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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02481700
Other study ID # S57824
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 10, 2015
Est. completion date June 2020

Study information

Verified date October 2020
Source Universitaire Ziekenhuizen Leuven
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

The aim of this study is to get a clear view on current practice of surgical third molar removal in Belgium and the association with morbidity and complications.

For this prospective cohort study, patients who visit the outpatient department of Oral and Maxillofacial Surgery of the University Hospitals Leuven or hospitals affiliated with the Flemish Hospital Network will be participating. All included patients are referred from primary dental providers for the surgical removal of one or more third molars. Before participating, written informed consent will be recorded from all eligible subjects.

Patients consult one of the oral and maxillofacial surgeons or residents working on the department of the University Hospitals Leuven for the removal of third molars. In the standard procedure, patients are not routinely clinically monitored after one week at the department.

Pre-operative, operative and postoperative data will be collected through a questionnaire, extracted data from the patient's medical file and panoramic radiography. The surgeon's individual operation technique will be registered through a one-off questionnaire. The questionnaires are taken at the same time of consultation and includes a maximum of 8 questions per time and are considered as non-invasive and a minimal burden for the patient. Postoperatively, patients record their recovery status and ability to resume daily- and work activities at day 3 and 10 by using a dairy system and, if necessary, revisit the outpatient department of oral and maxillofacial surgery.


Recruitment information / eligibility

Status Completed
Enrollment 6010
Est. completion date June 2020
Est. primary completion date June 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 12 Years and older
Eligibility Inclusion Criteria:

- referred for the removal of one or more third molars

Exclusion Criteria:

- other concomitant oral procedures in the same surgical session

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Third molar removal
The surgical removal of third molars

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Universitaire Ziekenhuizen Leuven

Outcome

Type Measure Description Time frame Safety issue
Primary Morbidity Assessing pain, trismus, swelling and neurosensory disturbances 10 days
Secondary Resuming daily activities Household, work, studies 10 days
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