Secondary CariesNCT05118100
Effectiveness of Adhesive Containing MDPB
An observational study of Secondary Caries, run by Radboud University Medical Center.
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). Read more about this study
- Who is it for?
- Ages 6 years and older
- Conditions the study is for
- Secondary Caries
- What is being tested?
- Clearfil Protect Bond and Clearfil SE Bond
- How many people
- 5,102 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2015to 30 Jun 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients who visited one of the participating general dental practices during the study period needing at least one dental restoration
Who may be able to join
- Needing at least one dental restoration
Who cannot join
- Opted out of data collection
About this study
Official title: 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.
- Conditions
- Secondary Caries
- Being tested
- Clearfil Protect Bond, Clearfil SE Bond
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clearfil Protect BondDrug
Also called 12-Methacryloyloxydodecylpyridiniumbromide
An adhesive is used routinely when placing resin composite restorations. This group receives a commercially available adhesive containing an antibacterial monomer (MDPB)
Clearfil SE BondDrug
An adhesive is used routinely when placing resin composite restorations. This group receives a commercially available adhesive.
| Study group | Role | What they receive |
|---|---|---|
| Protect Bond | Restoration placed using Clearfil Protect Bond adhesive (Kuraray Noritake, Osaka, Japan) , which contains the antibacterial monomer MDPB (12-Methacryloyloxydodecylpyridiniumbromide) Receives: Drug: Clearfil Protect Bond | |
| SE Bond | Restoration placed using Clearfil SEBond adhesive (Kuraray Noritake, Osaka, Japan) Receives: Drug: Clearfil SE Bond |
What is being measured
The primary outcome is the main question the study is designed to answer.
Restoration survival
Time in years restoration has survived without needing dental re-intervention
Measured: up to 5 years
Secondary outcomes (1)
Failure through caries
Incidence of secondary caries leading to replacement of the restoration
Measured: up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2021
- Study start1 Jan 2015
- Primary completion30 Jun 2021
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Secondary CariesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5,102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05118100
- Sponsor's protocol ID
- 2021THKHOLL01
- Status last verified
- Oct 2021
- First submitted
- 27 Oct 2021
- Last updated
- 11 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonimized data will be published in the DANS-easy archive. The study description are available to anyone, and the data are available upon request.
Publications
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.
PubMed 37394389
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Adhesive Containing MDPB: a Practice-based Clinical Trial
- ClinicalTrials.gov ID
- NCT05118100
- Acronym / sponsor ID
- 2021THKHOLL01
- Conditions
- Secondary Caries
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5,102 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 11 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Protect Bond | – | Drug: Clearfil Protect BondRestoration placed using Clearfil Protect Bond adhesive (Kuraray Noritake, Osaka, Japan) , which contains the antibacterial monomer MDPB (12-Methacryloyloxydodecylpyridiniumbromide) |
| SE Bond | – | Drug: Clearfil SE BondRestoration placed using Clearfil SEBond adhesive (Kuraray Noritake, Osaka, Japan) |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who visited one of the participating general dental practices during the study period needing at least one dental restoration
Key inclusion criteria (1 listed)
- Needing at least one dental restoration
Key exclusion criteria (1 listed)
- Opted out of data collection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clearfil Protect BondAlso: 12-MethacryloyloxydodecylpyridiniumbromideAn adhesive is used routinely when placing resin composite restorations. This group receives a commercially available adhesive containing an antibacterial monomer (MDPB) | Drug | Protect Bond |
| Clearfil SE BondAn adhesive is used routinely when placing resin composite restorations. This group receives a commercially available adhesive. | Drug | SE Bond |
Primary outcome
Restoration survival
Time frame: up to 5 years
Time in years restoration has survived without needing dental re-intervention
1 secondary outcome
Failure through caries
Time frame: up to 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Nov 2021.
- Derived from this study: PubMed 37394389Hollanders 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.
- Individual participant dataSharing planned: Yes. Anonimized data will be published in the DANS-easy archive. The study description are available to anyone, and the data are available upon request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Secondary Caries, run by Radboud University Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Restoration survival (time frame: up to 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05118100, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Nov 2021.