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(IFI)16 is a Periodontitis Modulating Protein

University of North Carolina at Chapel Hill


Description

The purpose of this study is to evaluate how two specific proteins express themselves in the mouth when inflammation is induced. Understanding the expression of the proteins will help give insight to the underlying causes of periodontal disease. Ultimately this discovery may lead to new and improved ways to diagnose and treat periodontal disease in the future.


Keywords:

Genetics, Men's Health, Microbiome, Mouth/Nose/Throat, Tooth/Dental, Women's Health


Category:

Procedures

Qualifications

 


Age
18 - 99 years


Gender
Any


Study Population

72 subjects (age 18+) will be recruited (36 considered periodontially healthy and 36 considered periodontally diseased. Subjects must not smoke, and be in good general health with at least 20 teeth


Investigator

Julie Marchesan
Assistant Professor
Periodontology

For questions, contact:

Kristy Williams
gohealthcenter@unc.edu
(919) 537-3424
Visit Website

Recruitment Period End

February 5, 2020

Location

Primary Location
UNC School of Dentistry-Go Health Center
385 S Columbia St, Chapel Hill, NC 27599, USA
Secondary Location
Go Health Center
Old Dental Building, 150 Dental Cir Room 2040, Chapel Hill, NC 27514, USA

Study Qualifications

Gender Any

Age Range 18 - 99 years

Participant qualification(s) · Subjects must have read, understood and signed an informed consent form in English. ·Subjects must be able and willing to follow study procedures and instructions in English. ·Subjects must be adult males or females with a minimum of 18 years (inclusive). ·Subjects must present with at least 20 teeth in the functional dentition, excluding third molars. ·subjects must have at least 3 teeth in each posterior sextant · subjects must be in good general health · Subjects must be in the healthy (PPC-A) or severe periodontitis (PPC-G) categories according to the PPC (specific dental category assigning tool)

Not eligible if: - If the sextants identified for the analysis has implants -subjects requiring antibiotics prior to dental treatment -Chronic disease with oral manifestations including diabetes mellitus. - Current smoker or one that has stopped smoking less than 2 years prior to enrollment. -Gross oral pathology other than the periodontal disease ( (Severe unrestored caries, or any condition that is likely to require antibiotic treatment over the course of the study) -Treatment with antibiotics for any medical or dental condition within 1 month prior to the screening examination. -Chronic treatment (i.e., two weeks or more) with any medication known to affect periodontal status (e.g., phenytoin, calcium antagonists, cyclosporin, coumadin, non-steroidal anti-inflammatory drugs, aspirin) within one month of the screening examination. -Ongoing medications initiated less than three months prior to enrollment (i.e., medications for chronic medical conditions must be initiated at least three months prior to enrollment). - Significant organ disease including impaired renal function, heart murmur, history of rheumatic fever or valvular disease, or any bleeding disorder. - Individuals with prosthetic material used for intra-cardiac repair (e.g. for congenital heart disease), or intra-cardiac devices, cardiac transplant, infective endocarditis and individuals who have had previous infectious complications of prosthetic joint infections -Infectious diseases such as hepatitis, HIV or tuberculosis. -Anemia or other blood dyscrasias. -Anticoagulant therapy or drugs, such as heparin or warfarin. -Pregnant, or expect to become pregnant within the next several months. Note: Females of child-bearing capacity must be willing to have pregnancy test to confirm they are not pregnant. - Females of child-bearing capacity not using any form of contraceptive methods -Anything that would place the individual at increased risk or preclude the individual's full compliance with or completion of the study.

Number of Visits

    » Up to 8 In person visit(s)

    Visit 1 (Day -14, +/- 2 days) will screen/ confirm eligibility of subject. Eligibility will be determined based on medical hx and clinical measures. If subject is deemed eligible, they will be invited to participate in the study, have impressions taken for stent (mouth guard) fabrication. Visit 2: (Day 0; +/2 2 days) Medical hx will be updated, subject will have clinical measures evaluated (to include plaque index, gingival index, bleeding on probing, and clinical attachment level),will have the stent delivered with instructions on use. Lastly, subject will have a biopsy sample completed on selected tissue (identified at visit 1). Visit 3 (Day 7 +/-2 days) and Visit 4 (Day 14 +/-2 days): medical hx will be updated, subject will have clinical measures evaluated, and a biopsy follow up will be conducted to verify proper healing. Visit 5 (Day 21; +/-2 days) Medical hx updated, subject will have clinical measures evaluated, and instructed to discontinue use of stent. A biopsy sample will be completed. If the subject is identified in the severe periodontal classification group, Scaling Root Planing (SRP/deep cleaning) will be initiated at this visit. Visit 6: final Visit (Day 28; +/-2 days), Medical hx updated, subject will have clinical measures evaluated, and a biopsy follow up will occur to verify proper healing. Scaling Root planing (SRP) will continue for subjects identified in the severe periodontally diseased group. An adult prophylaxis (cleaning) will be provided to individuals in the healthy group. Visit 7 Day 35 (+/-2 days) (if needed for continuation of SRP), medical hx updated, SRP continued Visit 8 Day 42 (+/-2 days) (if needed for completion of SRP), medical hx updated, SRP continued

    » 0 Remote visit(s)

Participation Period

up to 42 days

Compensation

$200.00 (via Check,) at the conclusion of the study (Visit 6) Adult Prophylasis (cleaning; for subjects deemed peridontally healthy), or Scaling and Root Planing (Deep Cleaning) for subjects categorized as having periodontal disease, and free parking vouchers (at each visit) to the visitor's parking deck (Dogwood)

By clicking I am interested, your contact information will be sent to the researcher/study coordinator for this study. The coordinator will respond by email with additional information on how to proceed.