Third Molar Clinical Trials: Pericoronitis Studies
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.
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||Pericoronitis; Oral and Systemic Inflammation|
- Quality of Life [ Time Frame: one year ] [ Designated as safety issue: No ]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
- inflammatory mediators [ Time Frame: one year ] [ Designated as safety issue: No ]
For enrolled patients with minor signs and symptoms of pericoronitis:
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.
- Assess the possible association between oral inflammation and systemic inflammation -Serum C-Reactive Protein and IL-6 levels at the time of active symptoms
Biospecimen Retention: Samples Without DNA
GCF samples. biofilm samples serum samples
|Study Start Date:||January 2008|
|Study Completion Date:||December 2013|
|Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
Those with mild signs/symptoms of pericoronitis affecting at least one lower 3rd molar with adjacent 2nd molar will be monitored for 12 months following study entry or 3 months for those electing to have 3rd molar extraction.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01882270
|United States, North Carolina|
|UNC School of Dentistry|
|Chapel Hill, North Carolina, United States, 27599-7450|
|Principal Investigator:||Ray White, DDS, PhD||University of North Carolina, Chapel Hill|