Third Molar Clinical Trials: Pericoronitis Studies
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01882270|
Recruitment Status : Completed
First Posted : June 20, 2013
Last Update Posted : February 7, 2014
|Condition or disease|
|Study Type :||Observational|
|Actual Enrollment :||115 participants|
|Official Title:||Pericoronitis; Oral and Systemic Inflammation|
|Study Start Date :||January 2008|
|Actual Primary Completion Date :||December 2013|
|Actual Study Completion Date :||December 2013|
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.
- 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
- inflammatory mediators [ Time Frame: one year ]
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|