SmokingNCT03631498
Apoptotic Changes in Gingiva Caused by Smoking
An observational study of Smoking and Chronic Periodontitis, run by Tokat Gaziosmanpasa University at 1 site in Turkey (Türkiye).
Trial summary
Smoking is a major environmental risk factor associated with common forms of human chronic periodontitis. The aim of the present study was to evaluate apoptotic tissue alterations and tissue destruction in smoker and non-smoker chronic periodontitis patients and healthy individuals. Read more about this study
- Who is it for?
- Ages 30 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Smoking, Chronic Periodontitis
- Type of treatment
- Pill or oral medicine
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Jan 2017to 10 Apr 2018
- 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 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Healthy individuals who were either smokers or non-smokers, chronic periodontitis patients who were either smokers or non-smokers older than 30 years old and younger than 50 years old were enrolled. The age was specifically chosen because aging changes periodontal and gingival tissues independently of other variables. Any possible factor which might alter connective tissue metabolism were excluded.
Who may be able to join
- Age range from 30 to 45,
- the existence of at least 20 functioning teeth,
- systemical health,
- no antibiotic use within 6 months,
- no periodontal therapy within 6 months,
- no pregnancy or lactation,
- no drug use, in addition; for the smokers existence of the smoking condition for at least five years.
Who cannot join
- Patients younger than 30 older than 50 years old,
- the absence of occlusion,
- drug use,
- pregnancy/lactation,
- previous antibiotic use,
- previous periodontal therapy,
- the existence of any systemical disease.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gaziosmanpasa University Faculty of Dentistry
Tokat Province, 60100
About this study
Official title: Apoptosis and Tissue Destruction in Gingival Tissues of Smoker and Non-smoker Periodontitis Patients
Smoking is a major environmental risk factor associated with common forms of human chronic periodontitis. The aim of the present study was to evaluate apoptotic tissue alterations and tissue destruction in smoker and non-smoker chronic periodontitis patients and healthy individuals. The investigators of the study suggest that smoking decrease tissue quality and increase inflammation level in gingival tissues in both healthy individuals and periodontitis patients. One possible mechanism for this is suggested to be increased apoptosis.
Read the detailed description
Periodontal disease disrupts soft tissue metabolism in the gingiva through a decrease in the production of collagen, the quality, and quantity of the connective tissue. The etiology and pathogenesis of chronic periodontitis are mostly revealed, however, the mechanism of environmental factors such as smoking yet to be clarified. Major consequences of smoking in gingival tissues are suggested to be the reduction in neutrophil and fibroblast function, decreased immunoglobulin G production, increased periodontal pathogen bacteria prevalence, difficulty in eliminating pathogens with mechanical therapy, and reduction in growth factor production. In the present study, markers of tissue destruction, matrix metalloproteinase-8 and tissue inhibitor of matrix metalloproteinase-1, hypoxia markers, vascular endothelial growth factor and hypoxia-inducible factor and apoptotic markers, bax, bcl-2, and caspase-3 were evaluated.
- Conditions
- Smoking, Chronic Periodontitis
- Keywords
- smoking, hypoxia, apoptosis, chronic periodontitis
- Medical subject headings
- Smoking, Chronic Periodontitis, Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Healthy individuals | Gingival biopsies of healthy individuals who were never-smokers and had no systemic or oral disease or condition. | |
| periodontitis patients | Gingival biopsies of periodontitis patients who were never-smokers and had no systemic disease or condition. | |
| Healthy smokers | Gingival biopsies of healthy individuals who were smokers but no systemic or oral disease or condition. | |
| Smokers with periodontitis | Gingival biopsies of periodontitis patients who were smokers but no systemic disease or condition. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fibroblast and total inflammatory cell counts
Fibroblast and total inflammatory cell counts in the groups were determined in a standardized 1000 micrometer square area with histomorphometric evaluation.
Measured: Biopsies were obtained a day after initial examinations, histological analysis were performed 2 weeks after.
Secondary outcomes (2)
Apoptotic markers
Apoptotic and anti-apoptotic proteins and enzymes related to apoptosis were evaluated via immunohistochemistry.
Measured: Biopsies were obtained a day after initial examinations, histological analysis were performed 2 weeks after
Hypoxia and tissue destruction markers
Vascular endothelial growth factor and hypoxia-inducible factor as hypoxia markers and matrix metalloproteinase and it inhibitor as destruction markers were evaluated via immunohistochemistry.
Measured: Biopsies were obtained a day after initial examinations, histological analysis were performed 2 weeks after
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2018
- Study start10 Jan 2017
- Primary completion10 Jan 2018
- Study completion10 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SmokingStudies 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
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tokat Gaziosmanpasa University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hatice Balci Yuce, Tokat Gaziosmanpasa University
- Investigators
- HATİCE BALCI YÜCE, PhD, Principal investigator, Gaziosmanpasa University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03631498
- Sponsor's protocol ID
- Ozkan
- Status last verified
- Aug 2018
- First submitted
- 13 Aug 2018
- Last updated
- 16 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Apoptosis and Tissue Destruction in Gingival Tissues of Smoker and Non-smoker Periodontitis Patients
- ClinicalTrials.gov ID
- NCT03631498
- Acronym / sponsor ID
- Ozkan
- Conditions
- Smoking, Chronic Periodontitis
- Keywords
- smoking, hypoxia, apoptosis, chronic periodontitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Tokat Gaziosmanpasa UniversityUniversity, hospital or other
- Study start
- 10 Jan 2017 (actual)
- Primary completion
- 10 Jan 2018 (actual)
- Study completion
- 10 Apr 2018 (actual)
- First posted
- 15 Aug 2018 (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.
Smoking is a major environmental risk factor associated with common forms of human chronic periodontitis. The aim of the present study was to evaluate apoptotic tissue alterations and tissue destruction in smoker and non-smoker chronic periodontitis patients and healthy individuals. The investigators of the study suggest that smoking decrease tissue quality and increase inflammation level in gingival tissues in both healthy individuals and periodontitis patients. One possible mechanism for this is suggested to be increased apoptosis.
Detailed description
Periodontal disease disrupts soft tissue metabolism in the gingiva through a decrease in the production of collagen, the quality, and quantity of the connective tissue. The etiology and pathogenesis of chronic periodontitis are mostly revealed, however, the mechanism of environmental factors such as smoking yet to be clarified. Major consequences of smoking in gingival tissues are suggested to be the reduction in neutrophil and fibroblast function, decreased immunoglobulin G production, increased periodontal pathogen bacteria prevalence, difficulty in eliminating pathogens with mechanical therapy, and reduction in growth factor production. In the present study, markers of tissue destruction, matrix metalloproteinase-8 and tissue inhibitor of matrix metalloproteinase-1, hypoxia markers, vascular endothelial growth factor and hypoxia-inducible factor and apoptotic markers, bax, bcl-2, and caspase-3 were evaluated.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Healthy individuals | – | –Gingival biopsies of healthy individuals who were never-smokers and had no systemic or oral disease or condition. |
| periodontitis patients | – | –Gingival biopsies of periodontitis patients who were never-smokers and had no systemic disease or condition. |
| Healthy smokers | – | –Gingival biopsies of healthy individuals who were smokers but no systemic or oral disease or condition. |
| Smokers with periodontitis | – | –Gingival biopsies of periodontitis patients who were smokers but no systemic disease or condition. |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy individuals who were either smokers or non-smokers, chronic periodontitis patients who were either smokers or non-smokers older than 30 years old and younger than 50 years old were enrolled. The age was specifically chosen because aging changes periodontal and gingival tissues independently of other variables. Any possible factor which might alter connective tissue metabolism were excluded.
Key inclusion criteria (7 listed)
- Age range from 30 to 45,
- the existence of at least 20 functioning teeth,
- systemical health,
- no antibiotic use within 6 months,
- no periodontal therapy within 6 months,
Key exclusion criteria (7 listed)
- Patients younger than 30 older than 50 years old,
- the absence of occlusion,
- drug use,
- pregnancy/lactation,
- previous antibiotic use,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Fibroblast and total inflammatory cell counts
Time frame: Biopsies were obtained a day after initial examinations, histological analysis were performed 2 weeks after.
Fibroblast and total inflammatory cell counts in the groups were determined in a standardized 1000 micrometer square area with histomorphometric evaluation.
2 secondary outcomes
Apoptotic markers
Time frame: Biopsies were obtained a day after initial examinations, histological analysis were performed 2 weeks after
Hypoxia and tissue destruction markers
Time frame: Biopsies were obtained a day after initial examinations, histological analysis were performed 2 weeks after
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 16 Aug 2018.
- Individual participant dataSharing planned: Undecided
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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.
HATİCE BALCI YÜCE, PhD principal investigator
Gaziosmanpasa University
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 Smoking and Chronic Periodontitis, run by Tokat Gaziosmanpasa University at 1 site in Turkey (Türkiye).
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 7 inclusion and 7 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 16 Aug 2018. 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 Turkey (Türkiye). 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?
Fibroblast and total inflammatory cell counts (time frame: Biopsies were obtained a day after initial examinations, histological analysis were performed 2 weeks after.). 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 16 Aug 2018.