Chronic PeriodontitisGCFNCT04115176
GCF IL-17 Levels and Oxidative Status of Smoking and Non-smoking Individuals With Periodontitis
An observational study of Chronic Periodontitis and Smoking, Cigarette, run by Ondokuz Mayıs University at 1 site in Turkey (Türkiye).
Trial summary
This study was performed to evaluate the effects of both periodontal treatment and smoking on the gingival crevicular fluid(GCF) levels of interleukin (IL)-17A, IL-17E, Total oxidative stress(TOS) and total antioxidant capasity(TAOC) in smoking and non-smoking patients with severe chronic periodontitis. Read more about this study
- Who is it for?
- Ages 35 to 60 years
- Conditions the study is for
- Chronic Periodontitis, Smoking, Cigarette
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Oct 2017to 10 Jul 2019
- 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 35 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Patients with chronic periodontitis (with an age range of 35 to 60 years) seeking dental treatment at the Periodontology Clinic, School of Dentistry, Ondokuz Mayis University, were included in the present study.
Who may be able to join
- individuals aged ˃35 years and having ≥16 teeth diagnosed as chronic periodontitis
- not received any periodontal therapy within the previous 6 months;
- not received antibiotic/anti-inflammatory drug treatment within the previous 6 months.
Who cannot join
- receiving medical treatment for cancer, rheumatoid arthritis, diabetes mellitus, cardiovascular disease, or any other systemic disease;
- being pregnant or being in the period of menopause or lactation;
- receiving any drug therapy that might affect the clinical characteristics of periodontitis;
- usage of systemic antimicrobials during the 6 weeks prior to data collection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Smoking Effects on GCF GCF IL-17A AND IL-17 Levels and Oxidative Status of Patients Receiving Periodontal Treatment
This study was performed to evaluate the effects of both periodontal treatment and smoking on the gingival crevicular fluid(GCF) levels of interleukin (IL)-17A, IL-17E, Total oxidative stress(TOS) and total antioxidant capasity(TAOC) in smoking and non-smoking patients with severe chronic periodontitis.
Systemically healthy 15 smoker,15 non-smoker with chronic periodontitis were attended for the study. Periodontal status were determined by recording periodontal clinical measurements. GCF samples were collected at the baseline, at the end of initial periodontal treatment and 4 weeks after periodontal flap surgery. The data were tested statistically by the Student t and paired sample t tests.
- Conditions
- Chronic Periodontitis, Smoking, Cigarette
- Keywords
- chronic periodontitis, smoking,, periodontal treatment,, IL-17,, oxidative stress
- Medical subject headings
- Chronic Periodontitis, Cigarette Smoking, Smoking
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 |
|---|---|---|
| smokers + periodontitis | Individuals clinically diagnosed with chronic periodontitis that smoke recruited for this group. | |
| nonsmoker + periodontitis | Individuals clinically diagnosed with chronic periodontitis that don't smoke recruited for this group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
GCF IL-17A VOLUME
IL-17A is a cytokine present in gingival crevicular fluid. Its volume calculated as microliter and changes due to inflammation caused by periodontal disease.
Measured: GCF sampling was performed prior to periodontal treatment , 4 weeks after completion of initial periodontal treatment, and 4 weeks after periodontal flap surgery .
GCF IL-17E VOLUME
IL-17E is a cytokine present in gingival crevicular fluid. Its volume calculated as microliter and changes due to inflammation caused by periodontal disease.
Measured: GCF sampling was performed prior to periodontal treatment , 4 weeks after completion of initial periodontal treatment, and 4 weeks after periodontal flap surgery .
GCF TOTAL OXIDATIVE STRESS (TOS) LEVEL
TOS is the measurement of oxidative stress amount and given as mmol/L unit. Its amount changes due to inflammation caused by periodontal disease.
Measured: GCF sampling was performed prior to periodontal treatment , 4 weeks after completion of initial periodontal treatment, and 4 weeks after periodontal flap surgery .
GCF TOTAL ANTIOXIDANT CAPASITY (TAOC)
TAOC is the antioxidant amount measured and given as μmol H2O2 Eq/L unit. Its amount changes due to inflammation caused by periodontal disease.
Measured: GCF sampling was performed prior to periodontal treatment , 4 weeks after completion of initial periodontal treatment, and 4 weeks after periodontal flap surgery .
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2019
- Study start10 Oct 2017
- Primary completion10 Jul 2019
- Study completion10 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PeriodontitisStudies of the same condition, open and under way.
- More trials run by Ondokuz Mayıs UniversityThe 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
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ondokuz Mayıs University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, muge lutfioglu, Ondokuz Mayıs University
- Investigators
- MÜGE LÜTFİOĞLU, Principal investigator, assoc. prof.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04115176
- Sponsor's protocol ID
- PYO.DIS.1901.17.002
- Acronym
- GCF
- Status last verified
- Oct 2019
- First submitted
- 2 Oct 2019
- Last updated
- 4 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Smoking Effects on GCF GCF IL-17A AND IL-17 Levels and Oxidative Status of Patients Receiving Periodontal Treatment
- ClinicalTrials.gov ID
- NCT04115176
- Acronym / sponsor ID
- GCF / PYO.DIS.1901.17.002
- Conditions
- Chronic Periodontitis, Smoking, Cigarette
- Keywords
- chronic periodontitis, smoking,, periodontal treatment,, IL-17,, oxidative stress
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Ondokuz Mayıs UniversityUniversity, hospital or other
- Study start
- 10 Oct 2017 (actual)
- Primary completion
- 10 Jul 2019 (actual)
- Study completion
- 10 Jul 2019 (actual)
- First posted
- 3 Oct 2019 (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.
This study was performed to evaluate the effects of both periodontal treatment and smoking on the gingival crevicular fluid(GCF) levels of interleukin (IL)-17A, IL-17E, Total oxidative stress(TOS) and total antioxidant capasity(TAOC) in smoking and non-smoking patients with severe chronic periodontitis.
Systemically healthy 15 smoker,15 non-smoker with chronic periodontitis were attended for the study. Periodontal status were determined by recording periodontal clinical measurements. GCF samples were collected at the baseline, at the end of initial periodontal treatment and 4 weeks after periodontal flap surgery. The data were tested statistically by the Student t and paired sample t tests.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| smokers + periodontitis | – | –Individuals clinically diagnosed with chronic periodontitis that smoke recruited for this group. |
| nonsmoker + periodontitis | – | –Individuals clinically diagnosed with chronic periodontitis that don't smoke recruited for this group. |
Who may qualify
- Ages
- 35 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients with chronic periodontitis (with an age range of 35 to 60 years) seeking dental treatment at the Periodontology Clinic, School of Dentistry, Ondokuz Mayis University, were included in the present study.
Key inclusion criteria (3 listed)
- individuals aged ˃35 years and having ≥16 teeth diagnosed as chronic periodontitis
- not received any periodontal therapy within the previous 6 months;
- not received antibiotic/anti-inflammatory drug treatment within the previous 6 months.
Key exclusion criteria (4 listed)
- receiving medical treatment for cancer, rheumatoid arthritis, diabetes mellitus, cardiovascular disease, or any other systemic disease;
- being pregnant or being in the period of menopause or lactation;
- receiving any drug therapy that might affect the clinical characteristics of periodontitis;
- usage of systemic antimicrobials during the 6 weeks prior to data collection
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
GCF IL-17A VOLUME
Time frame: GCF sampling was performed prior to periodontal treatment , 4 weeks after completion of initial periodontal treatment, and 4 weeks after periodontal flap surgery .
IL-17A is a cytokine present in gingival crevicular fluid. Its volume calculated as microliter and changes due to inflammation caused by periodontal disease.
GCF IL-17E VOLUME
Time frame: GCF sampling was performed prior to periodontal treatment , 4 weeks after completion of initial periodontal treatment, and 4 weeks after periodontal flap surgery .
IL-17E is a cytokine present in gingival crevicular fluid. Its volume calculated as microliter and changes due to inflammation caused by periodontal disease.
GCF TOTAL OXIDATIVE STRESS (TOS) LEVEL
Time frame: GCF sampling was performed prior to periodontal treatment , 4 weeks after completion of initial periodontal treatment, and 4 weeks after periodontal flap surgery .
TOS is the measurement of oxidative stress amount and given as mmol/L unit. Its amount changes due to inflammation caused by periodontal disease.
GCF TOTAL ANTIOXIDANT CAPASITY (TAOC)
Time frame: GCF sampling was performed prior to periodontal treatment , 4 weeks after completion of initial periodontal treatment, and 4 weeks after periodontal flap surgery .
TAOC is the antioxidant amount measured and given as μmol H2O2 Eq/L unit. Its amount changes due to inflammation caused by periodontal disease.
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 4 Oct 2019.
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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.
MÜGE LÜTFİOĞLU principal investigator
assoc. prof.
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 Chronic Periodontitis and Smoking, Cigarette, run by Ondokuz Mayıs 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 3 inclusion and 4 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 4 Oct 2019. 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?
GCF IL-17A VOLUME (time frame: GCF sampling was performed prior to periodontal treatment , 4 weeks after completion of initial periodontal treatment, and 4 weeks after periodontal flap surgery .). The study lists 4 primary outcomes in all. 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 4 Oct 2019.