NCT03933514

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

Completed Last updated 3 May 2019

What this trial tests

trial testing Plaque control in Generalized Aggressive Periodontitis in 66 participants. Completed in 15 February 2017.

Timeline

1 April 2016

Primary endpoint
15 December 2016

15 February 2017

Quick facts

Lead sponsor	University of Campinas, Brazil
Status	Completed
Study type	OBSERVATIONAL
Enrollment	66
Start date	1 April 2016
Primary completion	15 December 2016
Estimated completion	15 February 2017

Drugs / interventions tested

• Plaque control

Conditions studied

• Generalized Aggressive Periodontitis — all drugs for Generalized Aggressive Periodontitis →

Sponsor

University of Campinas, Brazil

Who can join

6 and older, any sex, with Generalized Aggressive Periodontitis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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%.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Parents with periodontitis impact the subgingival colonization of their offspring.
   Monteiro MF, Altabtbaei K, Kumar PS, Casati MZ, et al · · 2021 · cited 23× · PMID 33446688 · DOI 10.1038/s41598-020-80372-4