Skip to main content
OpenTrials
Completed

NCT Number: NCT01882270

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Pericoronitis Gingival Diseases Mouth Diseases Periodontal Diseases Stomatognathic Diseases

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Observational

Primary location

UNC School of Dentistry

Chapel Hill, North Carolina, 27599-7450, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Registry information

Official study title

Pericoronitis; Oral and Systemic Inflammation

Important dates

Study start
2008
Primary completion
2013
Study completion
2013
First posted
Jun 20, 2013
Registry last updated
Feb 7, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.