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Periodontal (Gum) Disease Treatment Study

University of North Carolina at Chapel Hill


Description

To evaluate the safety and effectiveness of the Periodontal Structure Repair (PSR) procedure to assist with the treatment of periodontal pockets versus standard root planing (SRP).


Keywords:

Behavior, Men's Health, Mouth/Nose/Throat, Older Adults, Tooth/Dental, Women's Health


Category:

Medical Treatment Outcomes

Qualifications

 


Age
18 - 75 years


Gender
Any


Study Population

60 male and female subjects between the ages of 18-75 that have a history of periodontal disease (gum disease)


Investigator

Cristiano Susin
Clinical Professor, Department Chair
Periodontology

For questions, contact:

S.T. Phillips
gohealthcenter@unc.edu
(919) 537-3424
Visit Website

Recruitment Period End

October 29, 2019

Location

Primary Location
General and Oral Health Center, UNC SChool of Dentistry, 2040 First Dental Building
385 S Columbia St, Chapel Hill, NC 27599, USA

Study Qualifications

Gender Any

Age Range 18 - 75 years

Participant qualification(s) -Be in good general health -Have previously been diagnosed with gum disease (periodontal disease) -Have at least two teeth in at least two quadrants of the mouth Note: there are 4 quadrants in the mouth, top left and right, and bottom left and right

Not eligible if: -Must not have any significant health conditions including diabetes, impaired renal function, heart murmur, history of rheumatic fever or heart valve disease, or any bleeding disorder -Must not be pregnant or expect to become pregnant in the next several months - Must not wear braces -Must not take an antibiotic prior to dental treatment -Must not have had any periodontal procedures including root planning (deep cleaning) in the last 6 months. -Must have not received an investigational drug as part of a research study within the past 30 days -Must not be taking anticoagulant medications -Must not have tested positive for HIV, Hepatitis B, or Hepatitis C

Number of Visits

    » 16 study visits In person visit(s)

    Screening: member of the research team will ask questions about demographics (age, sex, race, etc), general health and medications. A urine sample will be collected, you will also be asked to provide a small amount of blood (approximately 3 teaspoons) to test for HIV, Hepatitis B, and Hepatitis C. Finally your gums will be evaluated for any signs of inflammation, redness, bleeding, infection, pain, swelling/edema, tooth mobility, and pocket (area between the tooth and gum) depth. Pre-Study Treatment procedures: Two weeks prior to the research treatment, you will receive a cleaning to remove plaque and tarter from above the gum line, similar to what you would receive when you go to the Dentist to have your teeth cleaned by a Dental Hygienist. You will also be trained to properly use oral hygiene products provided. Finally, you will be given instructions on how to keep a simple diary to record your oral hygiene for two weeks before the study treatment is provided. Study Treatment Visit: A research team member will check your vital signs (blood pressure, respiratory rate, and heart rate), your medical history/medication history will be updated, your teeth and gums will be re-evaluated, x-rays will be taken of the teeth that will receive study treatment. The teeth that meet study eligability (have pocket depths greater between 5-8mm) will be randomized (like flipping a coin) by a computer to receive either the PSR treatment, or root planning. You will be asked to return to the dental research office once a week for assessments during the 16 week post -study treatment period. Weeks 3, 5, 7, 9 and 11 visits will be decided by the study doctor and may not be required. If those visits are required, the study team will update medical history/medication list, record adverse events, and complete an oral hygiene assessment. At weeks 4,8,12, and 16, the study team will update medical history/medication list, complete vital signs a thorough oral assessment will be completed to include evaluation of any signs of inflammation, redness, bleeding on probing, infection, pain, swelling/edema, and tooth mobility. Visit 12 will include all study events listed previously, in addition to a urine sample being required to rule out pregnancy. A urinalysis will also be completed on the urine sample. You will be required to provide approximately three teaspoons of blood to show that there have not been any changes in the blood as a result of participating in this research study, X-rays will be taken again on teeth that received study treatment. Visit 16 will include all study procedures previously mentioned earlier, and you will be asked to provide approximately three teaspoons of blood to show that there have not been any changes in the blood as a result of participating in this research. You will also provide a urine sample for urinalysis.

    » 0 Remote visit(s)

Participation Period

20 weeks (5 months)

Compensation

$625

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.