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

Universidade Federal do Para18 enrolled

Overview

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.

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Non Carious Cervical Lesion

Interventions

composite resin restorationOTHER

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.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Para's Federal University

Belém, Pará, Brazil

Outcomes

Primary Outcomes

Retention rate of restoration

The retention rate will be assessed following the USPHS (United States Public Health) guidelines with the following classifications (acronyms): Alpha = retained. Charlie = mobility or loss.

Time frame: 01 year

Retention rate of restoration

The retention rate will be assessed following the USPHS (United States Public Health) guidelines with the following classifications (acronyms): Alpha = retained. Charlie = mobility or loss.

Time frame: 02 years

Secondary Outcomes

Marginal staining rate of restoration

The marginal staining rate will be assessed following the USPHS (United States Public Health) guidelines with the following classifications (acronyms): Alpha = no staining. Bravo = superficial staining (localized or generalized). Charlie = deep staining (localized or generalized).

Time frame: 01 year

Marginal staining rate of restoration

Time frame: 02 years

Marginal Adaptation rate of restoration

The marginal adaptation rate will be assessed following the USPHS (United States Public Health) guidelines with the following classifications (acronyms): Alpha = no visible evidence of a crack along the edge, the explorer will not penetrate. Bravo = visible evidence of a crack along the margin, dentin unexposed, clinically acceptable. Charlie = explorer penetrates the crack, dentin exposed, clinically unacceptable.

Time frame: 01 year

Data from ClinicalTrials.gov

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