Mechanisms and Treatment Response of Aggressive Periodontitis in Children

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 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: June 12, 2014
Last verified: June 2014
  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 homogeneous population presenting similar aggressive disease characteristics to evaluate the mechanisms of this disease longitudinally. 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 conventional 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: Periodontal Treatment

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group 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

Further study details as provided by University of Florida:

Primary Outcome Measures:
  • Systemic Inflammatory Response [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    The investigators are testing for systemic (plasma levels) and local (gingival crevicular fluid levels) inflammatory responses using milliplex assay analysis.


Secondary Outcome Measures:
  • Oral Microbiota [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    The investigators are testing oral subgingival microbiota using Homin microarray analysis to detect ~300 bacterial species in aggressive periodontitis children compared to healthy siblings and unrelated controls.


Estimated Enrollment: 300
Study Start Date: December 2006
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Periodontal Treatment

Procedure/Surgery: Periodontal Treatment

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

Procedure: Periodontal Treatment
Conventional Periodontal treatment: Scaling and root planing along with systemic antibiotics (Amoxicillin 500 mg and Metronidazole 250 mg tid 7 days).

Detailed Description:

Aggressive periodontitis (AgP) is a group of rare, but severe, rapidly progressing form of periodontitis, characterized by an early age of onset and rapid bone destruction that leads to early tooth loss. It appears that this disease result from a combination of bacterial infection and hyperactivity of the immune system. However, given its rare occurrence and difficulties in gathering large populations, knowledge on specific mechanisms and consequently proper treatment of this disease remains based on case reports and a few small clinical trials.

The investigators have identified a cohort of at least fifty African-American children diagnosed within one clinical setting in Tallahassee, Florida, with a very similar pattern of localized AgP (LAgP). This group represents a small underserved population of north Florida. Our preliminary data shows an exacerbated immune response and specific groups of bacteria involved with this disease. With proper diagnostic tools and with the knowledge the investigators have already gained within this population, the investigators believe they are able to gather a larger population to further understand this aggressive disease and the effects conventional treatment has upon its mechanisms.

Therefore, the overall goal of this study is to determine which mechanisms are responsible for the rapid tissue destruction in children with aggressive periodontitis, and how conventional periodontal intervention affects these mechanisms. Our central hypothesis is that AgP is associated with a combination of a hyper-inflammatory innate trait and a specific group of bacteria and that periodontal therapy is able to modulate these parameters responsible for tissue destruction.

In order to test our hypothesis the investigators propose to: 1- To determine if 'traditional' periodontal treatment alters the hyper-responsive trait observed in LAgP by evaluating the systemic regulatory mechanisms of cyto/chemokine expression which contribute to tissue destruction; 2- To determine how local inflammatory mediators and metalloproteinases are modulated through the progression and treatment of periodontal disease in children with LAgP.; and 3- To determine alterations in subgingival microflora associated with LAgP after traditional periodontal treatment.

The investigators hope that the outcomes of this study will provide us with a better understanding of the mechanisms involved with aggressive periodontal tissue destruction in children and how treatment affects these mechanisms. This will enables us to investigate early and improved treatment approaches to prevent early tooth loss and possible future systemic complications.

  Eligibility

Ages Eligible for Study:   5 Years to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Subjects aged from 5-21 years old.
  2. Subjects diagnosed with localized aggressive periodontal disease or sibling, parents and grandparents of a subject diagnosed with this condition .
  3. Healthy (no periodontitis) subjects that are age, sex and race matched.
  4. African-Americans.

Exclusion Criteria:

  1. Subjects diagnosed with any systemic diseases or conditions that could influence the progression and/or clinical characteristics of periodontal disease (example- diabetics, subjects with blood disorders).
  2. Subjects that have taken antibiotics within the last 3 months.
  3. Subjects taking medications that could influence the characteristics or response to periodontal treatment (example-immune-suppressive drugs).
  4. Smokers (more than 10 cigarettes a day for over a year)
  5. Pregnant/lactating women.
  6. Disease subjects that are allergic to penicillin.
  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 lshaddox@dental.ufl.edu

Locations
United States, Florida
Dental Clinical Research Unit, University of Florida Recruiting
Gainesville, Florida, United States, 32610
Contact: Andrea Vovk, PhD    352-273-8364    avovk@dental.ufl.edu   
Contact: Nicole Ledger, BS    352-273-7911    nledger@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: Andrea Vovk, PhD    352-273-8364    avovk@dental.ufl.edu   
Principal Investigator: Luciana M Shaddox, DDS, MS, PhD         
Leon County Health Department Recruiting
Tallahassee, Florida, United States, 32310
Contact: Edward Zapert, DDS    850-606-8400    Ed-Zapert@doh.state.fl.us   
Contact: Andrea Vovk, PhD    352-273-8364    avovk@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: 505-2006, R01DE019456
Study First Received: April 4, 2011
Last Updated: June 12, 2014
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on July 20, 2014