Completed

NCT Number: NCT02419157

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

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.

Completed

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Key information

Conditions

Selective Enamel Etching in Dental Restorations

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Selective enamel etching with 36% phosphoric acid

Drug

Etch: selective 36% phosphoric acid enamel etching

Other names: 36% phosphoric acid

No selective enamel etching with 36% phosphoric acid

Drug

Non-etch: without phosphoric acid selective enamel etching

Other names: Without 36% phosphoric acid

Clearfil SE Bond

Device

Xeno V

Device

Primary outcomes

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

Time frame: Baseline, 3, 6, 12, 18 and 24 months

Secondary outcomes

Restoration marginal integrity as measured by modified U.S. Public Health Service evaluation criteria at baseline, 3, 6, 12, 18 and 24 months

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: Baseline, 3, 6, 12, 18 and 24 months

Sponsors and collaborators

Lead sponsor

University of Guarulhos

Other

Registry information

Official study title

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

Important dates

Study start: 2012
Primary completion: 2014
Study completion: 2014
First posted: Apr 17, 2015
Registry last updated: Apr 17, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.