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Metagenomic and Immune-inflammatory Analysis of Individuals With Generalized Aggressive Periodontitis and Their Descendants.

  • Clinicaltrials.gov identifier

    NCT03933514

  • Recruitment Status

    Completed

  • First Posted

    May 1, 2019

  • Last update posted

    May 3, 2019

Study Description

Brief summary:

Generalized aggressive periodontitis (GAgP) is a multifactorial disease related to several aspects that influence its installation and progression. A constant microbial colonization, an altered inflammatory response, and a clear genetic factor are cited as possible factors associated with this pathology. Thus, aggressive periodontitis subjects could transmit for their descendants some genetical alterations, such as inflammatory response pattern associated with periodontal destruction and susceptibility to colonization by some pathogens, increasing the risk of develops this disease. This way, this project is aimed to evaluate the pattern of microbiological colonization and the inflammatory response pattern associated with it, comparing parents with generalized aggressive periodontitis and their children and periodontally healthy parents and their children. Thirty families will be selected and divided into two groups: Test group (n=15 families) families in which the parents (or at least one of them) present generalized aggressive periodontitis and one child (age ranging from 6-12 years old); Control group (n=15 families) families in which the parents (both of them) present periodontal healthy and one child (age ranging from 6-12 years old). The groups will be composed using a gender- and age-matched structure. The children will participate in a hygiene program and will be monitored for 3 months. All individuals (parents and children) will be clinically assessed for plaque and bleeding index, periodontal probing depth, clinical attachment level and gingival recession. During this period, samples of gingival crevicular fluid (GCF) and subgingival biofilm from periodontal pockets/sites from all subject (parents and children) will be collected. The GCF will be analyzed and the detection of interleukin (IL)-1β, IL-4, IL-6, IL-8, IL-10, IL-17, tumor necrosis factor (TNF)-α, and interferon (INF)-γ will be done using Luminex/MAGpix technology. In a subgingival biofilm, the DNA will be extracted and the microbiome and its functional characteristics will be evaluated by metagenomics and bioinformatics analysis. The data will be compared by Student's t-test, Mann-Whitney e Wilcoxon tests. The significance level for all analysis will be 5%.

  • Condition or Disease:Generalized Aggressive Periodontitis
  • Intervention/Treatment: Other: Plaque control
  • Phase: N/A

Detailed Description

N/A

Study Design

  • Study Type: Observational
  • Actual Enrollment: 66 participants
  • Observational Model: Case-Control
  • Time Perspective: Other
  • Official Title: Metagenomic and Immune-inflammatory Analysis of Individuals With Generalized Aggressive Periodontitis and Their Descendants.
  • Actual Study Start Date: April 2016
  • Actual Primary Completion Date: December 2016
  • Actual Study Completion Date: February 2017

Groups and Cohorts

Groups/Cohorts Intervention/treatment
: GAgP children
Children from parents diagnosed with Generalized Aggressive Periodontitis
Other: Plaque control
Children were instructed about the hygiene procedures
: Health children
children from parents diagnosed as periodontally healthy
Other: Plaque control
Children were instructed about the hygiene procedures

Outcome Measures

  • Primary Outcome Measures: 1. Change of the baseline plaque index on probing at 3 months [ Time Frame: Baseline and 3 months for each test ]
    Reduction in the amount of plaque accumulation around the gingival marginal after the therapy.
  • Secondary Outcome Measures: 1. Change of the baseline bleeding on probing at 3 months [ Time Frame: Baseline and 3 months for each test ]
    Bleeding induced at the depth of the gingival sulcus or periodontal pocket after probing
  • 2. Change of the baseline inflammatory markers levels in gingival crevicular fluid (pg/uL) at 3 months [ Time Frame: Baseline and 3 months for each test ]
    Concentration of IL-1β, IL-4, IL-6, IL-8, IL-10, IL-17, TNF-α and INF-γ released in gingival crevicular fluid
  • 3. Change in the microbial composition at 3 months [ Time Frame: Baseline and 45 days for each test ]
    Concentration of bacteria in the subgingival biofilm
  • Biospecimen Retention: Samples With DNA

    Dental Biofilm

Eligibility Criteria

  • Ages Eligible for Study: 6 Years and older (Child, Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: Yes
  • Sampling Method: Non-Probability Sample
  • Study Population: The population selected from Piracicaba Dental School graduation clinic

Criteria

Inclusion Criteria:

- GAgP parents: i) less than 35 years old at the diagnosis; ii) at least 8 teeth with
probing depth (PD) and clinical attachment level (CAL) > 5mm (with at least 2 sites
with PD > 7mm) at diagnosis; iii) at least 20 teeth in the oral cavity; iv) good
systemic health.

- Health parents: i) Good systemic health; ii) at least 20 teeth in the oral cavity;
iii) absence of periodontal pockets/gingival sulcus with PD > 4mm; iv) absence of
proximal bone loss.

- Children: i) to present parents respecting the inclusion criteria for periodontal
health or GAgP; ii) 6 to 12 years of age at the beginning of study iii) good systemic
health iv) presence of first molars and central incisors.

Exclusion Criteria

- the use of antibiotics and anti-inflammatory medication 6 months prior to the study;

- smoking habits

- pregnancy or lactation.

Contacts and Locations

Contacts

Locations

Sponsors and Collaborators

University of Campinas, Brazil

More Information

  • Responsible Party: University of Campinas, Brazil
  • ClinicalTrials.gov Identifier: NCT03933514 History of Changes
  • Other Study ID Numbers: 079/2013
  • First Posted: May 1, 2019 Key Record Dates
  • Last Update Posted: May 3, 2019
  • Last Verified: May 2019
  • Individual Participant
    Data (IPD) Sharing
    Statement:

  • Plan to Share IPD: Undecided
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by University of Campinas, Brazil: Family
    Microbiome
    Cytokines
    Aggressive Periodontitis
  • Additional relevant MeSH terms: Periodontitis
    Aggressive Periodontitis
    Aggression