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Acute Inflammation After Wisdom Tooth Removal (OTTO-SYST)

Primary Purpose

Tooth Impacted

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Wisdom tooth removal
Sponsored by
University of Pisa
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tooth Impacted focused on measuring C-reactive protein, Systemic inflammation, Third molar, Wisdom tooth

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Cases: wisdom tooth pathology

    Controls: no wisdom tooth pathology

    Arm Description

    Subjects affected by bilateral wisdom tooth pathology, undergoing surgical removal

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

    Outcomes

    Primary Outcome Measures

    Changes in C-reactive protein (CRP)
    High-Sensitive plasmatic C-reactive protein

    Secondary Outcome Measures

    Changes in plasma malondialdehyde (MDA)
    plasma malondialdehyde
    Changes in lipoperoxides (LOOH)
    lipoperoxides levels in plasma
    Changes in ferric-reducing antioxidant power (FRAP)
    FRAP levels in plasma
    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

    Full Information

    First Posted
    February 6, 2017
    Last Updated
    February 8, 2017
    Sponsor
    University of Pisa
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03048175
    Brief Title
    Acute Inflammation After Wisdom Tooth Removal
    Acronym
    OTTO-SYST
    Official Title
    Systemic Inflammation After Wisdom Tooth Removal: a Case-control Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    April 19, 2007 (Actual)
    Primary Completion Date
    June 15, 2009 (Actual)
    Study Completion Date
    June 30, 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Pisa

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Tooth Impacted
    Keywords
    C-reactive protein, Systemic inflammation, Third molar, Wisdom tooth

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Case-control intervention trial: cases are treated for pathology. Controls do not have pathology.
    Masking
    InvestigatorOutcomes 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.
    Allocation
    Non-Randomized
    Enrollment
    40 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Cases: wisdom tooth pathology
    Arm Type
    Experimental
    Arm Description
    Subjects affected by bilateral wisdom tooth pathology, undergoing surgical removal
    Arm Title
    Controls: no wisdom tooth pathology
    Arm Type
    No Intervention
    Arm Description
    Subjects showing agenesia/previous extraction/no symptoms of the lower third molars.
    Intervention Type
    Procedure
    Intervention Name(s)
    Wisdom tooth removal
    Intervention Description
    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 Outcome Measure Information:
    Title
    Changes in C-reactive protein (CRP)
    Description
    High-Sensitive plasmatic C-reactive protein
    Time Frame
    baseline, 24 and three months after the second extraction
    Secondary Outcome Measure Information:
    Title
    Changes in plasma malondialdehyde (MDA)
    Description
    plasma malondialdehyde
    Time Frame
    baseline, 24 and three months after the second extraction
    Title
    Changes in lipoperoxides (LOOH)
    Description
    lipoperoxides levels in plasma
    Time Frame
    baseline, 24 and three months after the second extraction
    Title
    Changes in ferric-reducing antioxidant power (FRAP)
    Description
    FRAP levels in plasma
    Time Frame
    baseline, 24 and three months after the second extraction
    Title
    Changes in endothelial flow-mediated dilation (FMD) calculated as maximal percentual increase in diameter of the blood vessel above baseline
    Description
    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
    Time Frame
    baseline, 24 and three months after the second extraction

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    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.

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    28759304
    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. Erratum In: J Dent Res. 2019 Jan;98(1):126-127.
    Results Reference
    derived

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    Acute Inflammation After Wisdom Tooth Removal

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