials monomers
• Patients who do not accept the project conditions

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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18 participants in 3 patient groups

Clearfil SE

Active Comparator group

Description:

Group containing 10-MDP and HEMA monomers

Treatment:

Other: composite resin restoration

Optibond All-in-One

Active Comparator group

Description:

Group containing HEMA monomer

Treatment:

Other: composite resin restoration

Prime & Bond Universal

Active Comparator group

Description:

Control Group containing other monomers

Treatment:

Other: composite resin restoration