Different Inflammatory Biomarkers With Surgical Removal of Mandibular Third Molars

Sponsor

University of Copenhagen (Other)

Overall Status

Recruiting

CT.gov ID

NCT05962593

Collaborator

(none)

124

Enrollment

Location

Arms

Anticipated Duration (Months)

10.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Wisdom Teeth	Other: Telephone call	N/A

Detailed Description

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 Design

Study Type:

Interventional

Anticipated Enrollment :

124 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Diagnostic

Official Title:

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

Actual Study Start Date :

Jun 1, 2023

Anticipated Primary Completion Date :

Jun 1, 2024

Anticipated Study Completion Date :

Jun 1, 2024

Arms and Interventions

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 No telephone call

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

No telephone call

Outcome Measures

Primary Outcome Measures

Inflammation [3 months postoperative]
High sensitive C-reactive protein

Secondary Outcome Measures

Pain score [1-7 days postoperative]
NRS

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Wisdom teeth

Exclusion Criteria:

No wisdom teeth

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Rigshospitalet	Copenhagen		Denmark	2100

Sponsors and Collaborators

University of Copenhagen

Investigators

Principal Investigator: Marie Kj Larsen, PhD, University of Copenhagen

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of Copenhagen

ClinicalTrials.gov Identifier:

NCT05962593

Other Study ID Numbers:

H 22029533

First Posted:

Jul 27, 2023

Last Update Posted:

Jul 27, 2023

Last Verified:

Jun 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Keywords provided by University of Copenhagen

wisdom teeth

inflamation

pain

Study Results

No Results Posted as of Jul 27, 2023