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Gingivitis & Periodontal Disease Dental Study

The purpose of this study is to see how two specific proteins express themselves in the mouth when inflammation is induced. Understanding the proteins will help us understand the causes of periodontal disease. This may lead to new diagnose and treatment in the future.

Age & Gender

  • 18 years ~ 99 years
  • Male, Female

Visit Availability

  • Standard business hours (M-F, 8-5)

Location

North Carolina (Statewide)

What will be asked of you

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

Incentives

$200.00 (via Gift Card,) 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)

In-person visits : Up to 8
Total length of participation : up to 42 days

Looking for Specific Volunteers

Able to participate:

  • Have severe gum disease (periodonitis)
  • Otherwise in good general health
  • Able and willing to follow study procedures and instructions
  • Have at least 20 teeth, not including third molars
  • Have at least 3 natural teeth in a row in 2 areas of the mouth

Not eligible if:

  • Chronic illness that effects the mouth (including diabetes)
  • Current smoker or smoker within the last 2 years
  • Any other diseases of the mouth
  • New, regular medications started in the last 3 months

Looking for Healthy Volunteers

Requirements for healthy volunteers are different than for those with a specific condition. If you are interested in becoming a healthy volunteer for this study, use the below categories to determine if you are able to participate.

Able to participate:

  • Have generally healthy gums
  • In good general health
  • Able and willing to follow study procedures and instructions
  • Have at least 20 teeth, not including third molars
  • Have at least 3 natural teeth in a row in 2 areas of the mouth

Not eligible if:

  • Chronic illness that effects the mouth (including diabetes)
  • Current smoker or smoker within the last 2 years
  • Any other diseases of the mouth
  • New, regular medications started in the last 3 months
  • Chronic treatment with any medication known to affect periodontal status within one month of the screening examination

Contact the Team

Visit Location

100% Remote (online, phone, text)

Additional Study Information

Principal Investigator

Julie Marchesan
Periodontology

Study Type

Clinical or Medical
Interventional

Study Topics

Genetics and Genetic Disorders
Healthy Volunteer or General Population
Mouth and Teeth

IRB Number

18-0291

ClinicalTrials.gov

NCT03513497

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