Clinical trial NCT02835898: Epigenetics and Periodontal Treatment
Official title: The Effect of Periodontal Therapy on Epigenetic Changes: A Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Periodontitis
Lead sponsor: University of Milan
Sponsor class: OTHER
First posted: 2016-07-18
Enrollment: 20
Sex: ALL
Minimum age (years): 26
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Two groups: ten patients with chronic periodontitis and ten individuals with healthy periodontium

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.

Eligibility criteria: 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

Primary outcomes:
measure: Changes in in the levels of DNA methylation (type of epigenetic modification) following periodontal therapy
timeFrame: 0, 15 days after periodontal therapy, 2 months after periodontal therapy
Secondary outcomes:
Other outcomes:
Locations:
city: Piacenza
country: Italy
facility: Studio Odontoiatrico Professor Rasperini
state: PC
Study officials:
affiliation: University of Milan
name: Giulio Rasperini, DDS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.