Clinical evaluation of new adhesives approach for dental restorations
| ISRCTN | ISRCTN00627732 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN00627732 |
| Secondary identifying numbers | N/A |
- Submission date
- 18/01/2012
- Registration date
- 03/02/2012
- Last edited
- 03/02/2012
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Plain English summary of protocol
Background and study aims
Current dentin adhesives present high hydrophilicity and are prone to water absorption that adversely affects the durability of resindentin 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
Contact information
Scientific
Federal University of Para
Avenida Augusto Correa
Campus Universitário do Guamá
Faculdade de Odontologia
Belém
66000-000
Brazil
| Phone | +55 91 3229 7337 |
|---|---|
| honorato@ufpa.br |
Study information
| Study design | Single-center randomize interventional study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not currently available in web format, please use the contact details below to request a patient information sheet |
| 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. |
| Study objectives | 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(s) | Research Ethics Committee of the Federal University of Para (Brazil), 10 November 2010 ref: 0115.0.073.000-10. Report: 148/10 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 10/12/2010 |
| Completion date | 10/12/2015 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | 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. |
| Key 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 |
| Key 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 |
| Date of first enrolment | 10/12/2010 |
| Date of final enrolment | 10/12/2015 |
Locations
Countries of recruitment
- Brazil
Study participating centre
66000-000
Brazil
Sponsor information
University/education
Avenida Augusto Correa
Campus Universitário do Guamá
Faculdade de Odontologia
Belém
66000-000
Brazil
| Phone | +55 91 3201 7563 |
|---|---|
| mestradodonto@ufpa.br | |
| Website | http://www.portal.ufpa.br/ |
"ROR" |
https://ror.org/03q9sr818 |
Funders
Funder type
Government
No information available
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
