Different Inflammatory Biomarkers With Surgical Removal of Mandibular Third Molars

Surgical Removal of Mandibular Third Molars. Inflammation, Infection, Pain and Complications. Different Inflammatory Biomarkers With Surgical Removal of Mandibular Third Molars

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.

Study Overview

• Status: Recruiting
• Conditions: Wisdom Teeth
• Intervention / Treatment: Other: Telephone call

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 Type: Interventional
• Enrollment (Estimated): 124
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marie Kjærgaard Larsen, PhD; Phone Number: +4520122781; Email: marie.kjaergaard@sund.ku.dk
• Study Contact Backup: Name: Simon St Jensen, Prof; Phone Number: +4535 33 30 52; Email: simon.storgaard.jensen@sund.ku.dk

Study Locations

• Denmark
  • Copenhagen, Denmark, 2100
    • Recruiting
    • Rigshospitalet
    • Contact: Simon St Jensen, Prof; Phone Number: +4535 33 30 52; Email: simon.storgaard.jensen@sund.ku.dk
    • Contact: Marie Kj Larsen, PhD; Phone Number: 20122781; Email: marie.kjaergaard@sund.ku.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Wisdom teeth

Exclusion Criteria:

• No wisdom teeth

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Telephone call; A postoperative telephone call	Other: Telephone call; The patients will be randomized for a postoperative telephone call
No Intervention: No telephone call

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Inflammation	High sensitive C-reactive protein	3 months postoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain score	NRS	1-7 days postoperative

Collaborators and Investigators

• Sponsor: University of Copenhagen
• Investigators: Principal Investigator: Marie Kj Larsen, PhD, University of Copenhagen

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2023
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): June 1, 2024

Study Registration Dates

• First Submitted: July 18, 2023
• First Submitted That Met QC Criteria: July 18, 2023
• First Posted (Actual): July 27, 2023

Study Record Updates

• Last Update Posted (Actual): July 27, 2023
• Last Update Submitted That Met QC Criteria: July 18, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: pain; wisdom teeth; inflamation
• Other Study ID Numbers: H 22029533

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No