Third Molar Clinical Trials: Pericoronitis Studies

Study Overview
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Brief Summary
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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
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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.

Official Title
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Pericoronitis; Oral and Systemic Inflammation

Conditions
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Pericoronitis

Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Mild Pericoronitis<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pericoronitis, periodontal