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Bleeding risk after wisdom tooth removal in healty individuals


- candidate number24366
- NTR NumberNTR5917
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR18-mei-2016
- Secondary IDs2015.156 VuMC METC
- Public TitleBleeding risk after wisdom tooth removal in healty individuals
- Scientific TitleRisk factors associated haemorrhagic complications after third molar removal in healthy indicuduals
- ACRONYM'Gezond Verstand Studie'
- hypothesisWe hypothesise that third molar removal is a safe treatment to perform in healthy patients, but that the experience of a hemmorrhagic complication varies greatly between the patients and surgeons.
- Healt Condition(s) or Problem(s) studiedBleeding, Wisdom tooth
- Inclusion criteriaHealthy patients who are referred to the OMFS department for the removal of a third molar or multiple third molars.
- Exclusion criteria- patients unable to give informed consent
- systemic co-morbidity
- the use of medication which influence the hemostasis (in the 10 days before treatment)
- removal of other teeth than the third molar
- removal of third molar under general anesthesia
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-apr-2016
- planned closingdate1-jan-2018
- Target number of participants1000
- Interventionsnone, observational
- Primary outcomepostoperative bleeding incidence and severity
- Secondary outcomeRiksfactors for postoperative bleeding:
- treatment related: lokal hemostatic measurements, number of teeth removed, postoperative medication etc.
- patient related: gender, age, smoking etc.
- Timepointsday 1: treatment by OMFS
if applicable: a questionaire for OMFS in case of postoperative bleeding complications
day 7: delivery of online questionaire on bleeding complications
if applicable, day 10 reminder day 14: end of follow-up
- Trial web site-
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESMD W.M.H. Rademacher
- CONTACT for SCIENTIFIC QUERIESMD W.M.H. Rademacher
- Sponsor/Initiator Department of Medical and Dental interaction, Academic Center for Dentistry
- Funding
(Source(s) of Monetary or Material Support)
Royal Dutch Society for Dentistry
- Publications
- Brief summary
- Main changes (audit trail)
- RECORD18-mei-2016 - 9-jul-2016


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