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
• Sponsor: University of Campinas, Brazil
• Information provided by (Responsible Party): Renato Casarin, University of Campinas, Brazil

Tracking Information

• First Submitted Date: April 29, 2019
• First Posted Date: May 1, 2019
• Last Update Posted Date: May 3, 2019
• Actual Study Start Date: April 1, 2016
• Actual Primary Completion Date: December 15, 2016 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 29, 2019)

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.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: May 1, 2019)

• 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
• 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
• Change in the microbial composition at 3 months [ Time Frame: Baseline and 45 days for each test ]
  Concentration of bacteria in the subgingival biofilm

Original Secondary Outcome Measures (submitted: April 29, 2019)

• Change of the baseline bledding 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
• 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
• Change in the microbial composition at 3 months [ Time Frame: Baseline and 45 days for each test ]
  Concentration of bacteria in the subgingival biofilm

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Metagenomic and Immune-inflammatory Analysis of Individuals With Generalized Aggressive Periodontitis and Their Descendants.
• Official Title: Metagenomic and Immune-inflammatory Analysis of Individuals With Generalized Aggressive Periodontitis and Their Descendants.
• 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%.
• Detailed Description: Not Provided
• Study Type: Observational
• Study Design: Observational Model: Case-Control; Time Perspective: Other
• Target Follow-Up Duration: Not Provided

Biospecimen

Retention:   Samples With DNA

Description:

Dental Biofilm

• Sampling Method: Non-Probability Sample
• Study Population: The population selected from Piracicaba Dental School graduation clinic
• Condition: Generalized Aggressive Periodontitis

Intervention

Other: Plaque control

Children were instructed about the hygiene procedures

Study Groups/Cohorts

• GAgP parents
  Parents diagnosed with Generalized Aggressive Periodontitis
• GAgP children
  Children from parents diagnosed with Generalized Aggressive Periodontitis
  Intervention: Other: Plaque control
• Health parents
  Parents diagnosed as periodontally healthy
• Health children
  children from parents diagnosed as periodontally healthy
  Intervention: Other: Plaque control

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: April 29, 2019): 66
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: February 15, 2017
• Actual Primary Completion Date: December 15, 2016 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 6 Years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT03933514
• Other Study ID Numbers: 079/2013
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

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

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Responsible Party: Renato Casarin, University of Campinas, Brazil
• Study Sponsor: University of Campinas, Brazil
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: University of Campinas, Brazil
• Verification Date: May 2019