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Clinical Trials/NCT03048175
NCT03048175CompletedNot Applicable

Systemic Inflammation After Wisdom Tooth Removal: a Case-control Study

University of Pisa0 sites40 target enrollmentStarted: April 19, 2007Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
40
Primary Endpoint
Changes in C-reactive protein (CRP)

Study Overview

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 Blood will be also withdrawn to assess systemic inflammation and other systemic parameters.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

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Investigator, Outcomes Assessor)

Masking Description

Code was assigned to each participant. No info on whether they belong to cases or control was given to researchers and statistician.

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Arms & Interventions

Cases: wisdom tooth pathology

Experimental

Subjects affected by bilateral wisdom tooth pathology, undergoing surgical removal

Intervention: Wisdom tooth removal (Procedure)

Controls: no wisdom tooth pathology

No Intervention

Subjects showing agenesia/previous extraction/no symptoms of the lower third molars.

Outcomes

Primary Outcomes

Changes in C-reactive protein (CRP)

Time Frame: baseline, 24 and three months after the second extraction

High-Sensitive plasmatic C-reactive protein

Secondary Outcomes

  • Changes in plasma malondialdehyde (MDA)(baseline, 24 and three months after the second extraction)
  • Changes in lipoperoxides (LOOH)(baseline, 24 and three months after the second extraction)
  • Changes in ferric-reducing antioxidant power (FRAP)(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(baseline, 24 and three months after the second extraction)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Filippo Graziani, DDS MClinDent PhD

Associate Professor

University of Pisa

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