NCT05118100

Effectiveness of Adhesive Containing MDPB

Effectiveness of Adhesive Containing MDPB: a Practice-based Clinical Trial

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 5,102 (actual)
• Sponsor: Radboud University Medical Center · Academic / Other
• Sex: All
• Age: 6 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Secondary Caries

Interventions

Type	Name	Description
DRUG	Clearfil Protect Bond	An adhesive is used routinely when placing resin composite restorations. This group receives a commercially available adhesive containing an antibacterial monomer (MDPB)
DRUG	Clearfil SE Bond	An adhesive is used routinely when placing resin composite restorations. This group receives a commercially available adhesive.

Timeline

• Start date: 2015-01-01
• Primary completion: 2021-06-30
• Completion: 2021-06-30
• First posted: 2021-11-11
• Last updated: 2021-11-11