Periodontal DiseasesNCT03371446
DNA Methylation Profile of the SOCS-1 Gene Promoter in Smokers Patients With Chronic Periodontitis.
An observational study of Periodontal Diseases and Epigenetics, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
Periodontitis is related to host genetics, constitution of the dental biofilm and environmental factors such as smoking. DNA methylation is a mechanism of genetic expression that can inhibit or silence gene expression. Read more about this study
- Who is it for?
- Ages 30 years and olderHealthy volunteers can take part
- Conditions the study is for
- Periodontal Diseases, Epigenetics
- What is being tested?
- oral epithelial cells obtained by rinsing with 3% sucrose
- Type of treatment
- Pill or oral medicine
- How many people
- 60 participants
- Where
- 1 siteBrazil
- Study dates
- 6 Jun 2016to 18 Nov 2017
- 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 30 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients who smoked for more than 10 years, consuming 10 more cigarettes per day and diagnosing chronic periodontitis (case) and another group (control) were non-smokers with chronic periodontitis, according to the standard of WHO definition of the smoking population,The ChP was diagnose in accordance with the recommended standards from the Center for Disease control and Prevention, the American Academy of Periodontology on the condition of patients in good general health, aged over 30 years, presenting with pocket periodontal disease with CAL ≥ 5 mm and radiographic bone loss and bleeding after probing.
Who may be able to join
- Chronic Periodontitis carriers - presence of proximal insertion loss ≥5 mm in more than 30% of the teeth present.
- Periodontal pocket ≥ 5mm
- Smokers who have smoked 10 or more cigarettes per day for the past five years.
- No positive history of basic periodontal treatment in the last six months.
Who cannot join
- Extensive prosthetic involvement.
- Using anti-inflammatories.
- Pregnant or nursing.
- Presence of systemic alterations that compromise host response or require prophylactic medication for treatment.
- History of constant use of oral antiseptics in the last six months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Smoking on the DNA Methylation Profile of the SOCS 1 Gene Promoter in Oral Mucosal Epithelial Cells of Individuals With Chronic Periodontitis (Smokers and Nonsmokers).
Periodontitis is related to host genetics, constitution of the dental biofilm and environmental factors such as smoking. DNA methylation is a mechanism of genetic expression that can inhibit or silence gene expression. In this way several researchers have been dedicated to study the genetic influence on the susceptibility and / or increased risk to periodontal disease. Studies have reported association between several epigenetic biomarkers with periodontal inflammation. Considering the hypothesis that there is an association between smoking and methylation in genes related to periodontal disease, the objective of this study was to verify the DNA methylation pattern in oral epithelial cells of patients with chronic periodontitis (CP) in the promoter of a specific gene involved in the control of inflammation, as suppressor of cytokine signaling (SOCS) 1 in smokers and nonsmokers patients.
Read the detailed description
This was an experimental type study with parallel controls, comparing two groups, a group with consumption of 10 minimum cigarettes per day, with a diagnosis of chronic periodontitis. And another control group were non-smokers with chronic periodontitis. For this, genomic DNA was purified from oral epithelial cells obtained by rinsing with 3% sucrose, for a single time of collection, patients received periodontal treatment after collection and data analysis. The DNA was modified by Sodium bisulfite and the methylation patterns of the DNA were analyzed with the MSPCR technique (Polymerase chain reaction). This study was approved by the Institutional Review Board of the School of Dentistry of Ribeirão Preto (CAAE:57171816.2.0000.5419 ), and all patients need to provide written informed consent.
- Conditions
- Periodontal Diseases, Epigenetics
- Being tested
- oral epithelial cells obtained by rinsing with 3% sucrose
- Keywords
- DNA Methylation. Smoking. SOCS-1 gene.
- Medical subject headings
- Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oral epithelial cells obtained by rinsing with 3% sucroseGenetic
rinsing with 3% sucrose, for a single time of collection, patients received periodontal treatment after collection and data analysis.
| Study group | Role | What they receive |
|---|---|---|
| Smokers/Non-smokers | It was an experimental study with parallel controls, comparing two groups, a group with patients who smoked for more than 10 years, consuming 10 more cigarettes per day and diagnosing chronic periodontitis (case) and another group (control) were non-smokers with chronic periodontitis, according to the standard of World Health Organization (WHO) definition of the smoking population Receives: Genetic: oral epithelial cells obtained by rinsing with 3% sucrose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Extraction of genomic DNA from oral epithelial cells
Epithelial cells were collected after mouthwash with 5ml dextrose autoclaved 3% and stored under refrigeration at -20ºC. After collection, the samples were taken to the Epigenetics and Reproduction Laboratory of the Department of Genetics of the Medical School of Ribeirão Preto-USP (FMRP-USP) where nucleic acid extraction and molecular analysis were performed.
After thawing the saliva, 2ml of each sample collected were transferred separately to eppendorf tubes, for processing. The material was then diluted in 50 μl of cobalt Mili-Q water, incubated at 37 ° C in a water bath for 1 hour and stored in a freezer at -20 ° C. At the end, DNA quality, purity and integrity were measured using a spectrophotometer (NanoDrop 2000-Thermo Scientific), using OD 260/280 and 260/230. Considering ideal values for both reasons, between 1.8 and 2.2.
Measured: Baseline (at the beginning of the study)
Secondary outcomes (3)
Probing pocket depth (PD)
Clinical parameter was recorded at baseline by one trained periodontist.Probing pocket depth (PD) was measured from the free gingival margin to the bottom of the periodontal pocket and clinical attachment level ( CAL) was measured from the cementum-enamel junction (CEJ) to the bottom of periodontal pocket.
Probing measurement was performed using a manual University of North Carolina - UNC Periodontal probe (Hu- Friedy, Chicago, IL, USA).
Measured: Baseline (at the beginning of the study)
Plaque index (PI)
Clinical parameter was recorded at baseline by one trained periodontist. Plaque index (PI) was used to assess the oral hygiene status of the patients, the evaluation was done with the unit of measure in percentage (%) whole mouth. Probing measurement was performed using a manual University of North Carolina - UNC Periodontal probe (Hu- Friedy, Chicago, IL, USA).
Measured: Baseline (at the beginning of the study)
Bleeding on probing (BOP)
Clinical parameter was recorded at baseline by one trained periodontist.Bleeding on probing (BOP) was recorded based on the presence or absence of bleeding up to 30 seconds after probing on four sides of each tooth,the evaluation was done with the unit of measure in percentage (%) whole mouth. Probing measurement was performed using a manual University of North Carolina - UNC Periodontal probe (Hu- Friedy, Chicago, IL, USA).
Measured: Baseline (at the beginning of the study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2017
- Study start6 Jun 2016
- Primary completion16 Oct 2017
- Study completion18 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontal DiseasesStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- 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
- Observational model
- Case-control
- Time perspective
- Other
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arthur Belem Novaes Jr, University of Sao Paulo
- Investigators
- Arthur B. Novaes Junior, DDS, PhD, Principal investigator, Study Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03371446
- Sponsor's protocol ID
- CAAE: 57171816.2.0000.5419
- Status last verified
- Dec 2017
- First submitted
- 30 Nov 2017
- Last updated
- 13 Dec 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data will be made available with conclusion of study.
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Smoking on the DNA Methylation Profile of the SOCS 1 Gene Promoter in Oral Mucosal Epithelial Cells of Individuals With Chronic Periodontitis (Smokers and Nonsmokers).
- ClinicalTrials.gov ID
- NCT03371446
- Acronym / sponsor ID
- CAAE: 57171816.2.0000.5419
- Conditions
- Periodontal Diseases, Epigenetics
- Keywords
- DNA Methylation. Smoking. SOCS-1 gene.
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- 6 Jun 2016 (actual)
- Primary completion
- 16 Oct 2017 (actual)
- Study completion
- 18 Nov 2017 (actual)
- First posted
- 13 Dec 2017 (actual)
- 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.
Periodontitis is related to host genetics, constitution of the dental biofilm and environmental factors such as smoking. DNA methylation is a mechanism of genetic expression that can inhibit or silence gene expression. In this way several researchers have been dedicated to study the genetic influence on the susceptibility and / or increased risk to periodontal disease. Studies have reported association between several epigenetic biomarkers with periodontal inflammation. Considering the hypothesis that there is an association between smoking and methylation in genes related to periodontal disease, the objective of this study was to verify the DNA methylation pattern in oral epithelial cells of patients with chronic periodontitis (CP) in the promoter of a specific gene involved in the control of inflammation, as suppressor of cytokine signaling (SOCS) 1 in smokers and nonsmokers patients.
Detailed description
This was an experimental type study with parallel controls, comparing two groups, a group with consumption of 10 minimum cigarettes per day, with a diagnosis of chronic periodontitis. And another control group were non-smokers with chronic periodontitis. For this, genomic DNA was purified from oral epithelial cells obtained by rinsing with 3% sucrose, for a single time of collection, patients received periodontal treatment after collection and data analysis. The DNA was modified by Sodium bisulfite and the methylation patterns of the DNA were analyzed with the MSPCR technique (Polymerase chain reaction). This study was approved by the Institutional Review Board of the School of Dentistry of Ribeirão Preto (CAAE:57171816.2.0000.5419 ), and all patients need to provide written informed consent.
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Smokers/Non-smokers | – | Genetic: oral epithelial cells obtained by rinsing with 3% sucroseIt was an experimental study with parallel controls, comparing two groups, a group with patients who smoked for more than 10 years, consuming 10 more cigarettes per day and diagnosing chronic periodontitis (case) and another group (control) were non-smokers with chronic periodontitis, according to the standard of World Health Organization (WHO) definition of the smoking population |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who smoked for more than 10 years, consuming 10 more cigarettes per day and diagnosing chronic periodontitis (case) and another group (control) were non-smokers with chronic periodontitis, according to the standard of WHO definition of the smoking population,The ChP was diagnose in accordance with the recommended standards from the Center for Disease control and Prevention, the American Academy of Periodontology on the condition of patients in good general health, aged over 30 years, presenting with pocket periodontal disease with CAL ≥ 5 mm and radiographic bone loss and bleeding after probing.
Key inclusion criteria (4 listed)
- Chronic Periodontitis carriers - presence of proximal insertion loss ≥5 mm in more than 30% of the teeth present.
- Periodontal pocket ≥ 5mm
- Smokers who have smoked 10 or more cigarettes per day for the past five years.
- No positive history of basic periodontal treatment in the last six months.
Key exclusion criteria (5 listed)
- Extensive prosthetic involvement.
- Using anti-inflammatories.
- Pregnant or nursing.
- Presence of systemic alterations that compromise host response or require prophylactic medication for treatment.
- History of constant use of oral antiseptics in the last six months.
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 |
|---|---|---|
| oral epithelial cells obtained by rinsing with 3% sucroserinsing with 3% sucrose, for a single time of collection, patients received periodontal treatment after collection and data analysis. | Genetic | Smokers/Non-smokers |
Primary outcome
Extraction of genomic DNA from oral epithelial cells
Time frame: Baseline (at the beginning of the study)
Epithelial cells were collected after mouthwash with 5ml dextrose autoclaved 3% and stored under refrigeration at -20ºC. After collection, the samples were taken to the Epigenetics and Reproduction Laboratory of the Department of Genetics of the Medical School of Ribeirão Preto-USP (FMRP-USP) where nucleic acid extraction and molecular analysis were performed. After thawing the saliva, 2ml of each sample collected were transferred separately to eppendorf tubes, for processing. The material was then diluted in 50 μl of cobalt Mili-Q water, incubated at 37 ° C in a water bath for 1 hour and stored in a freezer at -20 ° C. At the end, DNA quality, purity and integrity were measured using a spectrophotometer (NanoDrop 2000-Thermo Scientific), using OD 260/280 and 260/230. Considering ideal values for both reasons, between 1.8 and 2.2.
3 secondary outcomes
Probing pocket depth (PD)
Time frame: Baseline (at the beginning of the study)
Plaque index (PI)
Time frame: Baseline (at the beginning of the study)
Bleeding on probing (BOP)
Time frame: Baseline (at the beginning of the study)
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 13 Dec 2017.
- Individual participant dataSharing planned: Yes. Individual participant data will be made available with conclusion of 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.
Arthur B. Novaes Junior, DDS, PhD principal investigator
Study Principal Investigator
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 Periodontal Diseases and Epigenetics, run by University of Sao Paulo at 1 site in Brazil.
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 5 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 13 Dec 2017. 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 Brazil. 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?
Extraction of genomic DNA from oral epithelial cells (time frame: Baseline (at the beginning of the study)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Dec 2017.