PeriodontitisNCT02835898
Epigenetics and Periodontal Treatment
An observational study of Periodontitis, run by University of Milan at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 26 to 69 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontitis
- What is being tested?
- Conventional periodontal treatment
- How many people
- 20 participants
- Where
- 1 siteItaly
- Study dates
- Sep 2015to Jun 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 26 to 69 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Two groups: ten patients with chronic periodontitis and ten individuals with healthy periodontium
Who may be able to join
- 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
Who cannot join
- Patients with systemic diseases
- Smoking patients
- Patients taking antibiotics or NSAIDs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
Read the 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
- Periodontitis
- Being tested
- Conventional periodontal treatment
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional periodontal treatmentOther
Conventional routine periodontal treatment will be done for patients in test group
| Study group | Role | What they receive |
|---|---|---|
| Test Group | Patients with periodontal disease that need conventional periodontal treatment Receives: Other: Conventional periodontal treatment | |
| Control Group | Periodontally-healthy individuals. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in in the levels of DNA methylation (type of epigenetic modification) following periodontal therapy
Measured: 0, 15 days after periodontal therapy, 2 months after periodontal therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2016 (estimated)
- Study startSep 2015
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PeriodontitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Milan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giulio Rasperini, University of Milan
- Investigators
- Giulio Rasperini, DDS, Principal investigator, University of Milan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02835898
- Sponsor's protocol ID
- Epigenetics
- Status last verified
- Jul 2016
- First submitted
- 7 Jul 2016
- Last updated
- 18 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 28736819
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Periodontal Therapy on Epigenetic Changes: A Pilot Study
- ClinicalTrials.gov ID
- NCT02835898
- Acronym / sponsor ID
- Epigenetics
- Conditions
- Periodontitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of MilanUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 18 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test Group | – | Other: Conventional periodontal treatmentPatients with periodontal disease that need conventional periodontal treatment |
| Control Group | – | –Periodontally-healthy individuals. |
Who may qualify
- Ages
- 26 to 69 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Two groups: ten patients with chronic periodontitis and ten individuals with healthy periodontium
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Patients with systemic diseases
- Smoking patients
- Patients taking antibiotics or NSAIDs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conventional periodontal treatmentConventional routine periodontal treatment will be done for patients in test group | Other | Test Group |
Primary outcome
Changes in in the levels of DNA methylation (type of epigenetic modification) following periodontal therapy
Time frame: 0, 15 days after periodontal therapy, 2 months after periodontal therapy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2016.
- Derived from this study: PubMed 28736819Asa'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.
- Individual participant dataSharing planned: Undecided
Related trials for Periodontitis
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Characterization of Small Intestinal Bacterial Overgrowth and Intestinal Barrier-Related Biomarkers in Patients With Severe Periodontitis: A Pilot Prospective Longitudinal Observational Cohort Study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Giulio Rasperini, DDS principal investigator
University of Milan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Periodontitis, run by University of Milan at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in in the levels of DNA methylation (type of epigenetic modification) following periodontal therapy (time frame: 0, 15 days after periodontal therapy, 2 months after periodontal therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02835898, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2016.