Clinical evaluation of new adhesives approach for dental restorations

A randomized, split-month clinical study comparing the ethanol wet bonding technique to 3 step etch-and-rinse and 1-step self-etching approaches prior the application of a composite resin in non-carious class V lesions in adults patients focusing on marginal adaptation / staining and retention using modified Ryge criteria.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN00627732

Enrollment

120

Registered

2012-02-03

Start date

2010-12-10

Completion date

Unknown

Last updated

2015-01-13

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

Conditions

Oral health Oral Health

Interventions

No cavity preparation (drilling) was performed. The restoration procedures were executed by one operator. After the adhesive procedures the composite resin (Filtek Z-350/ 3M ESPE) was placed increment

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Good oral hygiene and periodontal conditions 2. Low caries-risk 3. Good occlusal stability and no significant bruxism or clenching 4. At least 3 (6,9,12...) supragengival non-carious class V lesions 5. Male and female participants 6. Aged 18 - 65 years

Exclusion criteria

Exclusion criteria: 1. Poor oral hygiene and periodontal conditions 2. High caries-risk 3. Evidence of bruxism and clenching causing visible bright wear areas 4. Use of partial removable prosthodontics 5. Complete dentures or orthodontic appliances

Design outcomes

Primary

Measure	Time frame
The modified Ryge criteria will be applied to retention, after 6 mouths, 1, 2, 3 and 5 years Retention 1. Restoration totally present 2. Restoration partially or totally lost	—

Secondary

Measure	Time frame
The modified Ryge criteria will be applied to marginal adaptation / staining, after 6 months, 1, 2, 3 and 5 years. Marginal Staining Criteria 1. No staining 2. Superficial staining removed by polishing procedures 3. Deep staining Marginal adaptation: 1. No gap 2. Minor gap but no dentin exposed 3. Major gap with dentin exposed	—

Countries

Brazil

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026