Condition category
Oral Health
Date applied
18/01/2012
Date assigned
03/02/2012
Last edited
03/02/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Current dentin adhesives present high hydrophilicity and are prone to water absorption that adversely affects the durability of resin–dentin bonds. The aim of this study is to assess the clinical behavior (durability) of composite resin restorations placed after the use of a less hydrophilic adhesive approach.

Who can participate?
Adult (male and female) individuals (18-65 years old) presenting at least 3 non-carious cervical lesions were recruited.

What does the study involve?
Placement of dental restorations by experienced operators and their evaluations for up to 5 years regarding the marginal adaptation/staining and retention.

What are the possible benefits and risks of participating?
The participants received dental restorations by experienced operators and the risks were the same of those regular clinical procedures. Defective restoration will be immediately replaced.

Where is the study run from?
The study has been developed in the clinical facilities of the Federal University of Pará /Brazil – School of Dentistry.

When is the study starting and how long is it expected to run for?
The restorations were placed in June/August, 2011. According to the previously established evaluation periods, the study will go on until August, 2016.

Who is funding the study?
1. CNPq (National Council for Research Development), part of The Ministry of Science and Technology.
2. Federal University of Pará
Who is the main contact?
Professor Mário Honorato Silva e Souza Júnior.
honorato@ufpa.br

Trial website

http://www.ufpa.br/posodonto (under construction)

Contact information

Type

Scientific

Primary contact

Prof Mário Souza

ORCID ID

Contact details

Federal University of Para
Avenida Augusto Correa
Campus Universitário do Guamá
Faculdade de Odontologia
Belém
66000-000
Brazil
+55 91 3229 7337
honorato@ufpa.br

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

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.

Acronym

Study hypothesis

The actual adhesive systems have presented high hydrophilicity, which implies in a long-term compromised interface due to the normal characteristics of the oral environment. Less hydrophilic systems may show a more stable dental/restoration interface in oral conditions

Null hypothesis:
There are no differences in the clinical aspects evaluated among the three adhesives approaches

Ethics approval

Research Ethics Committee of the Federal University of Para (Brazil), 10 November 2010 ref: 0115.0.073.000-10. Report: 148/10

Study design

Single-center randomize interventional study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not currently available in web format, please use the contact details below to request a patient information sheet

Condition

Oral health

Intervention

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 incrementally, 1mm each, which were photoactivated for 40 seconds using a LED source with 1.200 mW/cm2 output.

Experimental Groups:
1. SBMP - Scotchbond Multi Purpose (3M ESPE)
1.1. Enamel and dentin acid -etching (37% phosphoric acid)for 30 seconds, wash for 20 second and blot dry
1.2. Primer application (rubbing) for 20 seconds in dentin, gently air dry for 30 seconds
1.3. Adhesive application in enamel - dentin and photo activation for 10 seconds

Group EO - Easy One (3M ESPE)
1. Air-dry the dental surface
2. Application of the adhesive (rubbing) for 20 seconds in enamel and dentin, gently air-dry for 5 seconds and photo activation for 10 seconds.

Ethanol Wet Bonding
1. Enamel and dentin acid-etching (37% phosphoric acid) for 30 seconds, wash for 30 seconds and blot-dry
2. Application (rubbing) of 50 microliters of 50% ethanol in dentin for 10 seconds, left undisturbed for another 10 seconds.
3. Application (rubbing) of 50 microliters of 100% ethanol in dentin for 10 seconds, left undisturbed for another 10 seconds.
4. Application (rubbing) of hydrophobic primer ( 2mL of the SBMP adhesive + 10% in weight ethanol -100% ) in dentin for 20 seconds, gently air-dry for 30 seconds
5. Application of the SBMP Adhesive in enamel and dentin and photo activation for 10 seconds.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

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 outcome measures

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

Overall trial start date

10/12/2010

Overall trial end date

10/12/2015

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

100 - 120 teeth with non-carious class V lesions were initially selected. Eventually, 90 restorations (30 for each studied group) in 17 patients were obtained.

Participant 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

Recruitment start date

10/12/2010

Recruitment end date

10/12/2015

Locations

Countries of recruitment

Brazil

Trial participating centre

Federal University of Para
Belém
66000-000
Brazil

Sponsor information

Organisation

Federal University of Pará (Brazil)

Sponsor details

Avenida Augusto Correa
Campus Universitário do Guamá
Faculdade de Odontologia
Belém
66000-000
Brazil
+55 91 3201 7563
mestradodonto@ufpa.br

Sponsor type

University/education

Website

http://www.portal.ufpa.br/

Funders

Funder type

Government

Funder name

National Council for Research Development (CNPq) - Science and Technology Ministry (Brazil)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Federal University of Para (Brazil)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes