DNA Methylation Profile of the SOCS-1 Gene Promoter in Smokers Patients With Chronic Periodontitis.

NCT03371446 | Completed DMC

• 1 other identifier: CAAE: 57171816.2.0000.5419
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Periodontitis is related to host genetics, constitution of the dental biofilm and environmental factors such as smoking. DNA methylation is a mechanism of genetic expression that can inhibit or silence gene expression. In this way several researchers have been dedicated to study the genetic influence on the susceptibility and / or increased risk to periodontal disease. Studies have reported association between several epigenetic biomarkers with periodontal inflammation. Considering the hypothesis that there is an association between smoking and methylation in genes related to periodontal disease, the objective of this study was to verify the DNA methylation pattern in oral epithelial cells of patients with chronic periodontitis (CP) in the promoter of a specific gene involved in the control of inflammation, as suppressor of cytokine signaling (SOCS) 1 in smokers and nonsmokers patients.

Conditions

Periodontal Diseases; Epigenetics

Keywords

DNA Methylation. Smoking. SOCS-1 gene.

Outcome Measures

Primary Outcomes (1)

• Extraction of genomic DNA from oral epithelial cells

  Epithelial cells were collected after mouthwash with 5ml dextrose autoclaved 3% and stored under refrigeration at -20ºC. After collection, the samples were taken to the Epigenetics and Reproduction Laboratory of the Department of Genetics of the Medical School of Ribeirão Preto-USP (FMRP-USP) where nucleic acid extraction and molecular analysis were performed. After thawing the saliva, 2ml of each sample collected were transferred separately to eppendorf tubes, for processing. The material was then diluted in 50 μl of cobalt Mili-Q water, incubated at 37 ° C in a water bath for 1 hour and stored in a freezer at -20 ° C. At the end, DNA quality, purity and integrity were measured using a spectrophotometer (NanoDrop 2000-Thermo Scientific), using OD 260/280 and 260/230. Considering ideal values for both reasons, between 1.8 and 2.2.

  Baseline (at the beginning of the study)

Secondary Outcomes (3)

• Probing pocket depth (PD)

  Baseline (at the beginning of the study)

• Plaque index (PI)

  Baseline (at the beginning of the study)

• Bleeding on probing (BOP)

  Baseline (at the beginning of the study)

Study Arms (1)

Smokers/Non-smokers

It was an experimental study with parallel controls, comparing two groups, a group with patients who smoked for more than 10 years, consuming 10 more cigarettes per day and diagnosing chronic periodontitis (case) and another group (control) were non-smokers with chronic periodontitis, according to the standard of World Health Organization (WHO) definition of the smoking population

Genetic: oral epithelial cells obtained by rinsing with 3% sucrose

Interventions

oral epithelial cells obtained by rinsing with 3% sucrose GENETIC

rinsing with 3% sucrose, for a single time of collection, patients received periodontal treatment after collection and data analysis.

Smokers/Non-smokers

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who smoked for more than 10 years, consuming 10 more cigarettes per day and diagnosing chronic periodontitis (case) and another group (control) were non-smokers with chronic periodontitis, according to the standard of WHO definition of the smoking population,The ChP was diagnose in accordance with the recommended standards from the Center for Disease control and Prevention, the American Academy of Periodontology on the condition of patients in good general health, aged over 30 years, presenting with pocket periodontal disease with CAL ≥ 5 mm and radiographic bone loss and bleeding after probing.

You may qualify if:

• Chronic Periodontitis carriers - presence of proximal insertion loss ≥5 mm in more than 30% of the teeth present.
• Periodontal pocket ≥ 5mm
• Smokers who have smoked 10 or more cigarettes per day for the past five years.
• No positive history of basic periodontal treatment in the last six months.

You may not qualify if:

• Extensive prosthetic involvement.
• Using anti-inflammatories.
• Pregnant or nursing.
• Presence of systemic alterations that compromise host response or require prophylactic medication for treatment.
• History of constant use of oral antiseptics in the last six months.

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (1)

Arthur Belem Novaes Junior

Ribeirão Preto, São Paulo, 14040-904, Brazil

Location

Biospecimen

Retention: SAMPLES WITH DNA

ephitelials cells of oral mocose

MeSH Terms

Conditions

Periodontal Diseases

Interventions

Sucrose

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Disaccharides; Oligosaccharides; Polysaccharides; Carbohydrates; Sugars

Study Officials

• Arthur B. Novaes Junior, DDS, PhD

  Study Principal Investigator

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Teacher of Periodontia- Department of Buco Maxillofacial Surgery and Traumatology and Periodontics

Study Record Dates

• First Submitted: November 30, 2017
• First Posted: December 13, 2017
• Study Start: June 6, 2016
• Primary Completion: October 16, 2017
• Study Completion: November 18, 2017
• Last Updated: December 13, 2017

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be available within 2 years of study completion
• Access Criteria: Data access criteria will be reviewed by the an external independent review panel.

Locations

BR (1)