Mechanisms and Treatment Response of Aggressive Periodontitis in Children
- Conditions
- Aggressive Periodontitis
- Interventions
- Procedure: Conventional periodontal treatmentProcedure: Diseased periodontal treatment
- Registration Number
- NCT01330719
- Lead Sponsor
- University of Florida
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 514
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Conventional periodontal treatment Conventional periodontal treatment Standard periodontal prophylaxis Diseased periodontal treatment Diseased periodontal treatment Scaling and root planing along with systemic antibiotics (Amoxicillin 500 mg and Metronidazole 250 mg tid 7 days).
- Primary Outcome Measures
Name Time Method SNPs and DNA methylation 24 months The investigators are doing analysis of single nucleotide polymorphisms (DNA sequence variation) and methylation (addition of a methyl group) of DNA of specific genes related to inflammation.
- Secondary Outcome Measures
Name Time Method Systemic inflammatory levels 24 months The investigators are testing for systemic (plasma levels) and local (gingival fluid levels) markers of inflammation.
Trial Locations
- Locations (10)
Acorn Dental Clinic
🇺🇸Brooker, Florida, United States
Broward College
🇺🇸Fort Lauderdale, Florida, United States
Leon County Health Department
🇺🇸Tallahassee, Florida, United States
Azalea Dental Clinic
🇺🇸Gainesville, Florida, United States
UF Hialeah Dental Clinic
🇺🇸Hialeah, Florida, United States
UF Naples Pediatric Dental Clinic
🇺🇸Naples, Florida, United States
Gadsden County Health Department--Quincy Dental Clinic
🇺🇸Quincy, Florida, United States
Duval County Department of Health
🇺🇸Jacksonville, Florida, United States
Dental Clinical Research Unit, University of Florida
🇺🇸Gainesville, Florida, United States
University of Kentucky
🇺🇸Lexington, Kentucky, United States