SmokingNCT06561971
Effect of Different Centrifuge Values on Saliva High Sensitive C-Reactive Protein (Hs-CRP) Levels in Individuals With Different Smoking Amounts
A study testing saliva obtaining in people with Smoking, run by Izmir Katip Celebi University at 1 site in Turkey (Türkiye).
Trial summary
The purpose of this study; In periodontally healthy individuals, high sensitive c-reactive protein (hs-CRP) levels of non-smokers, smokers of less than 10 cigarettes per day and smokers of more than 10 cigarettes per day were measured at 15 rpm-10 min, 10 centrifuge values, which are frequently used in saliva studies. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Smoking
- What is being tested?
- saliva obtaining
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2024to 22 Jan 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Systemically healthy
- Periodontally clinical healthy
- At least 20 permanent teeth in the mouth
- No medication for continuous use
- Those who have not used antibiotics, anti-inflammatory and systemic corticosteroid drugs in the last 6 months.
- Not in pregnancy or lactation period.
Show all 10Show fewer
- Not received periodontal treatment in the last 6 months
- For the non-smoker group; person who does not smoke tobacco
- For the light-smoker group; person who smokes less than 10 cigarettes a day
- For heavy-smoker group; person who smokes more than 10 cigarettes a day
Who cannot join
- Any oral or systemic disease
- Regularly using a systemic medication
- During pregnancy or lactation
- Received periodontal treatment within the last 6 months.
- Those who received antibiotic, anti-inflammatory or systemic corticosteroid medication in the last 6 months
- Individual with periodontal disease
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Mehmet Sağlam contact
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Izmir Katip Çelebi University Department of Periodontology
Izmir, Çiğli, 35640
Ece Özer, +905306918625, ozerrece@gmail.com
About this study
Official title: Evaluating the Effect of Smoking Amount on Determining Salivary High Sensitive C-Reactive Protein(Hs-CRP) Values by Centrifuging the Saliva of the Same Individuals at Different Rpm and Time.
The purpose of this study; In periodontally healthy individuals, high sensitive c-reactive protein (hs-CRP) levels of non-smokers, smokers of less than 10 cigarettes per day and smokers of more than 10 cigarettes per day were measured at 15 rpm-10 min, 10 centrifuge values, which are frequently used in saliva studies. To determine the levels in saliva samples as a result of rpm-10 min and 10 rpm 6 min centrifugations and to determine the values at which a cytokine of this molecular weight should be centrifuged and to examine the possible correlation between these values and the clinical parameters of the amount of smoking. Materials and Methods: saliva samples were collected from 90 systemically healthy individuals who were non-smokers (N, n=30), light smokers <10 cigarettes per day (L, n=30) and heavy smokers >10 cigarettes per day (H, n=20). samples were taken. Full-mouth clinical periodontal measurements, including probing depth (PD), clinical attachment level (CAL), bleeding on probing (BOP), gingival index (GI), and plaque index (PI), were also recorded. Enzyme-linked immunosorbent assay (ELISA) was used to determine hs-CRP levels in biological samples.
- Conditions
- Smoking
- Being tested
- saliva obtaining
- Medical subject headings
- Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
saliva obtainingDiagnostic test
The patient was asked to sit upright and tilt his/her head forward to collect saliva samples. İn this way, unstimulated saliva was allowed to accumulate in the floor of the mouth. The accumulated saliva was collected in a sterile container. It was then transferred to a propylene tube. The tubes were centrifuged and the clear part at the top of the tube was taken with a sterile syringe and transferred to a different propylene tube with 0.5 ml in each tube. Tubes were stored at -80ºC until the day of analysis.
| Study group | Role | What they receive |
|---|---|---|
| Non-Smokers | Experimental | Full-mouth clinical periodontal measurements recorded and saliva obtained. Receives: Diagnostic Test: saliva obtaining |
| Light Smokers | Experimental | Full-mouth clinical periodontal measurements recorded and saliva obtained. Receives: Diagnostic Test: saliva obtaining |
| Heavy Smokers | Experimental | Full-mouth clinical periodontal measurements recorded and saliva obtained. Receives: Diagnostic Test: saliva obtaining |
What is being measured
The primary outcome is the main question the study is designed to answer.
The total amount of hs-CRP in saliva
Measured: 24 hours after taking the clinical measurements at the first visit
Secondary outcomes (1)
Determining the ideal centrifugal value range of hs-CRP saliva level
Measured: Within 1 week after receiving the biochemical analysis results
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2024
- Study start1 Jun 2024
- Primary completion1 Aug 2024
- Study completion22 Jan 2025 (estimated)
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- According to full-mouth clinical periodontal measurements including probing depth (PD), clinical attachment level (CAL),bleeding on probing (BOP), gingival index (GI) and plaque index (PI) samples of saliva were obtained from 90 systemically healthy non-smoker individuals with heavy smokers (H, n=30), light smokers(L, n=30) and non-smokers (N, n=30).
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Izmir Katip Celebi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ece Ozer, Izmir Katip Celebi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06561971
- Sponsor's protocol ID
- 2024-SAEK-0029
- Status last verified
- Dec 2024
- First submitted
- 16 Aug 2024
- Last updated
- 20 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Effect of Smoking Amount on Determining Salivary High Sensitive C-Reactive Protein(Hs-CRP) Values by Centrifuging the Saliva of the Same Individuals at Different Rpm and Time.
- ClinicalTrials.gov ID
- NCT06561971
- Acronym / sponsor ID
- 2024-SAEK-0029
- Conditions
- Smoking
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Izmir Katip Celebi UniversityUniversity, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 1 Aug 2024 (actual)
- Study completion
- 22 Jan 2025 (estimated)
- First posted
- 20 Aug 2024 (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.
The purpose of this study; In periodontally healthy individuals, high sensitive c-reactive protein (hs-CRP) levels of non-smokers, smokers of less than 10 cigarettes per day and smokers of more than 10 cigarettes per day were measured at 15 rpm-10 min, 10 centrifuge values, which are frequently used in saliva studies. To determine the levels in saliva samples as a result of rpm-10 min and 10 rpm 6 min centrifugations and to determine the values at which a cytokine of this molecular weight should be centrifuged and to examine the possible correlation between these values and the clinical parameters of the amount of smoking. Materials and Methods: saliva samples were collected from 90 systemically healthy individuals who were non-smokers (N, n=30), light smokers <10 cigarettes per day (L, n=30) and heavy smokers >10 cigarettes per day (H, n=20). samples were taken. Full-mouth clinical periodontal measurements, including probing depth (PD), clinical attachment level (CAL), bleeding on probing (BOP), gingival index (GI), and plaque index (PI), were also recorded. Enzyme-linked immunosorbent assay (ELISA) was used to determine hs-CRP levels in biological samples.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- According to full-mouth clinical periodontal measurements including probing depth (PD), clinical attachment level (CAL),bleeding on probing (BOP), gingival index (GI) and plaque index (PI) samples of saliva were obtained from 90 systemically healthy non-smoker individuals with heavy smokers (H, n=30), light smokers(L, n=30) and non-smokers (N, n=30).
| Arm | Type | Receives |
|---|---|---|
| Non-Smokers | Experimental | Diagnostic Test: saliva obtainingFull-mouth clinical periodontal measurements recorded and saliva obtained. |
| Light Smokers | Experimental | Diagnostic Test: saliva obtainingFull-mouth clinical periodontal measurements recorded and saliva obtained. |
| Heavy Smokers | Experimental | Diagnostic Test: saliva obtainingFull-mouth clinical periodontal measurements recorded and saliva obtained. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Systemically healthy
- Periodontally clinical healthy
- At least 20 permanent teeth in the mouth
- No medication for continuous use
- Those who have not used antibiotics, anti-inflammatory and systemic corticosteroid drugs in the last 6 months.
Key exclusion criteria (6 listed)
- Any oral or systemic disease
- Regularly using a systemic medication
- During pregnancy or lactation
- Received periodontal treatment within the last 6 months.
- Those who received antibiotic, anti-inflammatory or systemic corticosteroid medication in the last 6 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 |
|---|---|---|
| saliva obtainingThe patient was asked to sit upright and tilt his/her head forward to collect saliva samples. İn this way, unstimulated saliva was allowed to accumulate in the floor of the mouth. The accumulated saliva was collected in a sterile container. It was then transferred to a propylene tube. The tubes were centrifuged and the clear part at the top of the tube was taken with a sterile syringe and transferred to a different propylene tube with 0.5 ml in each tube. Tubes were stored at -80ºC until the day of analysis. | Diagnostic test | Heavy Smokers, Light Smokers, Non-Smokers |
Primary outcome
The total amount of hs-CRP in saliva
Time frame: 24 hours after taking the clinical measurements at the first visit
1 secondary outcome
Determining the ideal centrifugal value range of hs-CRP saliva level
Time frame: Within 1 week after receiving the biochemical analysis results
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2024.
- Individual participant dataSharing planned: Yes
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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.
Mehmet Sağlam contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing saliva obtaining in people with Smoking, run by Izmir Katip Celebi 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 10 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: looking for participants now, as of the sponsor's last update on 20 Dec 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ece Özer (+90 5306958625, ozerrece@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The total amount of hs-CRP in saliva (time frame: 24 hours after taking the clinical measurements at the first visit). 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 20 Dec 2024.