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

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04756349

Enrollment

Registered

2021-02-16

Start date

2020-02-12

Completion date

2022-02-12

Last updated

2022-05-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non Carious Cervical Lesion

Keywords

adhesives, dental bonding

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).

Interventions

OTHERcomposite 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Retention rate of restoration	01 year	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

Measure	Time frame	Description
Marginal staining rate of restoration	01 year	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	01 year	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.

Other

Measure	Time frame	Description
Postoperative sensitivity rate of restoration	01 year	present or absent
Secondary caries rate of restoration	01 year	present or absent

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026