Epigenetics and Periodontal Treatment

Periodontitis Clinical Trial

Official title:

The Effect of Periodontal Therapy on Epigenetic Changes: A Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02835898
• Other study ID #: Epigenetics
• Status: Completed
• Phase: Phase 1
• First received: July 7, 2016
• Last updated: July 15, 2016
• Start date: September 2015
• Est. completion date: June 2016

Study information

• Verified date: July 2016
• Source: University of Milan
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Observational

Clinical Trial 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).

Description:

Study Design Baseline: Before harvesting gingival biopsies, bleeding on probing (BOP), periodontal pocket depth (PPD) and clinical attachment level (CAL) were registered at the biopsy site, for all study participants. Following the registration of the clinical parameters, gingival biopsies were obtained from the periodontally-healthy individuals during crown lengthening surgery or surgical removal of wisdom teeth. In the periodontally-diseased group, biopsies were harvested from two sites: healthy site and periodontally-involved site. After harvesting of biopsies, patients with periodontal disease underwent scaling and root planing.

Two weeks after periodontal treatment: Clinical parameters were registered and gingival biopsies were harvested (from two sites) for the periodontally-diseased group only, to evaluate if the epigenetic patterns (DNA methylation) were altered by conventional periodontal therapy, in comparison to the patterns observed at baseline for both diseased and healthy groups.

Two months after initial periodontal treatment: Clinical parameters were registered and gingival biopsies were harvested (from two sites) for the periodontally-diseased group only, to evaluate if the epigenetic patterns were still altered by conventional periodontal therapy, in comparison to the patterns observed at baseline for both diseased and healthy groups, and at 15 days for the diseased group.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 26 Years to 69 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• Patients with systemic diseases

• Smoking patients

• Patients taking antibiotics or NSAIDs

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Periodontitis

Intervention

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

Locations

Country	Name	City	State
Italy	Studio Odontoiatrico Professor Rasperini	Piacenza	PC

Sponsors (1)

Lead Sponsor	Collaborator
University of Milan

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No