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

Not Applicable

Completed

• Conditions: Non Carious Cervical Lesion
• Interventions: Other: composite resin restoration

• Registration Number: NCT04756349
• Lead Sponsor: Universidade Federal do Para

Brief 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).

Study Timeline

• Study Start: 2020-02-12
• Study First Submitted: 2021-02-05
• Study First Submitted QC: 2021-02-11
• Primary Completion: 2021-02-12
• Study First Posted: 2021-02-16
• Study Completion: 2022-02-12
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-17
• Last Update Posted: 2022-05-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Prime & Bond Universal	composite resin restoration	Control Group containing other monomers
Clearfil SE	composite resin restoration	Group containing 10-MDP and HEMA monomers
Optibond All-in-One	composite resin restoration	Group containing HEMA monomer

Primary Outcome Measures

Name	Time	Method
Retention rate of restoration	02 years	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.

Secondary Outcome Measures

Name	Time	Method
Marginal staining rate of restoration	02 years	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).
Marginal Adaptation rate of restoration	02 years	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.

Trial Locations

Locations (1)

Para's Federal University; 🇧🇷 Belém, Pará, Brazil