Impacted Third Molar ToothNCT02481700
Epidemiological Study on the Surgical Removal of Third Molars
An observational study of Impacted Third Molar Tooth, run by Universitaire Ziekenhuizen KU Leuven.
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… Read more about this study
- Who is it for?
- Ages 12 years and olderHealthy volunteers can take part
- Conditions the study is for
- Impacted Third Molar Tooth
- What is being tested?
- Third molar removal
- Type of treatment
- Surgery or procedure
- How many people
- 6,010 participants
- Where
- No sites listed yet
- Study dates
- 10 Sep 2015to Jun 2020
- How long will I take part?
- 10 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: All included patients are referred from primary dental providers for the surgical removal of one or more third molars
Who may be able to join
- referred for the removal of one or more third molars
Who cannot join
- other concomitant oral procedures in the same surgical session
About this study
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.
Read more
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.
- Conditions
- Impacted Third Molar Tooth
- Being tested
- Third molar removal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Third molar removalProcedure or surgery
The surgical removal of third molars
What is being measured
The primary outcome is the main question the study is designed to answer.
Morbidity
Assessing pain, trismus, swelling and neurosensory disturbances
Measured: 10 days
Secondary outcomes (1)
Resuming daily activities
Household, work, studies
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2015 (estimated)
- Study start10 Sep 2015
- Primary completionJun 2020
- Study completionJun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Impacted Third Molar ToothStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 6,010 participants (actual)
- Target duration
- 10 Days
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02481700
- Sponsor's protocol ID
- S57824
- Status last verified
- Oct 2020
- First submitted
- 22 Jun 2015
- Last updated
- 8 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiological Study on the Surgical Removal of Third Molars
- ClinicalTrials.gov ID
- NCT02481700
- Acronym / sponsor ID
- S57824
- Conditions
- Impacted Third Molar Tooth
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 6,010 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- 10 Sep 2015 (actual)
- Primary completion
- Jun 2020 (actual)
- Study completion
- Jun 2020 (actual)
- First posted
- 25 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Days
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All included patients are referred from primary dental providers for the surgical removal of one or more third molars
Key inclusion criteria (1 listed)
- referred for the removal of one or more third molars
Key exclusion criteria (1 listed)
- other concomitant oral procedures in the same surgical session
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Third molar removalThe surgical removal of third molars | Procedure or surgery | – |
Primary outcome
Morbidity
Time frame: 10 days
Assessing pain, trismus, swelling and neurosensory disturbances
1 secondary outcome
Resuming daily activities
Time frame: 10 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Impacted Third Molar Tooth, run by Universitaire Ziekenhuizen KU Leuven.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Morbidity (time frame: 10 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2020.