Mechanisms and Treatment Response of Aggressive Periodontitis in Children

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2015 by University of Florida
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT01330719
First received: April 4, 2011
Last updated: April 6, 2015
Last verified: April 2015
  Purpose

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.


Condition Intervention
Aggressive Periodontitis
Procedure: Diseased periodontal treatment
Procedure: Conventional periodontal treatment

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by University of Florida:

Primary Outcome Measures:
  • SNPs and DNA methylation [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    The investigators are testing for systemic (plasma levels) and local (gingival fluid levels) markers of inflammation.


Estimated Enrollment: 960
Study Start Date: December 2006
Estimated Study Completion Date: May 2019
Estimated Primary Completion Date: May 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   5 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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

Eclusion 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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01330719

Contacts
Contact: Luciana M Shaddox, PHD; DDS 352-273-8368 ShaddoxResearch@dental.ufl.edu

Locations
United States, Florida
Acorn Dental Clinic Recruiting
Brooker, Florida, United States, 32622
Contact: Laurie Jennings    352-485-1133    ljennings@acornclinic.org   
Contact: Tina Treloar, RDH, BAS    352-273-8364    ShaddoxResearch@dental.ufl.edu   
Azalea Dental Clinic Recruiting
Gainesville, Florida, United States, 32640
Contact: Brandon Greenwalt, DMD    352-375-3790    blgreenwalt@gmail.com   
Contact: Tina Treloar, RDH, BAS    352-273-8364    ShaddoxResearch@dental.ufl.edu   
Dental Clinical Research Unit, University of Florida Recruiting
Gainesville, Florida, United States, 32610
Contact: Tina C Treloar, RDH, BAS    352-273-8364    ShaddoxResearch@dental.ufl.edu   
Contact: Sandra Stuhr, BA    352-273-7911    ShaddoxResearch@dental.ufl.edu   
Principal Investigator: Luciana Shaddox, DDS, MS, PhD         
Duval County Department of Health Recruiting
Jacksonville, Florida, United States, 32206
Contact: Phillis Varnado, DDS    904-253-1210    Phillis_Varnado@doh.state.fl.us   
Contact: Tina C Treloar, RDH, BAS    352-273-8364    ShaddoxResearch@dental.ufl.edu   
Principal Investigator: Luciana M Shaddox, DDS, MS, PhD         
UF Naples Pediatric Dental Clinic Recruiting
Naples, Florida, United States, 34113
Contact: Kelly Magher, DMD    239-775-3052    kmagher@dental.ufl.edu   
Contact: Tina Treloar, RDH, BAS    352-273-8364    ShaddoxResearch@dental.ufl.edu   
Gadsden County Health Department Recruiting
Quincy, Florida, United States, 32353
Contact: Laura Villegas-Lopez    850-875-7200    Laura.Villegas@flhealth.gov   
Contact: Tina Treloar, RDH, BAS    352-273-8364    ShaddoxResearch@dental.ufl.edu   
Leon County Health Department Recruiting
Tallahassee, Florida, United States, 32310
Contact: Edward Zapert, DDS    850-606-8400    Ed-Zapert@doh.state.fl.us   
Contact: Tina C Treloar, RDH, BAS    352-273-8364    ShaddoxResearch@dental.ufl.edu   
Principal Investigator: Luciana M Shaddox, DDS, MS, PhD         
Sponsors and Collaborators
University of Florida
Investigators
Principal Investigator: Luciana M Shaddox, DDS University of Florida
  More Information

Publications:

Additional 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: IRB2001400349, R01DE019456
Study First Received: April 4, 2011
Last Updated: April 6, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by University of Florida:
Periodontitis

Additional relevant MeSH terms:
Aggression
Aggressive Periodontitis
Periodontitis
Behavioral Symptoms
Mouth Diseases
Periodontal Diseases
Stomatognathic Diseases

ClinicalTrials.gov processed this record on April 23, 2015