Effectiveness of Adhesive Containing MDPB
- Conditions
- Secondary Caries
- Interventions
- Drug: Clearfil SE BondDrug: Clearfil Protect Bond
- Registration Number
- NCT05118100
- Lead Sponsor
- Radboud University Medical Center
- Brief Summary
9 general practices in the Netherlands were provided with two composite resin adhesives, each for a period of 9 months. One contained MDPB (Adhesive P), and the other one was used as a control (Adhesive S). Patient's age, SES, and caries risk, as well as tooth type/number, reason for restoration placement, used restorative material and bonding agent, and affected surfaces were recorded. All interventions carried out on these teeth in the next 6 years were extracted from the electronic patient records, along with their date, type, reason, and surfaces. Two dependent variables were defined: general failure, and failure due to secondary caries. All data handling and statistical analyses were carried out in R 4.0.5.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 5102
- Needing at least one dental restoration
- Opted out of data collection
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description SE Bond Clearfil SE Bond Restoration placed using Clearfil SEBond adhesive (Kuraray Noritake, Osaka, Japan) Protect Bond Clearfil Protect Bond Restoration placed using Clearfil Protect Bond adhesive (Kuraray Noritake, Osaka, Japan) , which contains the antibacterial monomer MDPB (12-Methacryloyloxydodecylpyridiniumbromide)
- Primary Outcome Measures
Name Time Method Restoration survival up to 5 years Time in years restoration has survived without needing dental re-intervention
- Secondary Outcome Measures
Name Time Method Failure through caries up to 5 years Incidence of secondary caries leading to replacement of the restoration