Third Molar Clinical Trials: Pericoronitis Studies

Completed

• Conditions: Pericoronitis

• Registration Number: NCT01882270
• Lead Sponsor: University of North Carolina, Chapel Hill

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 Description

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.

Study Timeline

• Study Start: 2008-01
• Study First Submitted: 2013-06-17
• Study First Submitted QC: 2013-06-17
• Study First Posted: 2013-06-20
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Status Verified: 2014-02
• Last Update Submitted: 2014-02-06
• Last Update Posted: 2014-02-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 115

Inclusion Criteria

• Mild signs/symptoms of pericoronitis affecting at least one lower 3rd molar with adjacent 2nd molar (spontaneous pain with localized swelling, purulence/drainage) with recommended treatment being removal of 3rd molars,
• Age 18 - 35 years,
• ASA I, II health status,
• AAP 1-3 periodontal status,
• Willingness to participate in the study,
• Geographic proximity to UNC.

Exclusion Criteria

• Major signs/symptoms of pericoronitis (Temperature >101 , dysphagia, limited mouth opening <20mm incisor, facial swelling/cellulitis, severe uncontrolled discomfort),
• ASA III, IV health status,
• Medical contraindication to full mouth periodontal probing,
• AAP 4 periodontal status,
• Antibiotic treatment within the past 2 months,
• Current tobacco use,
• BMI > 29,
• Pregnancy,
• Non English speaking.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Quality of Life	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

Secondary Outcome Measures

Name	Time	Method
inflammatory mediators	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

Trial Locations

Locations (1)

UNC School of Dentistry; 🇺🇸 Chapel Hill, North Carolina, United States