Condition category
Oral Health
Date applied
08/03/2006
Date assigned
08/03/2006
Last edited
19/08/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr M.H. Frank

ORCID ID

Contact details

Academic Medical Center (AMC)
Department of Oral and Maxillofacial Surgery
P.O. Box 22660
Amsterdam
1100 DD
Netherlands
+31 (0)20 5662300
m.h.frank@amc.uva.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

BLACK

Study hypothesis

Common traditional practice until now has been discontinuation of the antiplatelet therapy 7 to 10 days prior to dental surgery, but controlled prospective data in the literature to support this practice are lacking. The discontinuation of antiplatelet treatment to ensure an adequate hemostasis during and after dental surgery needs to be offset against the (rebound) risk of thrombo-embolic complications if this treatment is stopped.
The hypothesis is that antiplatelet therapy can safely be continued prior to dental surgery.

Ethics approval

Received from local medical ethics committee

Study design

Randomised double blind placebo controlled parallel group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Parodontitis apicalis, adult parodontitis, caries

Intervention

Patients will be randomised to continue their medication of anti-platelet agents during the ten days prior to the procedure or to stop treatment. The study will be double blind; hence, patients will receive their initial medication in the form of study medication or placebo in the form of study medication for ten days prior to their treatment.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Peri-procedural blood loss

Secondary outcome measures

1. Occurrence of thrombo-embolic events at 30 days follow-up
2. The predictive effect of measurements in DNA, blood and saliva on peri-procedural hemostasis and blood loss

Overall trial start date

01/09/2005

Overall trial end date

01/09/2007

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patient on antiplatelet therapy who has to be treated in the AMC at the Department of Oral and Maxillofacial surgery
2. Approval of the prescribing physician
3. At least 18 years old

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

145

Participant exclusion criteria

1. Known coagulation defect
2. Use of oral anticoagulant treatment (vitamin K antagonists) or therapeutic heparin
3. Severe kidney dysfunction (creatinine clearance <20 ml/min) or hepatic dysfunction
4. Unstable coronary artery disease
5. Patients younger than 18 years of age
6. Refusal to provide informed consent
7. Recent placement of a coronary stent (during the last 6 months)

Recruitment start date

01/09/2005

Recruitment end date

01/09/2007

Locations

Countries of recruitment

Netherlands

Trial participating centre

Academic Medical Center (AMC)
Amsterdam
1100 DD
Netherlands

Sponsor information

Organisation

Academic Medical Centre (AMC) (Netherlands)

Sponsor details

Department of Oral and Maxillofacial Surgery
P.O. Box 22660
Amsterdam
1100 DD
Netherlands

Sponsor type

Not defined

Website

Funders

Funder type

Hospital/treatment centre

Funder name

Academic Medical Center (AMC) Department of Oral- and Maxillofacial Surgery and Department of Internal Medicine (Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes