Acute Inflammation After Wisdom Tooth Removal (OTTO-SYST)
Systemic Inflammation After Wisdom Tooth Removal: a Case-control Study
Third molar (wisdom teeth) extraction is one of the most frequent intervention in dentistry. Nevertheless, little is known about the level of general body inflammation of subjects with impacted or semi-impacted third molars. Moreover, The possible effects of surgical removal of wisdom teeth on the overall health are not known.
Thus, a study in which 40 subjects has been designed. Twenty subjects were affected by bilateral wisdom tooth pathology necessitating for extraction of both teeth. Control group comprised 20 subjects with absence of wisdom teeth or completely erupted wisdom teeth without pathology associated to or history of previous extraction of both wisdom teeth.
In both groups a medical and dental examination will be performed at the baseline and 3 months after baseline for the control group or after the second third molar extraction in the control group. Blood will be also withdrawn to assess systemic inflammation and other systemic parameters.
Parameter were evaluated via high sensitive c reactive protein (CRP), lipids, fibrinogen, oxidative stress and endothelial function analysis.
Study Overview
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- cases: bilateral wisdom tooth pathology.
- control: agenesia/previous extraction/no symptoms of the lower third molars.
Exclusion Criteria:
- younger than 18 years and older than 65 years;
- pregnant or lactating females;
- females using contraceptive methods;
- suffering from any systemic illness;
- undergoing any pharmacological treatment within 30 days prior to the inclusion
- patients affected by periodontal disease (radiographic diagnosis of vertical bone defects or bone resorption equal to 20% of the root length);
- patients with periapical and periradicular radiolucent areas X-ray detectable;
- patients unable to participate to study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Cases: wisdom tooth pathology
Subjects affected by bilateral wisdom tooth pathology, undergoing surgical removal
|
After inferior dental and buccal nerve anesthesia a triangular full thickness flap with releasing incision on the mesio-buccal aspect of the second molar is designed.
Ostectomy is then performed and tooth is sectioned and gently elevated.
Once all the tooth components are extracted, the socket is carefully inspected and flap is sutured with interrupted sutures.
|
|
No Intervention: Controls: no wisdom tooth pathology
Subjects showing agenesia/previous extraction/no symptoms of the lower third molars.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Changes in C-reactive protein (CRP)
Time Frame: baseline, 24 and three months after the second extraction
|
High-Sensitive plasmatic C-reactive protein
|
baseline, 24 and three months after the second extraction
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Changes in plasma malondialdehyde (MDA)
Time Frame: baseline, 24 and three months after the second extraction
|
plasma malondialdehyde
|
baseline, 24 and three months after the second extraction
|
|
Changes in lipoperoxides (LOOH)
Time Frame: baseline, 24 and three months after the second extraction
|
lipoperoxides levels in plasma
|
baseline, 24 and three months after the second extraction
|
|
Changes in ferric-reducing antioxidant power (FRAP)
Time Frame: baseline, 24 and three months after the second extraction
|
FRAP levels in plasma
|
baseline, 24 and three months after the second extraction
|
|
Changes in endothelial flow-mediated dilation (FMD) calculated as maximal percentual increase in diameter of the blood vessel above baseline
Time Frame: baseline, 24 and three months after the second extraction
|
Endothelium-dependent response of the brachial artery in response to increased blood flow by high resolution ultrasound with a 7.5 MHz linear array transducer
|
baseline, 24 and three months after the second extraction
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2198
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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