Effectiveness of Adhesive Containing MDPB

NCT05118100 | Completed

• 1 other identifier: 2021THKHOLL01
• Study Type: observational
• Target: 5,102
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Secondary Caries

Outcome Measures

Primary Outcomes (1)

• Restoration survival

  Time in years restoration has survived without needing dental re-intervention

  up to 5 years

Secondary Outcomes (1)

• Failure through caries

  up to 5 years

Study Arms (2)

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

SE Bond

Restoration placed using Clearfil SEBond adhesive (Kuraray Noritake, Osaka, Japan)

Drug: Clearfil SE Bond

Interventions

Clearfil Protect Bond DRUG

An adhesive is used routinely when placing resin composite restorations. This group receives a commercially available adhesive containing an antibacterial monomer (MDPB)

Also known as: 12-Methacryloyloxydodecylpyridiniumbromide

Protect Bond

Clearfil SE Bond DRUG

An adhesive is used routinely when placing resin composite restorations. This group receives a commercially available adhesive.

SE Bond

Eligibility Criteria

• Age: 6 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• Needing at least one dental restoration

You may not qualify if:

• Opted out of data collection

Sponsors & Collaborators

• Radboud University Medical Center: lead

Related Publications (1)

• Hollanders ACC, Kuper NK, Bronkhorst EM, Laske M, Huysmans MCDNJM. Effectiveness of adhesive containing MDPB: A practice-based clinical trial. Dent Mater. 2023 Aug;39(8):756. doi: 10.1016/j.dental.2023.06.011. Epub 2023 Jul 1.

  PMID: 37394389 DERIVED

MeSH Terms

Interventions

Clearfil Protect Bond; Clearfil SE Bond

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2021
• First Posted: November 11, 2021
• Study Start: January 1, 2015
• Primary Completion: June 30, 2021
• Study Completion: June 30, 2021
• Last Updated: November 11, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Data will become available upon study publication.
• Access Criteria: Any individual requesting access through the archive will obtain access