Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 1:05 AM
Ignite Modification Date:
2025-12-25 @ 1:05 AM
NCT ID:
NCT05962593
Brief 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.
Detailed 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.
Study:
NCT05962593
Study Brief:
Protocol Section:
NCT05962593