SmokingNCT04430764
The Effect of Smoking and Non-surgical Periodontal Treatment on Gingival Crevicular Fluid Cyclophilin A and EMMPRIN Levels
A study testing non-surgical periodontal treatment in people with Smoking and Periodontitis, run by Ege University.
Trial summary
This study aimed to investigate the effect of smoking and non-surgical periodontal treatment on gingival crevicular fluid CyPA and EMMPRIN levels in patients with periodontitis. Twenty-eight patients with periodontitis (14 non-smoker and 14 smoker) and 30 control subjects (15 non-smoker and 15 smoker) were included… Read more about this study
- Who is it for?
- Ages 29 to 61 yearsHealthy volunteers can take part
- Conditions the study is for
- Smoking, Periodontitis, Non-surgical Periodontal Treatment
- What is being tested?
- non-surgical periodontal treatment
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- No sites listed yet
- Study dates
- Oct 2014to Aug 2015
- Phase
- Interventional
- 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 29 to 61 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- generalized periodontitis with stage III-IV \& Grade B
- no systemic and periodontal diseases
- smokers (minimum 10 cigarettes per day for at least ten years)
- non-smokers (never smoked)
Who cannot join
- Systemic diseases
- Infectious diseases
- Pregnancy or lactating
- Having periodontal treatment during the last 6 months
- Having antibiotic treatment within the past 3 months
- Former smokers
About this study
This study aimed to investigate the effect of smoking and non-surgical periodontal treatment on gingival crevicular fluid CyPA and EMMPRIN levels in patients with periodontitis. Twenty-eight patients with periodontitis (14 non-smoker and 14 smoker) and 30 control subjects (15 non-smoker and 15 smoker) were included into the study. Non-surgical periodontal treatment was applied to all periodontitis patients. Periodontal parameters and GCF CyPA and EMMPRIN levels were evaluated during 3 months following non-surgical periodontal treatment. GCF CyPA and EMMPRIN levels were analyzed by ELISA.
- Conditions
- Smoking, Periodontitis, Non-surgical Periodontal Treatment
- Being tested
- non-surgical periodontal treatment
- Medical subject headings
- Smoking, Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
non-surgical periodontal treatmentProcedure or surgery
Non-surgical periodontal treatment program was as following: First, motivation and oral hygiene instructions were given to all participants with periodontitis. The modified-Bass tooth brushing technique with a given dentifrice and toothbrush twice a day, and dental flossing/ interdental brushing once a day was advised to all patients with periodontitis. Second, scaling using an ultrasonic device and root planning by hand instruments under local anesthesia was performed.
| Study group | Role | What they receive |
|---|---|---|
| smoker | Experimental | Not described Receives: Procedure: non-surgical periodontal treatment |
| non-smoker | Active comparator | Not described Receives: Procedure: non-surgical periodontal treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in gingival crevicular fluid CypA total amounts
GCF CyPA levels were analyzed by ELISA
Measured: Baseline, 1 week, 1., 3. months
Change in gingival crevicular fluid EMMPRIN total amounts
GCF EMMPRIN levels were analyzed by ELISA
Measured: Baseline, 1 week, 1., 3. months
Secondary outcomes (2)
Change in probing depth
Probing depth was measured with Williams periodontal probe.
Measured: Baseline, 1., 3. months
Change in bleeding on probing
Bleeding on probing was evaluated the presence or absense following bleeding upon probing.
Measured: Baseline, 1., 3. months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2020
- Study startOct 2014
- Primary completionAug 2015
- Study completionAug 2015
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.
- More trials run by Ege 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Oya Turkoglu, Ege University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04430764
- Sponsor's protocol ID
- 2014/Diş/019
- Status last verified
- Jun 2020
- First submitted
- 9 Jun 2020
- Last updated
- 12 Jun 2020
- Results posted
- 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 12 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Smoking and Non-surgical Periodontal Treatment on Gingival Crevicular Fluid Cyclophilin A and EMMPRIN Levels
- ClinicalTrials.gov ID
- NCT04430764
- Acronym / sponsor ID
- 2014/Diş/019
- Conditions
- Smoking, Periodontitis, Non-surgical Periodontal Treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Study start
- Oct 2014 (actual)
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 12 Jun 2020 (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 aimed to investigate the effect of smoking and non-surgical periodontal treatment on gingival crevicular fluid CyPA and EMMPRIN levels in patients with periodontitis. Twenty-eight patients with periodontitis (14 non-smoker and 14 smoker) and 30 control subjects (15 non-smoker and 15 smoker) were included into the study. Non-surgical periodontal treatment was applied to all periodontitis patients. Periodontal parameters and GCF CyPA and EMMPRIN levels were evaluated during 3 months following non-surgical periodontal treatment. GCF CyPA and EMMPRIN levels were analyzed by ELISA.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| smoker | Experimental | Procedure: non-surgical periodontal treatment |
| non-smoker | Active comparator | Procedure: non-surgical periodontal treatment |
Who may qualify
- Ages
- 29 to 61 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- generalized periodontitis with stage III-IV \& Grade B
- no systemic and periodontal diseases
- smokers (minimum 10 cigarettes per day for at least ten years)
- non-smokers (never smoked)
Key exclusion criteria (6 listed)
- Systemic diseases
- Infectious diseases
- Pregnancy or lactating
- Having periodontal treatment during the last 6 months
- Having antibiotic treatment within the past 3 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 |
|---|---|---|
| non-surgical periodontal treatmentNon-surgical periodontal treatment program was as following: First, motivation and oral hygiene instructions were given to all participants with periodontitis. The modified-Bass tooth brushing technique with a given dentifrice and toothbrush twice a day, and dental flossing/ interdental brushing once a day was advised to all patients with periodontitis. Second, scaling using an ultrasonic device and root planning by hand instruments under local anesthesia was performed. | Procedure or surgery | non-smoker, smoker |
Primary outcome
Change in gingival crevicular fluid CypA total amounts
Time frame: Baseline, 1 week, 1., 3. months
GCF CyPA levels were analyzed by ELISA
Change in gingival crevicular fluid EMMPRIN total amounts
Time frame: Baseline, 1 week, 1., 3. months
GCF EMMPRIN levels were analyzed by ELISA
2 secondary outcomes
Change in probing depth
Time frame: Baseline, 1., 3. months
Change in bleeding on probing
Time frame: Baseline, 1., 3. months
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 12 Jun 2020.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing non-surgical periodontal treatment in people with Smoking and Periodontitis, run by Ege University.
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 6 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 12 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Change in gingival crevicular fluid CypA total amounts (time frame: Baseline, 1 week, 1., 3. months). The study lists 2 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 12 Jun 2020.