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

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ClinicalTrials.gov Identifier: NCT03933514
Recruitment Status : Completed
First Posted : May 1, 2019
Last Update Posted : May 3, 2019
Sponsor:
Information provided by (Responsible Party):
Renato Casarin, University of Campinas, Brazil

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 Intervention/treatment
Generalized Aggressive Periodontitis Other: Plaque control

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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 1, 2016
Actual Primary Completion Date : December 15, 2016
Actual Study Completion Date : February 15, 2017

Group/Cohort Intervention/treatment
GAgP parents
Parents diagnosed with Generalized Aggressive Periodontitis
GAgP children
Children from parents diagnosed with Generalized Aggressive Periodontitis
Other: Plaque control
Children were instructed about the hygiene procedures

Health parents
Parents diagnosed as periodontally healthy
Health children
children from parents diagnosed as periodontally healthy
Other: Plaque control
Children were instructed about the hygiene procedures




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


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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.

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Responsible Party: Renato Casarin, Professor Dr., 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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Renato Casarin, University of Campinas, Brazil:
Family
Microbiome
Cytokines
Aggressive Periodontitis

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