Selective Enamel Etching in Self-etching Adhesives: a 2-year Clinical Trial

Effectiveness of One- and Two-step Self-etching Adhesives Applied With or Without Selective Enamel Etching: a 2-year Randomized Controlled Clinical Trial

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02419157

Enrollment

Registered

2015-04-17

Start date

2012-10-31

Completion date

2014-10-31

Last updated

2015-04-17

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

Conditions

Selective Enamel Etching in Dental Restorations

Keywords

Cervical lesions, Clinical trial, Self-etch adhesive

Brief summary

The purpose of this study is to evaluate the clinical effectiveness of non-carious cervical lesions (NCCLs) restored with two self-etching adhesive systems applied with or without selective enamel etching.

Detailed description

The purpose of this study is to evaluate the clinical effectiveness of non-carious cervical lesions (NCCLs) restored with two self-etching adhesive systems: Clearfil SE Bond (Kuraray Noritake, Japan) and Xeno V + (Dentsply De Trey, Germany) applied with or without 36% phosphoric acid enamel etching. Assessments were at baseline, 3, 6, 12, 18 and 24 months of clinical service.

Interventions

DRUGSelective enamel etching with 36% phosphoric acid

Etch: selective 36% phosphoric acid enamel etching

DRUGNo selective enamel etching with 36% phosphoric acid

Non-etch: without phosphoric acid selective enamel etching

DEVICEClearfil SE Bond

DEVICEXeno V

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Be at least 18 years; * Present at least 4 NCCLs in vital teeth with margins in enamel and dentin (and its largest area in dentin), independently of teeth location; * Non-smoking; * Read and sign the Statement of Informed Consent.

Exclusion criteria

* Compromised medical history; * Severe or chronic periodontitis; * Extreme caries sensitivity; * Heavy bruxism; * Under orthodontic treatment; * Poor oral hygiene; * Smokers.

Design outcomes

Primary

Measure	Time frame
Restoration retention rate as measured by modified U.S. Public Health Service evaluation criteria at baseline, 3, 6, 12, 18 and 24 months	Baseline, 3, 6, 12, 18 and 24 months

Secondary

Measure	Time frame
Restoration marginal integrity as measured by modified U.S. Public Health Service evaluation criteria at baseline, 3, 6, 12, 18 and 24 months	Baseline, 3, 6, 12, 18 and 24 months
Restoration marginal staining as measured by modified U.S. Public Health Service evaluation criteria at baseline, 3, 6, 12, 18 and 24 months	Baseline, 3, 6, 12, 18 and 24 months
Secondary caries as measured by modified U.S. Public Health Service evaluation criteria at baseline, 3, 6, 12, 18 and 24 months	Baseline, 3, 6, 12, 18 and 24 months
Post-operative sensitivity as measured by modified U.S. Public Health Service evaluation criteria at baseline, 3, 6, 12, 18 and 24 months	Baseline, 3, 6, 12, 18 and 24 months
Pulp vitality as measured by modified U.S. Public Health Service evaluation criteria at baseline, 3, 6, 12, 18 and 24 months	Baseline, 3, 6, 12, 18 and 24 months

Outcome results

None listed

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