Mechanisms and Treatment Response of Aggressive Periodontitis in Children

March 8, 2024 updated by: University of Florida

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

514

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Brooker, Florida, United States, 32622
        • Acorn Dental Clinic
      • Fort Lauderdale, Florida, United States, 33301
        • Broward College
      • Gainesville, Florida, United States, 32610
        • Dental Clinical Research Unit, University of Florida
      • Gainesville, Florida, United States, 32640
        • Azalea Dental Clinic
      • Hialeah, Florida, United States, 33013
        • UF Hialeah Dental Clinic
      • Jacksonville, Florida, United States, 32206
        • Duval County Department of Health
      • Naples, Florida, United States, 34113
        • UF Naples Pediatric Dental Clinic
      • Quincy, Florida, United States, 32353
        • Gadsden County Health Department--Quincy Dental Clinic
      • Tallahassee, Florida, United States, 32310
        • Leon County Health Department
    • Kentucky
      • Lexington, Kentucky, United States, 40506
        • University of Kentucky

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 90 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Diseased periodontal treatment
Scaling and root planing along with systemic antibiotics (Amoxicillin 500 mg and Metronidazole 250 mg tid 7 days).
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.
Active Comparator: Conventional periodontal treatment
Standard periodontal prophylaxis
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Systemic inflammatory levels
Time Frame: 24 months
The investigators are testing for systemic (plasma levels) and local (gingival fluid levels) markers of inflammation.
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Florida

Collaborators

National Institute of Dental and Craniofacial Research (NIDCR)

Investigators

  • Principal Investigator: Ikramuddin Aukhil, University of Florida

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2006

Primary Completion (Actual)

May 29, 2019

Study Completion (Actual)

December 2, 2022

Study Registration Dates

First Submitted

April 4, 2011

First Submitted That Met QC Criteria

April 5, 2011

First Posted (Estimated)

April 7, 2011

Study Record Updates

Last Update Posted (Actual)

March 12, 2024

Last Update Submitted That Met QC Criteria

March 8, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB201400349-N
  • R01DE019456 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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