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Effectiveness of Adhesive Containing MDPB

NCT ID: NCT05118100

Last Updated: 2021-11-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

5102 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-01-01

Study Completion Date

2021-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Secondary Caries

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Protect Bond

Restoration placed using Clearfil Protect Bond adhesive (Kuraray Noritake, Osaka, Japan) , which contains the antibacterial monomer MDPB (12-Methacryloyloxydodecylpyridiniumbromide)

Clearfil Protect Bond

Intervention Type DRUG

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

SE Bond

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

Clearfil SE Bond

Intervention Type DRUG

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

Interventions

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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)

Intervention Type DRUG

Clearfil SE Bond

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

Intervention Type DRUG

Other Intervention Names

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12-Methacryloyloxydodecylpyridiniumbromide

Eligibility Criteria

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Inclusion Criteria

* Needing at least one dental restoration

Exclusion Criteria

* Opted out of data collection
Minimum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Radboud University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

References

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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.

Reference Type DERIVED
PMID: 37394389 (View on PubMed)

Other Identifiers

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2021THKHOLL01

Identifier Type: -

Identifier Source: org_study_id