Periodontitis (Stage 3)NCT07870473
Evaluation of the Effect of Smoking on Apelin, Periostin, and High-Sensitivity CRP Levels in Gingival Crevicular Fluid and Serum
An observational study of Periodontitis (Stage 3) and Periodontal Health, run by Pamukkale University at 1 site in Turkey (Türkiye).
Trial summary
Periodontal health is influenced by various local and systemic factors, with smoking being one of the major environmental risk factors. This clinical study is designed to investigate the biochemical profiles of individuals by measuring apelin, periostin, and high-sensitivity C-reactive protein (hs-CRP) levels in both… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontitis (Stage 3), Periodontal Health, Smoking Cigarette
- How many people
- 85 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 7 Jan 2025to 31 Jan 2027
- Phase
- Observational
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population will comprise systemically healthy individuals and patients diagnosed with Stage III Periodontitis, categorized by their smoking status, who are admitted to the Department of Periodontology.
Who may be able to join
- General Inclusion Criteria (All Groups):
- Age 18 years or older.
- No history of systemic diseases that could affect periodontal status.
- For Group 1 (Non-smoking Periodontally Healthy):
- Never smoked in the past 10 years.
- Probing pocket depth (PPD) ≤3 mm and no clinical attachment loss (CAL) in the sampled teeth.
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- Absence of gingival inflammation and no history of periodontal disease.
- Bleeding on probing (BOP) affecting less than 10% of total sites.
- Good oral hygiene and no more than 4 missing teeth (excluding third molars).
- For Group 2 (Smoking Periodontally Healthy):
- History of smoking at least 10 cigarettes per day for 5 or more years.
- Probing pocket depth (PPD) ≤3 mm and no clinical attachment loss (CAL) in the sampled teeth.
- Absence of gingival inflammation and no history of periodontal disease.
- Bleeding on probing (BOP) affecting less than 10% of total sites.
- Good oral hygiene and no more than 4 missing teeth (excluding third molars).
- For Group 3 (Non-smoking Stage III Periodontitis):
- Never smoked in the past 10 years.
- Diagnosed with generalized Stage III Periodontitis
- Presence of periodontal pockets with probing depth ≥6 mm in the sampled teeth.
- Radiographic evidence of bone loss.
- Absence of any restoration on the teeth selected for sampling.
- No more than 4 missing teeth (excluding third molars).
- For Group 4 (Smoking Stage III Periodontitis):
- History of smoking at least 10 cigarettes per day for 5 or more years.
- Diagnosed with generalized Stage III Periodontitis
- Presence of periodontal pockets with probing depth ≥6 mm in the sampled teeth.
- Radiographic evidence of bone loss.
- Absence of any restoration on the teeth selected for sampling.
- No more than 4 missing teeth (excluding third molars).
Who cannot join
- Individuals under the age of 18
- Individuals with a systemic disease
- Cancer patients and those with a history of chemotherapy or radiation therapy
- Pregnant and breastfeeding women
- People who have quit smoking
- Having undergone any periodontal surgical procedure within the last 12 months prior to treatment,
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- Having undergone periodontal treatment within the last 6 months
- Having undergone orthodontic treatment within the last 6 months
- Having taken antibiotics, anti-inflammatory drugs, or any other medication within the last 6 months
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Pamukkale University Faculty of Dentistry Departmant of Periodontology
Denizli, Denizli, 20160
About this study
Periodontal health is influenced by various local and systemic factors, with smoking being one of the major environmental risk factors. This clinical study is designed to investigate the biochemical profiles of individuals by measuring apelin, periostin, and high-sensitivity C-reactive protein (hs-CRP) levels in both gingival crevicular fluid and serum. The participants will be divided into specific study groups based on their smoking status and periodontal condition. Samples of gingival crevicular fluid and serum will be collected under standard clinical protocols, and biomarker concentrations will be analyzed quantitatively using the ELISA (Enzyme-Linked Immunosorbent Assay) method to evaluate their potential correlation with periodontal status.
- Medical subject headings
- Periodontitis, Cigarette 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 |
|---|---|---|
| Non-smoking Periodontally Healthy | Systemically and periodontally healthy individuals who do not smoke. Gingival crevicular fluid and serum samples will be collected from this group for biochemical analysis. | |
| Smoking Periodontally Healthy | Systemically healthy individuals who are periodontally healthy and have a history of smoking. Gingival crevicular fluid and serum samples will be collected from this group for biochemical analysis. | |
| Non-smoking Stage III Periodontitis | Non-smoking patients diagnosed with Stage III Periodontitis. Gingival crevicular fluid and serum samples will be collected for biochemical analysis. | |
| Smoking Stage III Periodontitis | Patients with a history of smoking diagnosed with Stage III Periodontitis. Gingival crevicular fluid and serum samples will be collected for biochemical analysis. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Apelin, Periostin, and hs-CRP levels in Gingival Crevicular Fluid (GCF) and Serum
Measured: At baseline, At the time of sample collection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2026
- Study start7 Jan 2025
- Primary completion28 Aug 2026
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontitis (Stage 3)Studies 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
- Prospective
- Enrolment
- 85 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pamukkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aysegül Sener, Pamukkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07870473
- Sponsor's protocol ID
- 2026DİŞF003
- Other IDs
- 2026DİŞF003
- Status last verified
- Oct 2026
- First submitted
- 6 Oct 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Smoking on Apelin, Periostin, and High-Sensitivity CRP Levels in Gingival Crevicular Fluid and Serum
- ClinicalTrials.gov ID
- NCT07870473
- Acronym / sponsor ID
- 2026DİŞF003
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 85 participants (estimated)
- Lead sponsor
- Pamukkale UniversityUniversity, hospital or other
- Study start
- 7 Jan 2025 (actual)
- Primary completion
- 28 Aug 2026 (actual)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 13 Oct 2026 (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.
Periodontal health is influenced by various local and systemic factors, with smoking being one of the major environmental risk factors. This clinical study is designed to investigate the biochemical profiles of individuals by measuring apelin, periostin, and high-sensitivity C-reactive protein (hs-CRP) levels in both gingival crevicular fluid and serum. The participants will be divided into specific study groups based on their smoking status and periodontal condition. Samples of gingival crevicular fluid and serum will be collected under standard clinical protocols, and biomarker concentrations will be analyzed quantitatively using the ELISA (Enzyme-Linked Immunosorbent Assay) method to evaluate their potential correlation with periodontal status.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Non-smoking Periodontally Healthy | – | –Systemically and periodontally healthy individuals who do not smoke. Gingival crevicular fluid and serum samples will be collected from this group for biochemical analysis. |
| Smoking Periodontally Healthy | – | –Systemically healthy individuals who are periodontally healthy and have a history of smoking. Gingival crevicular fluid and serum samples will be collected from this group for biochemical analysis. |
| Non-smoking Stage III Periodontitis | – | –Non-smoking patients diagnosed with Stage III Periodontitis. Gingival crevicular fluid and serum samples will be collected for biochemical analysis. |
| Smoking Stage III Periodontitis | – | –Patients with a history of smoking diagnosed with Stage III Periodontitis. Gingival crevicular fluid and serum samples will be collected for biochemical analysis. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will comprise systemically healthy individuals and patients diagnosed with Stage III Periodontitis, categorized by their smoking status, who are admitted to the Department of Periodontology.
Key inclusion criteria (29 listed)
- Age 18 years or older.
- No history of systemic diseases that could affect periodontal status.
- Never smoked in the past 10 years.
- Probing pocket depth (PPD) ≤3 mm and no clinical attachment loss (CAL) in the sampled teeth.
- Absence of gingival inflammation and no history of periodontal disease.
Key exclusion criteria (9 listed)
- Individuals under the age of 18
- Individuals with a systemic disease
- Cancer patients and those with a history of chemotherapy or radiation therapy
- Pregnant and breastfeeding women
- People who have quit smoking
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
Apelin, Periostin, and hs-CRP levels in Gingival Crevicular Fluid (GCF) and Serum
Time frame: At baseline, At the time of sample collection
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 13 Oct 2026.
- Individual participant dataSharing planned: No
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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.
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 Periodontitis (Stage 3) and Periodontal Health, run by Pamukkale 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 29 inclusion and 9 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: under way, not looking for participants, as of the sponsor's last update on 13 Oct 2026. 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?
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?
Apelin, Periostin, and hs-CRP levels in Gingival Crevicular Fluid (GCF) and Serum (time frame: At baseline, At the time of sample collection). 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 Oct 2026.