Third Molar Clinical Trials: Pericoronitis Studies

NCT01882270 | Completed

• 1 other identifier: 05-2846
• Study Type: observational
• Target: 115
• Locations: 1 country
• Sites: 1

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.

Conditions

Pericoronitis

Keywords

pericoronitis; periodontal

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• inflammatory mediators

  one year

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead

Study Sites (1)

UNC School of Dentistry

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

Location

Related Publications (2)

• Golden BA, Baldwin C, Sherwood C, Abdelbaky O, Phillips C, Offenbacher S, White RP Jr. Monitoring for periodontal inflammatory disease in the third molar region. J Oral Maxillofac Surg. 2015 Apr;73(4):595-9. doi: 10.1016/j.joms.2014.10.010. Epub 2014 Oct 22.

  PMID: 25544296 DERIVED

• Magraw CB, Golden B, Phillips C, Tang DT, Munson J, Nelson BP, White RP Jr. Pain with pericoronitis affects quality of life. J Oral Maxillofac Surg. 2015 Jan;73(1):7-12. doi: 10.1016/j.joms.2014.06.458. Epub 2014 Jul 7.

  PMID: 25262404 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

GCF samples. biofilm samples serum samples

MeSH Terms

Conditions

Pericoronitis

Condition Hierarchy (Ancestors)

Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Ray White, DDS, PhD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2013
• First Posted: June 20, 2013
• Study Start: January 1, 2008
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: February 7, 2014

Record last verified: 2014-02

Locations

US (1)