Skip to main content
OpenTrials
Completed

NCT Number: NCT02835898

Epigenetics and Periodontal Treatment

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).

Completed

Looking for future studies?

Notify Me

Key information

Age range

26 year–69 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Studio Odontoiatrico Professor Rasperini

Piacenza, PC, 29121, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Conventional periodontal treatment

Other

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

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

University of Milan

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jul 18, 2016
Registry last updated
Jul 18, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.