Mechanisms and Treatment Response of Aggressive Periodontitis in Children
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| ClinicalTrials.gov Identifier: NCT01330719 |
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Recruitment Status :
Active, not recruiting
First Posted : April 7, 2011
Last Update Posted : December 13, 2019
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Aggressive Periodontitis | Procedure: Diseased periodontal treatment Procedure: Conventional periodontal treatment | Not Applicable |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 514 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Prevention |
| Official Title: | Mechanisms and Treatment Response of Aggressive Periodontitis in Children: Aberrant Immunological Phenotypes/Functions in the Progression of AgP |
| Actual Study Start Date : | December 2006 |
| Actual Primary Completion Date : | May 29, 2019 |
| Estimated Study Completion Date : | May 29, 2020 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Diseased periodontal treatment
Scaling and root planing along with systemic antibiotics (Amoxicillin 500 mg and Metronidazole 250 mg tid 7 days).
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Procedure: Diseased periodontal treatment
Treatment includes scaling and root planing with systemic antibiotics, Amoxicillin 500 mg and Metronidazole 250 mg tid 7 days. At certain intervals after the scaling and root planing, your gums will be reevaluated. You will receive further surgical gum therapy only if your gums haven't shown improvement after first treatment on the reevaluation appointments. If surgery is needed, a bone substituting material may be necessary to "fill" the spaces where bone has been destroyed by the disease. Extraction of teeth might also be part of gum treatment if the disease is very severe. Re-treatment with antibiotics also may be necessary depending on the response after treatment. You are usually re-examined and receive additional cleanings every 3 to 6 months to ensure the disease does not come back. |
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Active Comparator: Conventional periodontal treatment
Standard periodontal prophylaxis
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Procedure: Conventional periodontal treatment
Scaling and gum measurement will be taken to compare to the treated group.- If it is determined that you do not have this disease, a conventional cleaning is done, usually every 6 months. This is all part of normal clinical care. |
- SNPs and DNA methylation [ Time Frame: 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.
- Systemic inflammatory levels [ Time Frame: 24 months ]The investigators are testing for systemic (plasma levels) and local (gingival fluid levels) markers of inflammation.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 5 Years to 90 Years (Child, Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
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.
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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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01330719
| United States, Florida | |
| Acorn Dental Clinic | |
| Brooker, Florida, United States, 32622 | |
| Broward College | |
| Fort Lauderdale, Florida, United States, 33301 | |
| Dental Clinical Research Unit, University of Florida | |
| Gainesville, Florida, United States, 32610 | |
| Azalea Dental Clinic | |
| Gainesville, Florida, United States, 32640 | |
| UF Hialeah Dental Clinic | |
| Hialeah, Florida, United States, 33013 | |
| Duval County Department of Health | |
| Jacksonville, Florida, United States, 32206 | |
| UF Naples Pediatric Dental Clinic | |
| Naples, Florida, United States, 34113 | |
| Gadsden County Health Department--Quincy Dental Clinic | |
| Quincy, Florida, United States, 32353 | |
| Leon County Health Department | |
| Tallahassee, Florida, United States, 32310 | |
| United States, Kentucky | |
| University of Kentucky | |
| Lexington, Kentucky, United States, 40506 | |
| Principal Investigator: | Ikramuddin Aukhil | University of Florida |
Publications of Results:
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | University of Florida |
| ClinicalTrials.gov Identifier: | NCT01330719 History of Changes |
| Other Study ID Numbers: |
IRB201400349-N R01DE019456 ( U.S. NIH Grant/Contract ) |
| First Posted: | April 7, 2011 Key Record Dates |
| Last Update Posted: | December 13, 2019 |
| Last Verified: | December 2019 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Periodontitis |
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Periodontitis Aggressive Periodontitis Aggression Periodontal Diseases |
Mouth Diseases Stomatognathic Diseases Behavioral Symptoms |