- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02835898
Epigenetics and Periodontal Treatment
The Effect of Periodontal Therapy on Epigenetic Changes: A Pilot Study
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).
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
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PC
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Piacenza, PC, Italia, 29121
- Studio Odontoiatrico Professor Rasperini
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
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Test Group
Patients with periodontal disease that need conventional periodontal treatment
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Conventional routine periodontal treatment will be done for patients in test group
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Control Group
Periodontally-healthy individuals.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Changes in in the levels of DNA methylation (type of epigenetic modification) following periodontal therapy
Tidsramme: 0, 15 days after periodontal therapy, 2 months after periodontal therapy
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0, 15 days after periodontal therapy, 2 months after periodontal therapy
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Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Giulio Rasperini, DDS, University of Milan
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- Epigenetics
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
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