Mechanisms and Treatment Response of Aggressive Periodontitis in Children



Status:Active, not recruiting
Conditions:Psychiatric, Dental
Therapuetic Areas:Dental / Maxillofacial Surgery, Psychiatry / Psychology
Healthy:No
Age Range:5 - 90
Updated:12/1/2018
Start Date:December 2006
End Date:December 2019

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Mechanisms and Treatment Response of Aggressive Periodontitis in Children: Aberrant Immunological Phenotypes/Functions in the Progression of AgP

Although of low prevalence, aggressive periodontitis is a rapid destructive form of
periodontal disease that initiates at a young age, leading to premature loss of first molars
and incisors. Little is known on the mechanisms of this disease. It is imperative to
understand mechanisms of disease to establish proper treatment. We have established a
controlled study in a comparable population presenting similar aggressive disease
characteristics to evaluate the mechanisms of this disease. It is the goal of this study to
determine immunological and microbiological mechanisms responsible for the rapid tissue
destruction in children with localized aggressive periodontitis and how traditional
periodontal intervention affects these mechanisms. Important knowledge gained with this
proposal will aid in defining specific treatment approaches to better control disease
progression and prevent disease initiation in susceptible individuals.

There a multiple appointments throughout the study which can vary depending upon if a patient
has the disease present or not.

If the patient has gum disease: At the initial examination, some samples will be collected:
the natural fluid that comes from the gums and the bacteria that are present there will be
collected by inserting a piece of paper and a filter strip in the spaces between teeth and
gums; blood samples may also be taken by a phlebotomist to evaluate some inflammatory signs
of disease and possible genetic markers (about 5 teaspoons at each visit); and a cheek swab
may be taken by gently rubbing a little brush into the inside of the cheeks. Patients also
may be asked to spit into a container we provide. Tissues from gums that are usually
discarded may also be collected during treatment. When patients return for re-evaluation of
their gums, all these samples may be collected again at 3, 6, 12, 18 and 24 months after the
initial therapy. After 24 months, only clinical examinations may be performed, up to 3 more
visits within the following 3 years.

If the patient does not have gum disease: If gums are healthy and the patient does not need
treatment, they will be seen every 6 months for examination and cleanings, then sample
collections may also be taken at these visits up to 24 months. These sample collections are
done to be studied by genetic tests, which will tell us if there are specific genetic markers
(inherited markers) associated with this disease, and also other laboratory testing, which
will help the researchers identify how the body responds to bacteria. These markers will also
be evaluated in family members (parents, grandparents or siblings), when possible, to check
for the likelihood of these members developing this disease.

Regardless of the patient's gum condition, investigators will also evaluate current and past
dental x-rays to determine if there were signs of this disease in the past.

Investigators may also take photos of the teeth and gums.

Inclusion child/adolescent:

- Male or female, aged 5 to 25

- In good general health as evidenced by medical history

- Diagnosed with localized aggressive periodontitis (LAP), defined by the presence of
attachment loss ≥ 2mm and detected bone loss on at least two sites, involving first
molars and/or incisors, or

- Periodontally healthy (defined by absence of clinical signs of periodontitis) related
or not to LAP participants

Inclusion parent /grandparent:

- Male or female, up to age 90 years

- Parent or grandparent of an enrolled participant with LAP

Exclusion child/adolescent:

- Diagnosed with any systemic diseases or conditions that could influence the
progression and/or clinical characteristics of periodontal disease (i.e.,
immunosuppression, diabetes, neutropenia or blood disorders).

- Patients that have taken antibiotics within the last 3 months* or require antibiotic
prophylaxis prior to initial visit.

- Patients that are currently taking medications that could influence the
characteristics or response to periodontal treatment (example: immune-suppressive
drugs, such as cyclosporine or steroids).

- Smokers (≥10 cigarettes a day for over 6 months)

- Pregnant/lactating women as pregnancy causes gingival changes that could confound
study results.

- Any psychiatric conditions that will inhibit participants from proper understanding of
study procedures as determined by the PI/clinician investigator.

- patients may still enroll but will be scheduled for initial visit 3 months later

Exclusion parent/grandparent:

- Patients that have taken antibiotics within the last 3 months* or require antibiotic
prophylaxis prior to initial visit.

- Pregnant/lactating women as pregnancy causes gingival changes that could confound
study results.

- Any psychiatric conditions that will inhibit participants from proper understanding of
study procedures as determined by the PI/clinician investigator.
We found this trial at
10
sites
Gainesville, Florida 32640
Phone: 352-375-3790
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Brooker, Florida 32622
Phone: 352-485-1133
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Fort Lauderdale, Florida 33301
Phone: 954-201-6904
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Gainesville, Florida 32610
Principal Investigator: Luciana Shaddox, DDS, MS, PhD
Phone: 352-273-7911
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750 East 25th Street
Hialeah, Florida 33013
Phone: 305-694-5400
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Jacksonville, Florida 32206
Principal Investigator: Luciana M Shaddox, DDS, MS, PhD
Phone: 904-253-1210
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Lexington, Kentucky
859) 257-9000
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Naples, Florida 34113
Phone: 239-775-3052
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Quincy, Florida 32353
Phone: 352-273-8364
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Tallahassee, Florida 32310
Principal Investigator: Luciana M Shaddox, DDS, MS, PhD
Phone: 850-606-8400
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Tallahassee, FL
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