Epigenetics and Periodontal Treatment

NCT02835898 | Completed

• 1 other identifier: Epigenetics
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Objective: The aim of this pilot study is to evaluate the alterations of epigenetic patterns in periodontally diseased individuals, before and after periodontal treatment, also in comparison to periodontally healthy patients. Materials \& methods: Twenty patients were voluntarily enrolled in two groups: 10 participants with healthy periodontium, and 10 participants with chronic periodontitis. Clinical parameters were recorded and gingival biopsies were collected within the following timelines: At baseline (for both groups), after 15 days (for the diseased group only) and after two months (for the diseased group only).

Conditions

Periodontitis

Outcome Measures

Primary Outcomes (1)

• Changes in in the levels of DNA methylation (type of epigenetic modification) following periodontal therapy

  0, 15 days after periodontal therapy, 2 months after periodontal therapy

Study Arms (2)

Test Group

Patients with periodontal disease that need conventional periodontal treatment

Other: Conventional periodontal treatment

Control Group

Periodontally-healthy individuals.

Interventions

Conventional periodontal treatment OTHER

Conventional routine periodontal treatment will be done for patients in test group

Test Group

Eligibility Criteria

• Age: 26 Years - 69 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Two groups: ten patients with chronic periodontitis and ten individuals with healthy periodontium

You may qualify if:

• All participants should be systemically healthy
• All patients should be non-smokers
• Study participants should not be on antibiotics or non-steroidal anti-inflammatory drugs (NSAIDs) within one month before enrolment in the study
• All participants should be of a Caucasian ethnicity

You may not qualify if:

• Patients with systemic diseases
• Smoking patients
• Patients taking antibiotics or NSAIDs

Sponsors & Collaborators

• University of Milan: lead

Study Sites (1)

Studio Odontoiatrico Professor Rasperini

Piacenza, PC, 29121, Italy

Location

Related Publications (1)

• Asa'ad F, Bollati V, Pagni G, Castilho RM, Rossi E, Pomingi F, Tarantini L, Consonni D, Giannobile WV, Rasperini G. Evaluation of DNA methylation of inflammatory genes following treatment of chronic periodontitis: A pilot case-control study. J Clin Periodontol. 2017 Sep;44(9):905-914. doi: 10.1111/jcpe.12783. Epub 2017 Aug 17.

  PMID: 28736819 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Gingival biopsies will be collected in tubes that contain Allprotect tissue reagent (100 ml, Qiagen, USA), to immediately and effectively stabilize the DNA in tissues, based on the manufacturer's instructions. Tubes containing the reagent will be stored at 2-8 C. Later DNA/RNA will be purified using AllPrep DNA/RNA Mini Kit (50 ml, Qiagen, USA), following the manufacturer's instructions. With this approach, quantitative gene expression of specific cytokines is possible.

MeSH Terms

Conditions

Periodontitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Giulio Rasperini, DDS

  University of Milan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of periodontology

Study Record Dates

• First Submitted: July 7, 2016
• First Posted: July 18, 2016
• Study Start: September 1, 2015
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: July 18, 2016

Record last verified: 2016-07

Locations

IT (1)