Effectiveness of Adhesive Containing MDPB

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.

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Key information

Conditions

Secondary Caries

Age range

6 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Needing at least one dental restoration

Exclusion criteria

Opted out of data collection

Treatment and study plan

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)

Other names: 12-Methacryloyloxydodecylpyridiniumbromide

Clearfil SE Bond

Drug

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

Primary outcomes

Restoration survival

Time frame: up to 5 years

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

Secondary outcomes

Failure through caries

Time frame: up to 5 years

Incidence of secondary caries leading to replacement of the restoration

Sponsors and collaborators

Lead sponsor

Radboud University Medical Center

Other

Registry information

Official study title

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

Important dates

Study start: 2015
Primary completion: 2021
Study completion: 2021
First posted: Nov 11, 2021
Registry last updated: Nov 11, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed