PericoronitisNCT01882270
Third Molar Clinical Trials: Pericoronitis Studies
An observational study of Pericoronitis, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Pericoronitis
- How many people
- 115 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2008to Dec 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- 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.
Who cannot join
- 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,
Show all 9Show fewer
- BMI > 29,
- Pregnancy,
- Non English speaking.
Trial locations and contacts
1 site in 1 country.
United States1 site
UNC School of Dentistry
Chapel Hill, North Carolina, 27599-7450
About this study
Official title: Pericoronitis; Oral and Systemic Inflammation
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.
Read the 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.
- Conditions
- Pericoronitis
- Keywords
- pericoronitis, periodontal
- Medical subject headings
- Pericoronitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: one year
Secondary outcomes (1)
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
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2013 (estimated)
- Study startJan 2008
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for PericoronitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ray White, DDS, PhD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01882270
- Sponsor's protocol ID
- 05-2846
- Status last verified
- Feb 2014
- First submitted
- 17 Jun 2013
- Last updated
- 7 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 25544296Magraw 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.
PubMed 25262404
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pericoronitis; Oral and Systemic Inflammation
- ClinicalTrials.gov ID
- NCT01882270
- Acronym / sponsor ID
- 05-2846
- Conditions
- Pericoronitis
- Keywords
- pericoronitis, periodontal
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 20 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (6 listed)
- 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,
Key exclusion criteria (9 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
inflammatory mediators
Time frame: one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2014.
- Derived from this study: PubMed 25544296Golden 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.
- Derived from this study: PubMed 25262404Magraw 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ray White, DDS, PhD principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pericoronitis, run by University of North Carolina, Chapel Hill at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Life (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01882270, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2014.