Tooth Impacted Clinical Trial
— OTTO-SYSTOfficial title:
Systemic Inflammation After Wisdom Tooth Removal: a Case-control Study
| Verified date | February 2017 |
| Source | University of Pisa |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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 Blood will be also withdrawn to assess systemic inflammation and other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.
| Status | Completed |
| Enrollment | 40 |
| Est. completion date | June 30, 2016 |
| Est. primary completion date | June 15, 2009 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 65 Years |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| University of Pisa |
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Changes in C-reactive protein (CRP) | High-Sensitive plasmatic C-reactive protein | baseline, 24 and three months after the second extraction | |
| Secondary | Changes in plasma malondialdehyde (MDA) | plasma malondialdehyde | baseline, 24 and three months after the second extraction | |
| Secondary | Changes in lipoperoxides (LOOH) | lipoperoxides levels in plasma | baseline, 24 and three months after the second extraction | |
| Secondary | Changes in ferric-reducing antioxidant power (FRAP) | FRAP levels in plasma | baseline, 24 and three months after the second extraction | |
| Secondary | Changes in endothelial flow-mediated dilation (FMD) calculated as maximal percentual increase in diameter of the blood vessel above baseline | 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 |