Epigenetics and Periodontal Treatment

July 15, 2016 updated by: Giulio Rasperini, University of Milan

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Actual)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • PC
      • Piacenza, PC, Italy, 29121
        • Studio Odontoiatrico Professor Rasperini

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

26 years to 69 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Test Group
Patients with periodontal disease that need conventional periodontal treatment
Other: Conventional periodontal treatment
Conventional routine periodontal treatment will be done for patients in test group
Control Group
Periodontally-healthy individuals.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Changes in in the levels of DNA methylation (type of epigenetic modification) following periodontal therapy
Time Frame: 0, 15 days after periodontal therapy, 2 months after periodontal therapy
0, 15 days after periodontal therapy, 2 months after periodontal therapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Milan

Investigators

  • Principal Investigator: Giulio Rasperini, DDS, University of Milan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2015

Primary Completion (Actual)

June 1, 2016

Study Completion (Actual)

June 1, 2016

Study Registration Dates

First Submitted

July 7, 2016

First Submitted That Met QC Criteria

July 15, 2016

First Posted (Estimate)

July 18, 2016

Study Record Updates

Last Update Posted (Estimate)

July 18, 2016

Last Update Submitted That Met QC Criteria

July 15, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Epigenetics

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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