PeriodontitisNCT06879951
EVALUATION of GINGIVAL CREVICULAR FLUID and SERUM ASPROSIN LEVELS in OBESE and NORMAL-WEIGHT INDIVIDUALS with PERIODONTITIS
An observational study of Periodontitis and Obesity, run by Gazi University at 1 site in Turkey (Türkiye).
Trial summary
Obesity and periodontitis are chronic inflammatory diseases that share common pathological mechanisms. Asprosin, a novel adipokine discovered in 2016, has not been extensively studied in relation to periodontal tissues. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontitis, Obesity
- What is being tested?
- Participants are not assigned an intervention as part of the study.
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 8 Aug 2023to 10 Aug 2024
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients were recruited from the Periodontology Clinic at Gazi University Faculty of Dentistry between August 2023 and August 2024. All participants who met the inclusion criteria were included in the study. Before their participation, the study's purpose and methods were explained, and written informed consent was obtained.
Who may be able to join
- Willingness to participate in the study.
- Weight classification:
- Obese individuals: Body mass index (BMI) of 30 kg/m² or higher.
- Normal-weight individuals: BMI between 18.5 and 24.9 kg/m².
- Periodontal health status:
- Bleeding on probing: less than 10%.
Show all 11Show fewer
- Periodontal pocket depth: less than 3 mm.
- No sites showing attachment loss or alveolar bone loss on radiographs.
- For individuals with periodontitis:
- At least two non-adjacent teeth must show signs of interdental attachment loss.
- Periodontal pocket depth greater than 3 mm.
Who cannot join
- Individuals who have received periodontal therapy, any oral decontamination treatment, or antibiotics or steroids in the six months prior to the start of the study.
- Individuals who are pregnant or breastfeeding.
- Individuals diagnosed with rheumatoid arthritis or lupus erythematosus.
- Individuals with a medical history of radiation or cancer therapy.
- Patients with diabetes, defined by:
- Hemoglobin A1c (HbA1c) level greater than 6.5%.
Show all 9Show fewer
- Fasting blood glucose (FBG) greater than 126 mg/dL.
- An abnormal oral glucose tolerance test (OGTT).
- Smokers.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gazi University Faculty of Dentistry
Ankara, 06490
About this study
Official title: Evaluation of Serum and Gingival Crevicular Fluid Asprosin Levels in Obese and Normal-Weight Patients with Periodontitis
Obesity and periodontitis are chronic inflammatory diseases that share common pathological mechanisms. Asprosin, a novel adipokine discovered in 2016, has not been extensively studied in relation to periodontal tissues. In our study, we investigate the levels of asprosin in both serum and gingival crevicular fluid of patients with obesity and those of normal weight who have periodontitis. Additionally, our research aims to clarify the pathophysiological mechanisms linking periodontitis and obesity by examining local and systemic levels of TNF-α, IL-6, and asprosin, alongside clinical periodontal parameters.
- Conditions
- Periodontitis, Obesity
- Being tested
- Participants are not assigned an intervention as part of the study.
- Keywords
- Periodontitis, Obesity, Asprosin, Chronic Inflammatory Diseases
- Medical subject headings
- Periodontitis, Obesity, Arachnodactyly
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Participants are not assigned an intervention as part of the study.Other
Participants are not assigned an intervention as part of the study.
| Study group | Role | What they receive |
|---|---|---|
| Obese individiuals with periodontitis | Not described Receives: Other: Participants are not assigned an intervention as part of the study. | |
| Obese individuals with periodontal healthy | Not described Receives: Other: Participants are not assigned an intervention as part of the study. | |
| Normal-weight Individuals with Periodontitis | Not described Receives: Other: Participants are not assigned an intervention as part of the study. | |
| Normal-weight Individuals with periodontal health | Not described Receives: Other: Participants are not assigned an intervention as part of the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biyomarker levels
All groups' GCF and serum levels of asprosin, TNF-α, and IL-6 levels
Measured: 08.10.2023-08.10.2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2025
- Study start8 Aug 2023
- Primary completion10 Aug 2024
- Study completion10 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PeriodontitisStudies of the same condition, open and under way.
- More trials run by Gazi 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Buse Naz BÜYÜKAKÇALI ALTAY, Gazi University
- Investigators
- Aysen Bodur, Professor, Study director, Gazi University Faculty of Dentistry Department of Periodontology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06879951
- Sponsor's protocol ID
- E-21071282-050.99-720599
- Status last verified
- Mar 2025
- First submitted
- 11 Mar 2025
- Last updated
- 17 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Altay BNB, Bodur A, Bagriacik EU, Oruklu N, Toruner FB, Sodan HN. Serum and gingival crevicular fluid asprosin levels in obese and normal-weight individuals with and without periodontitis: a cross-sectional study. BMC Oral Health. 2026 Apr 6;26(1):950. doi: 10.1186/s12903-026-08249-y.
PubMed 41942957
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Serum and Gingival Crevicular Fluid Asprosin Levels in Obese and Normal-Weight Patients with Periodontitis
- ClinicalTrials.gov ID
- NCT06879951
- Acronym / sponsor ID
- E-21071282-050.99-720599
- Conditions
- Periodontitis, Obesity
- Keywords
- Periodontitis, Obesity, Asprosin, Chronic Inflammatory Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 8 Aug 2023 (actual)
- Primary completion
- 10 Aug 2024 (actual)
- Study completion
- 10 Aug 2024 (actual)
- First posted
- 17 Mar 2025 (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.
Obesity and periodontitis are chronic inflammatory diseases that share common pathological mechanisms. Asprosin, a novel adipokine discovered in 2016, has not been extensively studied in relation to periodontal tissues. In our study, we investigate the levels of asprosin in both serum and gingival crevicular fluid of patients with obesity and those of normal weight who have periodontitis. Additionally, our research aims to clarify the pathophysiological mechanisms linking periodontitis and obesity by examining local and systemic levels of TNF-α, IL-6, and asprosin, alongside clinical periodontal parameters.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Obese individiuals with periodontitis | – | Other: Participants are not assigned an intervention as part of the study. |
| Obese individuals with periodontal healthy | – | Other: Participants are not assigned an intervention as part of the study. |
| Normal-weight Individuals with Periodontitis | – | Other: Participants are not assigned an intervention as part of the study. |
| Normal-weight Individuals with periodontal health | – | Other: Participants are not assigned an intervention as part of the study. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients were recruited from the Periodontology Clinic at Gazi University Faculty of Dentistry between August 2023 and August 2024. All participants who met the inclusion criteria were included in the study. Before their participation, the study's purpose and methods were explained, and written informed consent was obtained.
Key inclusion criteria (11 listed)
- Willingness to participate in the study.
- Weight classification:
- Periodontal health status:
- For individuals with periodontitis:
Key exclusion criteria (9 listed)
- Individuals who have received periodontal therapy, any oral decontamination treatment, or antibiotics or steroids in the six months prior to the start of the study.
- Individuals who are pregnant or breastfeeding.
- Individuals diagnosed with rheumatoid arthritis or lupus erythematosus.
- Individuals with a medical history of radiation or cancer therapy.
- Patients with diabetes, defined by:
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 |
|---|---|---|
| Participants are not assigned an intervention as part of the study.Participants are not assigned an intervention as part of the study. | Other | Normal-weight Individuals with Periodontitis, Normal-weight Individuals with periodontal health, Obese individiuals with periodontitis, Obese individuals with periodontal healthy |
Primary outcome
Biyomarker levels
Time frame: 08.10.2023-08.10.2024
All groups' GCF and serum levels of asprosin, TNF-α, and IL-6 levels
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 17 Mar 2025.
- Derived from this study: PubMed 41942957Altay BNB, Bodur A, Bagriacik EU, Oruklu N, Toruner FB, Sodan HN. Serum and gingival crevicular fluid asprosin levels in obese and normal-weight individuals with and without periodontitis: a cross-sectional study. BMC Oral Health. 2026 Apr 6;26(1):950. doi: 10.1186/s12903-026-08249-y.
- Individual participant dataSharing planned: No
Related trials for Periodontitis
Recruiting
Effect of Cryotherapeutic and Nanotherapeutic Sodium Hypochlorite on Post-Operative Endodontic Pain.
Symptomatic Irreversible Pulpitis, Symptomatic Apical Periodontitis
Active, not recruitingObservational study
A Retrospective Comparative Evaluation of Omega-3 and Resveratrol Supplementation in Patients With Periodontitis
Periodontitis
Recruiting
Probiotics Versus Antibiotics as an Adjuvant to Non-surgical Periodontal Treatment Among Smokers With Stage II, Grade B Periodontitis
Probiotics, Antibiotics
Recruiting
Effects of Different Activation Techniques on Antimicrobial Photodynamic Therapy in Apical Periodontitis
Apical Periodontitis, Endodontic Retreatment
Recruiting
Ozone Gel Versus Chlorohexidine Gel as an Adjunct to Non-Surgical Treatment of Stage II Periodontitis Grade B Among Smokers Patients
Ozone Gel, Chlorohexidine Gel
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.
Aysen Bodur, Professor study director
Gazi University Faculty of Dentistry Department of Periodontology
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 and Obesity, run by Gazi 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 11 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: finished, as of the sponsor's last update on 17 Mar 2025. 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?
Biyomarker levels (time frame: 08.10.2023-08.10.2024). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06879951, which also lists 1 linked publication.
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 17 Mar 2025.