Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05962593 |
| Other study ID # |
H 22029533 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
June 1, 2023 |
| Est. completion date |
June 2024 |
Study information
| Verified date |
June 2023 |
| Source |
University of Copenhagen |
| Contact |
Marie Kjærgaard Larsen, PhD |
| Phone |
+4520122781 |
| Email |
marie.kjaergaard[@]sund.ku.dk |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Removal of mandibular third molars (M3s) is the most frequently performed surgical
intervention undertaken in dentistry. The indications and timing of surgical removal of M3s
has been a matter of international and national debate, and especially prophylactic removal
of M3s is controversial.
Description:
Removal of mandibular third molars (M3s) is the most frequently performed surgical
intervention undertaken in dentistry. The indications and timing of surgical removal of M3s
has been a matter of international and national debate, and especially prophylactic removal
of M3s is controversial.
It is well documented that periodontally compromised patients are characterized by elevated
levels of systemic low-grade inflammation which can affect their general health and
contribute to development and aggravation of a number of chronic diseases including diabetes
mellitus and cardiovascular disorders. Inflammatory changes are frequent around erupted,
semi-erupted and retained M3s. However, only a few under-powered studies have addressed the
relationship between the presence of M3s and the level of systemic low-grade inflammation.
Conservative guidelines recommend not to remove M3s until subjective and/or objective signs
of infection are observed. Overall, these guidelines result in a relatively equal
distribution of surgically removed M3s over the age span of a population. In contrast, more
proactive guidelines recommend removal of M3s that are not expected to erupt into functional
occlusion leading to frequent removal of M3s in the young population. Surgical removal of M3s
are associated with a varying degree of pain, facial swelling and the patients are on average
sick leave for 2-3 days. Furthermore, complications as nerve damage, infection, bleeding and
jaw fracture can occur. Therefore, unnecessary removal of M3s should be avoided. However, the
risk and severity of postoperative sequelae and complications is known to increase
significantly with age. Hence, the crucial point determining indications for surgical removal
of M3s is to balance the risk of developing local and systemic disease against the risk of
complications after surgical removal.
The present project will investigate the systemic impact of retaining or removing M3s by
measuring low-grade systemic inflammation markers in blood and saliva. To further explore
measures to reduce postoperative complications, discomfort, and patient satisfaction, the
effect of prophylactic antibiotics, pre-emptive analgesics, and a postoperative follow-up
telephone call, will be investigated.
The project consists of six prospective studies that will include more than 800 patients and
surgical removal of more than 1,000 mandibular third molars. It is expected that the project
will contribute with important information on the impact of mandibular third molars on
general health and prophylactic modalities that can influence postoperative sequelae and
complications following surgical removal of mandibular third molars.
