Epidemiological Study on the Surgical Removal of Third Molars

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02481700
Recruitment Status : Enrolling by invitation
First Posted : June 25, 2015
Last Update Posted : October 26, 2016
Information provided by (Responsible Party):
Universitaire Ziekenhuizen Leuven

Brief 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 7 by using a dairy system and, if necessary, revisit the outpatient department of oral and maxillofacial surgery.

Condition or disease Intervention/treatment
Impacted Third Molar Tooth Procedure: Third molar removal

Study Type : Observational [Patient Registry]
Estimated Enrollment : 10000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 7 Days
Official Title: Epidemiological Study on the Surgical Removal of Third Molars
Study Start Date : January 2015
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : September 2020

Intervention Details:
  • Procedure: Third molar removal
    The surgical removal of third molars by local or general anaesthesia

Primary Outcome Measures :
  1. Morbidity [ Time Frame: 7 days ]
    Assessing nerve injury and pain in follow-up

Secondary Outcome Measures :
  1. Resuming daily activities [ Time Frame: 7 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
All included patients are referred from primary dental providers for the surgical removal of one or more third molars

Inclusion Criteria:

  • referred for the removal of one or more third molars

Exclusion Criteria:

Responsible Party: Universitaire Ziekenhuizen Leuven Identifier: NCT02481700     History of Changes
Other Study ID Numbers: S57824
First Posted: June 25, 2015    Key Record Dates
Last Update Posted: October 26, 2016
Last Verified: October 2016

Additional relevant MeSH terms:
Tooth, Impacted
Tooth Diseases
Stomatognathic Diseases