Third Molar Clinical Trials: Pericoronitis Studies

Pericoronitis Clinical Trial

Official title:

Pericoronitis; Oral and Systemic Inflammation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01882270
• Other study ID #: 05-2846
• Status: Completed
• Phase: N/A
• First received: June 17, 2013
• Last updated: February 6, 2014
• Start date: January 2008
• Est. completion date: December 2013

Study information

• Verified date: February 2014
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 115
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 35 Years

Eligibility

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

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Pericoronitis

Locations

Country	Name	City	State
United States	UNC School of Dentistry	Chapel Hill	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of Life	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	one year	No
Secondary	inflammatory mediators	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	one year	No