Third Molar Clinical Trials: Pericoronitis Studies

NCT ID: NCT01882270

Last Updated: 2014-02-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

115 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-01-31

Study Completion Date

2013-12-31

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.

Conditions

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Pericoronitis

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of North Carolina, Chapel Hill

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ray White, DDS, PhD

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Locations

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UNC School of Dentistry

Chapel Hill, North Carolina, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 25544296 (View on PubMed)

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.

Reference Type DERIVED
PMID: 25262404 (View on PubMed)

Other Identifiers

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05-2846

Identifier Type: -

Identifier Source: org_study_id

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