Trials / Completed
CompletedNCT02835898
Epigenetics and Periodontal Treatment
The Effect of Periodontal Therapy on Epigenetic Changes: A Pilot Study
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 20 (actual)
- Sponsor
- University of Milan · Academic / Other
- Sex
- All
- Age
- 26 Years – 69 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Conventional periodontal treatment | Conventional routine periodontal treatment will be done for patients in test group |
Timeline
- Start date
- 2015-09-01
- Primary completion
- 2016-06-01
- Completion
- 2016-06-01
- First posted
- 2016-07-18
- Last updated
- 2016-07-18
Locations
1 site across 1 country: Italy
Source: ClinicalTrials.gov record NCT02835898. Inclusion in this directory is not an endorsement.