Clinical Trial: Third Molar Clinical Trials: Pericoronitis Studies

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Pericoronitis; Oral and Systemic Inflammation

Brief Summary: The purpose of this research study is to find out if the infection around 3rd molars and the resulting inflammation around the gum also produces a general systemic inflammation.

Detailed Summary: Relate signs and symptoms of mild pericoronitis, an oral clinical condition characterized by intense inflammation and pain around a lower 3rd molar, to indicators of oral and systemic inflammation in patients seeking treatment for the condition.
Sponsor: University of North Carolina, Chapel Hill

Current Primary Outcome: Quality of Life [ Time Frame: one year ]

HRQOL data each day for seven days: Subject diary Pain 7pt Likert scale for worst/average pain in past 24h Gracely Scales for current sensory perception/affect Lifestyle, oral function, other symptoms 5pt Likert type scale Global QOL OHIP 14


Original Primary Outcome: Same as current

Current Secondary Outcome: inflammatory mediators [ Time Frame: one year ]

For enrolled patients with minor signs and symptoms of pericoronitis:

  1. Assess oral inflammation

    • Levels of "orange/red complex" anaerobic bacteria in biofilm samples from distal of all 2nd molars and distal of affected 3rd molar.
    • Levels of GCF inflammatory mediators, PGE2 and IL-1ß from distal of all 2nd molars and mesial of 1st molars. If the first molar is absent, the mesial of the next most anterior tooth in the quadrant.
  2. Assess the possible association between oral inflammation and systemic inflammation -Serum C-Reactive Protein and IL-6 levels at the time of active symptoms


Original Secondary Outcome: Same as current

Information By: University of North Carolina, Chapel Hill

Dates:
Date Received: June 17, 2013
Date Started: January 2008
Date Completion:
Last Updated: February 6, 2014
Last Verified: February 2014