Epigenetics and Periodontal Treatment

Completed

• Conditions: Periodontitis
• Interventions: Other: Conventional periodontal treatment

• Registration Number: NCT02835898
• Lead Sponsor: University of Milan

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).

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 Timeline

• Study Start: 2015-09
• Primary Completion: 2016-06
• Study Completion: 2016-06
• Status Verified: 2016-07
• Study First Submitted: 2016-07-07
• Study First Submitted QC: 2016-07-15
• Last Update Submitted: 2016-07-15
• Study First Posted: 2016-07-18
• Last Update Posted: 2016-07-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Test Group	Conventional periodontal treatment	Patients with periodontal disease that need conventional periodontal treatment

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Studio Odontoiatrico Professor Rasperini; 🇮🇹 Piacenza, PC, Italy