Epigenetics and Periodontal Treatment

NCT ID: NCT02835898

Last Updated: 2016-07-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-09-30

Study Completion Date

2016-06-30

Brief Summary

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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

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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

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Periodontitis

Study Design

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Study Time Perspective

PROSPECTIVE

Study Groups

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Test Group

Patients with periodontal disease that need conventional periodontal treatment

Conventional periodontal treatment

Intervention Type OTHER

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

Control Group

Periodontally-healthy individuals.

No interventions assigned to this group

Interventions

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Conventional periodontal treatment

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

26 Years

Maximum Eligible Age

69 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Milan

OTHER

Sponsor Role lead

Responsible Party

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Giulio Rasperini

Professor of periodontology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Giulio Rasperini, DDS

Role: PRINCIPAL_INVESTIGATOR

University of Milan

Locations

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Studio Odontoiatrico Professor Rasperini

Piacenza, PC, Italy

Site Status

Countries

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Italy

References

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Asa'ad F, Bollati V, Pagni G, Castilho RM, Rossi E, Pomingi F, Tarantini L, Consonni D, Giannobile WV, Rasperini G. Evaluation of DNA methylation of inflammatory genes following treatment of chronic periodontitis: A pilot case-control study. J Clin Periodontol. 2017 Sep;44(9):905-914. doi: 10.1111/jcpe.12783. Epub 2017 Aug 17.

Reference Type DERIVED
PMID: 28736819 (View on PubMed)

Other Identifiers

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Epigenetics

Identifier Type: -

Identifier Source: org_study_id

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