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Third Molar Clinical Trials: Pericoronitis Studies

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT01882270
First received: June 17, 2013
Last updated: February 6, 2014
Last verified: February 2014
  Purpose

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.


Condition
Pericoronitis

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Pericoronitis; Oral and Systemic Inflammation

Further study details as provided by University of North Carolina, Chapel Hill:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • inflammatory mediators [ Time Frame: one year ] [ Designated as safety issue: No ]

    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


Biospecimen Retention:   Samples Without DNA

GCF samples. biofilm samples serum samples


Enrollment: 115
Study Start Date: January 2008
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Mild Pericoronitis
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Those with mild signs/symptoms of pericoronitis affecting at least one lower 3rd molar with adjacent 2nd molar with recommended treatment being removal of 3rd molars.

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01882270

Locations
United States, North Carolina
UNC School of Dentistry
Chapel Hill, North Carolina, United States, 27599-7450
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Investigators
Principal Investigator: Ray White, DDS, PhD University of North Carolina, Chapel Hill
  More Information

No publications provided

Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT01882270     History of Changes
Other Study ID Numbers: 05-2846
Study First Received: June 17, 2013
Last Updated: February 6, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of North Carolina, Chapel Hill:
pericoronitis
periodontal

Additional relevant MeSH terms:
Pericoronitis
Gingival Diseases
Mouth Diseases
Periodontal Diseases
Stomatognathic Diseases

ClinicalTrials.gov processed this record on November 25, 2014