Effectiveness of Adhesive Containing MDPB

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

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.

Study Overview

• Status: Completed
• Conditions: Secondary Caries
• Intervention / Treatment: Drug: Clearfil Protect Bond; Drug: Clearfil SE Bond

• Study Type: Observational
• Enrollment (Actual): 5102

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients who visited one of the participating general dental practices during the study period needing at least one dental restoration

Description

Inclusion Criteria:

• Needing at least one dental restoration

Exclusion Criteria:

• Opted out of data collection

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Protect Bond; Restoration placed using Clearfil Protect Bond adhesive (Kuraray Noritake, Osaka, Japan) , which contains the antibacterial monomer MDPB (12-Methacryloyloxydodecylpyridiniumbromide)	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); Other Names: 12-Methacryloyloxydodecylpyridiniumbromide
SE Bond; Restoration placed using Clearfil SEBond adhesive (Kuraray Noritake, Osaka, Japan)	Drug: Clearfil SE Bond; An adhesive is used routinely when placing resin composite restorations. This group receives a commercially available adhesive.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Restoration survival	Time in years restoration has survived without needing dental re-intervention	up to 5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Failure through caries	Incidence of secondary caries leading to replacement of the restoration	up to 5 years

Collaborators and Investigators

• Sponsor: Radboud University Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2015
• Primary Completion (Actual): June 30, 2021
• Study Completion (Actual): June 30, 2021

Study Registration Dates

• First Submitted: October 27, 2021
• First Submitted That Met QC Criteria: November 10, 2021
• First Posted (Actual): November 11, 2021

Study Record Updates

• Last Update Posted (Actual): November 11, 2021
• Last Update Submitted That Met QC Criteria: November 10, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: 2021THKHOLL01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Anonimized data will be published in the DANS-easy archive. The study description are available to anyone, and the data are available upon request.
• IPD Sharing Time Frame: Data will become available upon study publication.
• IPD Sharing Access Criteria: Any individual requesting access through the archive will obtain access
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No