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CompletedNCT02481700Updated Oct 8, 2020

Epidemiological Study on the Surgical Removal of Third Molars

An observational study in Impacted Third Molar Tooth, sponsored by Universitaire Ziekenhuizen KU Leuven. Completed. Open to participants aged 12 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-10-08.

Sponsored by Universitaire Ziekenhuizen KU Leuven · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
6,010
Ages
12 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Impacted Third Molar Tooth

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03

In context

Tooth, Impacted

195 studies on the registry are indexed under Tooth, Impacted; 20 are open to participants now.

This study's enrollment of 6,010 is above the median of 60 across 29 observational studies indexed under Tooth, Impacted.

Browse Tooth, Impacted studies →

Lead sponsor

Universitaire Ziekenhuizen KU Leuven is the lead sponsor of 928 studies on the registry; 261 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Years and older
Sexes eligible
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

Exclusion Criteria:

  • other concomitant oral procedures in the same surgical session
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
6,010 participants (actual)
Target follow-up
10 Days
Patient registry
Yes

Interventions

  • ProcedureThird molar removal

    The surgical removal of third molars

06

What researchers measure

Primary outcomes

  1. Morbidity

    Assessing pain, trismus, swelling and neurosensory disturbances

    Time frame: 10 days

Secondary outcomes

  1. Resuming daily activities

    Household, work, studies

    Time frame: 10 days

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 8, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02481700
Lead sponsor
Universitaire Ziekenhuizen KU Leuven
Responsible party
Sponsor
First posted
Jun 25, 2015
Start date
Sep 10, 2015
Primary completion
Jun 2020
Completion
Jun 2020
Last update
Oct 8, 2020

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2020. You cannot join it, but the record below documents what was studied.

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