Clinical trial NCT03048175: Acute Inflammation After Wisdom Tooth Removal
Official title: Systemic Inflammation After Wisdom Tooth Removal: a Case-control Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tooth Impacted
Keywords: C-reactive protein
Systemic inflammation
Third molar
Wisdom tooth
Lead sponsor: University of Pisa
Sponsor class: OTHER
First posted: 2017-02-09
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Case-control intervention trial: cases are treated for pathology. Controls do not have pathology.
Primary purpose: TREATMENT

Brief summary: 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 Blood will be also withdrawn to assess systemic inflammation and other systemic parameters.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.

Detailed description: Third molar extraction is one of the most frequent intervention in dentistry. Nevertheless, little is known about the systemic aspect of subjects with impacted or semi-impacted third molars and the possible effects of surgical removal on their systemic parameters. A case-control study of 40 subjects has been designed to evaluate i) the overall systemic inflammation and metabolism of subjects with bilateral third molars compared to subjects with no third molars and ii) the effect of bilateral removal in the immediate and medium postsurgical period. Systemic parameters are evaluated via high sensitive c reactive protein (CRP), lipids, fibrinogen, oxidative stress and endothelial function analysis.

Eligibility criteria: 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.

Primary outcomes:
measure: Changes in C-reactive protein (CRP)
timeFrame: baseline, 24 and three months after the second extraction
Secondary outcomes:
measure: Changes in plasma malondialdehyde (MDA)
timeFrame: baseline, 24 and three months after the second extraction
measure: Changes in lipoperoxides (LOOH)
timeFrame: baseline, 24 and three months after the second extraction
measure: Changes in ferric-reducing antioxidant power (FRAP)
timeFrame: baseline, 24 and three months after the second extraction
measure: Changes in endothelial flow-mediated dilation (FMD) calculated as maximal percentual increase in diameter of the blood vessel above baseline
timeFrame: baseline, 24 and three months after the second extraction
Other outcomes:
Locations:
Study officials:
References:
citation: Graziani F, D'Aiuto F, Gennai S, Petrini M, Nisi M, Cirigliano N, Landini L, Bruno RM, Taddei S, Ghiadoni L. Systemic Inflammation after Third Molar Removal: A Case-Control Study. J Dent Res. 2017 Dec;96(13):1505-1512. doi: 10.1177/0022034517722775. Epub 2017 Jul 31.