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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-12

Study Completion Date

2022-02-12

Brief Summary

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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.

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Detailed Description

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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

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Non Carious Cervical Lesion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Clearfil SE

Group containing 10-MDP and HEMA monomers

Group Type ACTIVE_COMPARATOR

composite resin restoration

Intervention Type OTHER

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.

Optibond All-in-One

Group containing HEMA monomer

Group Type ACTIVE_COMPARATOR

composite resin restoration

Intervention Type OTHER

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.

Prime & Bond Universal

Control Group containing other monomers

Group Type ACTIVE_COMPARATOR

composite resin restoration

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Other Intervention Names

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composite resin restorations with Clearfil SE adhesive composite resin restorations with Optibond All-in-One adhesive composite resin restorations with Prime & Bond Universal adhesive

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes