We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Epidemiological Study on the Surgical Removal of Third Molars

This study is enrolling participants by invitation only.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02481700
First Posted: June 25, 2015
Last Update Posted: October 26, 2016
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.
Information provided by (Responsible Party):
Universitaire Ziekenhuizen Leuven
  Purpose

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 Intervention
Impacted Third Molar Tooth Procedure: Third molar removal

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 7 Days
Official Title: Epidemiological Study on the Surgical Removal of Third Molars

Further study details as provided by Universitaire Ziekenhuizen Leuven:

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


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

Estimated Enrollment: 10000
Study Start Date: January 2015
Estimated Study Completion Date: September 2020
Estimated Primary Completion Date: September 2020 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: Third molar removal
    The surgical removal of third molars by local or general anaesthesia
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
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
Criteria

Inclusion Criteria:

  • referred for the removal of one or more third molars

Exclusion Criteria:

  Contacts and Locations
No Contacts or Locations Provided
  More Information

Responsible Party: Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT02481700     History of Changes
Other Study ID Numbers: S57824
First Submitted: June 22, 2015
First Posted: June 25, 2015
Last Update Posted: October 26, 2016
Last Verified: October 2016

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