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Mechanisms and Treatment Response of Aggressive Periodontitis in Children

Primary Purpose

Aggressive Periodontitis

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Diseased periodontal treatment
Conventional periodontal treatment
Sponsored by
University of Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Aggressive Periodontitis focused on measuring Periodontitis

Eligibility Criteria

5 Years - 90 Years (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Acorn Dental Clinic
  • Broward College
  • Dental Clinical Research Unit, University of Florida
  • Azalea Dental Clinic
  • UF Hialeah Dental Clinic
  • Duval County Department of Health
  • UF Naples Pediatric Dental Clinic
  • Gadsden County Health Department--Quincy Dental Clinic
  • Leon County Health Department
  • University of Kentucky

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Diseased periodontal treatment

Conventional periodontal treatment

Arm Description

Scaling and root planing along with systemic antibiotics (Amoxicillin 500 mg and Metronidazole 250 mg tid 7 days).

Standard periodontal prophylaxis

Outcomes

Primary Outcome Measures

SNPs and DNA methylation
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

Systemic inflammatory levels
The investigators are testing for systemic (plasma levels) and local (gingival fluid levels) markers of inflammation.

Full Information

First Posted
April 4, 2011
Last Updated
July 6, 2022
Sponsor
University of Florida
Collaborators
National Institute of Dental and Craniofacial Research (NIDCR)
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1. Study Identification

Unique Protocol Identification Number
NCT01330719
Brief Title
Mechanisms and Treatment Response of Aggressive Periodontitis in Children
Official Title
Mechanisms and Treatment Response of Aggressive Periodontitis in Children: Aberrant Immunological Phenotypes/Functions in the Progression of AgP
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 2006 (Actual)
Primary Completion Date
May 29, 2019 (Actual)
Study Completion Date
December 2, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida
Collaborators
National Institute of Dental and Craniofacial Research (NIDCR)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aggressive Periodontitis
Keywords
Periodontitis

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
514 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Diseased periodontal treatment
Arm Type
Experimental
Arm Description
Scaling and root planing along with systemic antibiotics (Amoxicillin 500 mg and Metronidazole 250 mg tid 7 days).
Arm Title
Conventional periodontal treatment
Arm Type
Active Comparator
Arm Description
Standard periodontal prophylaxis
Intervention Type
Procedure
Intervention Name(s)
Diseased periodontal treatment
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Conventional periodontal treatment
Intervention Description
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.
Primary Outcome Measure Information:
Title
SNPs and DNA methylation
Description
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.
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Systemic inflammatory levels
Description
The investigators are testing for systemic (plasma levels) and local (gingival fluid levels) markers of inflammation.
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ikramuddin Aukhil
Organizational Affiliation
University of Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
Acorn Dental Clinic
City
Brooker
State/Province
Florida
ZIP/Postal Code
32622
Country
United States
Facility Name
Broward College
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33301
Country
United States
Facility Name
Dental Clinical Research Unit, University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Facility Name
Azalea Dental Clinic
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32640
Country
United States
Facility Name
UF Hialeah Dental Clinic
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33013
Country
United States
Facility Name
Duval County Department of Health
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32206
Country
United States
Facility Name
UF Naples Pediatric Dental Clinic
City
Naples
State/Province
Florida
ZIP/Postal Code
34113
Country
United States
Facility Name
Gadsden County Health Department--Quincy Dental Clinic
City
Quincy
State/Province
Florida
ZIP/Postal Code
32353
Country
United States
Facility Name
Leon County Health Department
City
Tallahassee
State/Province
Florida
ZIP/Postal Code
32310
Country
United States
Facility Name
University of Kentucky
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40506
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
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Mechanisms and Treatment Response of Aggressive Periodontitis in Children

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