Effectiveness of Adhesive Containing MDPB

Secondary Caries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05118100
• Other study ID #: 2021THKHOLL01
• Status: Completed
• Start date: January 1, 2015
• Est. completion date: June 30, 2021

Study information

• Verified date: October 2021
• Source: Radboud University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5102
• Est. completion date: June 30, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years and older

Eligibility

Inclusion Criteria:

• Needing at least one dental restoration

Exclusion Criteria:

• Opted out of data collection

Related Conditions & MeSH terms

• Secondary Caries

Intervention

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)
• Clearfil SE Bond
An adhesive is used routinely when placing resin composite restorations. This group receives a commercially available adhesive.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Radboud University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Restoration survival	Time in years restoration has survived without needing dental re-intervention	up to 5 years
Secondary	Failure through caries	Incidence of secondary caries leading to replacement of the restoration	up to 5 years