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Completed

NCT Number: NCT03048175

Acute Inflammation After Wisdom Tooth Removal

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 Blood will be also withdrawn to assess systemic inflammation and other systemic parameters.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

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Key information

Conditions

Tooth Impacted Stomatognathic Diseases Tooth Diseases Tooth, Impacted

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Wisdom tooth removal

Procedure

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.

Primary outcomes

  1. 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

  1. Changes in plasma malondialdehyde (MDA)

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

    plasma malondialdehyde

  2. Changes in lipoperoxides (LOOH)

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

    lipoperoxides levels in plasma

  3. Changes in ferric-reducing antioxidant power (FRAP)

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

    FRAP levels in plasma

  4. 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

Sponsors and collaborators

Lead sponsor

University of Pisa

Other

Registry information

Official study title

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

Acronym: OTTO-SYST

Important dates

Study start
2007
Primary completion
2009
Study completion
2016
First posted
Feb 9, 2017
Registry last updated
Feb 9, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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