PeriodontitisALIGCFNCT06627972
Asprosin Level in Individuals With Periodontal Disease
An observational study of Periodontitis and Periodontal Health, run by Mustafa Kemal University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study was to investigate the levels of asprosin hormone and tumour necrosis factor alpha (TNF-α) in gingival crevicular fluids and to compare its level with those in saliva and serum in patients with gingivitis and periodontitis. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontitis, Periodontal Health, Gingivitis
- How many people
- 75 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2022to 31 Aug 2022
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: The participants who applied to the Periodontology Department in Adiyaman University, Faculty of Dentistry were included in the study.
Who may be able to join
None listed.
Who cannot join
- Those with any systemic disease
- Individuals who take medication regularly
- Pregnant or lactating women
- Individuals with menopause and anthropause
- Those who have undergone any periodontal treatment in the last six months
- Smokers
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Adiyaman University, Faculty of Dentistry
Adıyaman
About this study
Official title: IS THERE A RELATIONSHIP BETWEEN PERIODONTAL CONDITION AND ASPROSIN LEVEL IN GINGIVAL CREVICULAR FLUID?
The aim of this study was to investigate the levels of asprosin hormone and tumour necrosis factor alpha (TNF-α) in gingival crevicular fluids and to compare its level with those in saliva and serum in patients with gingivitis and periodontitis.
Read the detailed description
This study is investigating the level of asprosin hormone in gingival crevicular fluid of patients with periodontal diseases such as gingivitis and periodontitis, and observing the healthy patient in terms of the hormone levels, as well. 75 volunteer patients aged 18-45 years old were included in this study. These patients were divided equally to three groups: Group I; periodontal health, Group II; gingivitis, Group III; periodontitis.The body fluids including serum, saliva and gingival crevicular fluid were collected from this participants according to the proper protocol and their storage was provided under certain conditions. ELISA tests for asprosin and Tumour necrosis factor alpha were made in laboratory. Also, clinical measurements such as plaque index, bleeding on probing, probing pocket depth were recorded at first visit day of the participants. The data were analysed according to the different periodontal conditions, and correlated with asprosin hormone and tumour necrosis factor alpha level in gingival crevicular fluid, serum and saliva.
- Conditions
- Periodontitis, Periodontal Health, Gingivitis
- Keywords
- gingival crevicular fluid, asprosin hormone, periodontal diseases, tumour necrosis factor alpha
- Medical subject headings
- Periodontitis, Gingivitis, Periodontal Diseases
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 |
|---|---|---|
| periodontal health group | Periodontal parameters were recorded at first visit and the fluid samples were collected from participants. | |
| Gingivitis group | Periodontal parameters were recorded at first visit and the fluid samples were collected from participants. | |
| periodontitis group | Periodontal parameters were recorded at first visit and the fluid samples were collected from participants. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Asprosin level
Asprosin level (ng/mL) in gingival crevicular fluid, serum and saliva.
Measured: Day 1
Secondary outcomes (5)
TNF-alpha levels
TNF-alpha level (pg/mL) in gingival crevicular fluid, serum and saliva
Measured: Day 1
Plaque index
The index was recorded from all participants as numerical between 0-3
Measured: Day 1
bleeding on probing
The bleeding on probing is stated by percentage. the ratio of the number of sites with bleeding gingiva on probing around teeth to total surfaces of all examined teeth
Measured: Day 1
probing pocket depth
The parameters were recorded as mm in all participant. The probing pocket depth is measured from the marginal gingiva to bottom of pocket using a periodontal probe, from six surfaces of each tooth.
Measured: Day 1
body mass index
the weight and height is combined to report BMI in kg/m2
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2024
- Study start1 Jan 2022
- Primary completion31 Jul 2022
- Study completion31 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for PeriodontitisStudies 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
- Cross-sectional
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mustafa Kemal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Osman Fatih Arpag, Mustafa Kemal University
- Investigators
- Abdulsamet Tanık, PhD, Study chair, Adiyaman University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06627972
- Sponsor's protocol ID
- DHFDUP/2022-0002
- Acronym
- ALIGCF
- Status last verified
- Oct 2024
- First submitted
- 1 Oct 2024
- Last updated
- 4 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Shojaee M, Fereydooni Golpasha M, Maliji G, Bijani A, Aghajanpour Mir SM, Mousavi Kani SN. C - reactive protein levels in patients with periodontal disease and normal subjects. Int J Mol Cell Med. 2013 Summer;2(3):151-5.
PubMed 24551806Gul SNS, Eminoglu DO, Laloglu E, Aydin T, Dilsiz A. Salivary and serum asprosin hormone levels in the 2018 EFP/AAP classification of periodontitis stages and body mass index status: a case-control study. Clin Oral Investig. 2024 Jan 13;28(1):91. doi: 10.1007/s00784-024-05494-9.
PubMed 38217801de Molon RS, Rossa C Jr, Thurlings RM, Cirelli JA, Koenders MI. Linkage of Periodontitis and Rheumatoid Arthritis: Current Evidence and Potential Biological Interactions. Int J Mol Sci. 2019 Sep 13;20(18):4541. doi: 10.3390/ijms20184541.
PubMed 31540277Afacan B, Ozturk VO, Pasali C, Bozkurt E, Kose T, Emingil G. Gingival crevicular fluid and salivary HIF-1alpha, VEGF, and TNF-alpha levels in periodontal health and disease. J Periodontol. 2019 Jul;90(7):788-797. doi: 10.1002/JPER.18-0412. Epub 2018 Dec 11.
PubMed 30536725Tutus S, Tanik A, Arpag OF, Onderci M. Is there a relationship between periodontal conditions and asprosin levels in gingival crevicular fluid, saliva and serum? BMC Oral Health. 2025 Apr 29;25(1):651. doi: 10.1186/s12903-025-06014-1.
PubMed 40301876
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IS THERE A RELATIONSHIP BETWEEN PERIODONTAL CONDITION AND ASPROSIN LEVEL IN GINGIVAL CREVICULAR FLUID?
- ClinicalTrials.gov ID
- NCT06627972
- Acronym / sponsor ID
- ALIGCF / DHFDUP/2022-0002
- Conditions
- Periodontitis, Periodontal Health, Gingivitis
- Keywords
- gingival crevicular fluid, asprosin hormone, periodontal diseases, tumour necrosis factor alpha
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Mustafa Kemal UniversityUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 31 Jul 2022 (actual)
- Study completion
- 31 Aug 2022 (actual)
- First posted
- 4 Oct 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 aim of this study was to investigate the levels of asprosin hormone and tumour necrosis factor alpha (TNF-α) in gingival crevicular fluids and to compare its level with those in saliva and serum in patients with gingivitis and periodontitis.
Detailed description
This study is investigating the level of asprosin hormone in gingival crevicular fluid of patients with periodontal diseases such as gingivitis and periodontitis, and observing the healthy patient in terms of the hormone levels, as well. 75 volunteer patients aged 18-45 years old were included in this study. These patients were divided equally to three groups: Group I; periodontal health, Group II; gingivitis, Group III; periodontitis.The body fluids including serum, saliva and gingival crevicular fluid were collected from this participants according to the proper protocol and their storage was provided under certain conditions. ELISA tests for asprosin and Tumour necrosis factor alpha were made in laboratory. Also, clinical measurements such as plaque index, bleeding on probing, probing pocket depth were recorded at first visit day of the participants. The data were analysed according to the different periodontal conditions, and correlated with asprosin hormone and tumour necrosis factor alpha level in gingival crevicular fluid, serum and saliva.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| periodontal health group | – | –Periodontal parameters were recorded at first visit and the fluid samples were collected from participants. |
| Gingivitis group | – | –Periodontal parameters were recorded at first visit and the fluid samples were collected from participants. |
| periodontitis group | – | –Periodontal parameters were recorded at first visit and the fluid samples were collected from participants. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The participants who applied to the Periodontology Department in Adiyaman University, Faculty of Dentistry were included in the study.
Key inclusion criteria (0 listed)
Key exclusion criteria (6 listed)
- Those with any systemic disease
- Individuals who take medication regularly
- Pregnant or lactating women
- Individuals with menopause and anthropause
- Those who have undergone any periodontal treatment in the last six months
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
Asprosin level
Time frame: Day 1
Asprosin level (ng/mL) in gingival crevicular fluid, serum and saliva.
5 secondary outcomes
TNF-alpha levels
Time frame: Day 1
Plaque index
Time frame: Day 1
bleeding on probing
Time frame: Day 1
probing pocket depth
Time frame: Day 1
body mass index
Time frame: Day 1
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 2024.
- Results publication: PubMed 24551806Shojaee M, Fereydooni Golpasha M, Maliji G, Bijani A, Aghajanpour Mir SM, Mousavi Kani SN. C - reactive protein levels in patients with periodontal disease and normal subjects. Int J Mol Cell Med. 2013 Summer;2(3):151-5.
- Results publication: PubMed 38217801Gul SNS, Eminoglu DO, Laloglu E, Aydin T, Dilsiz A. Salivary and serum asprosin hormone levels in the 2018 EFP/AAP classification of periodontitis stages and body mass index status: a case-control study. Clin Oral Investig. 2024 Jan 13;28(1):91. doi: 10.1007/s00784-024-05494-9.
- Results publication: PubMed 31540277de Molon RS, Rossa C Jr, Thurlings RM, Cirelli JA, Koenders MI. Linkage of Periodontitis and Rheumatoid Arthritis: Current Evidence and Potential Biological Interactions. Int J Mol Sci. 2019 Sep 13;20(18):4541. doi: 10.3390/ijms20184541.
- Results publication: PubMed 30536725Afacan B, Ozturk VO, Pasali C, Bozkurt E, Kose T, Emingil G. Gingival crevicular fluid and salivary HIF-1alpha, VEGF, and TNF-alpha levels in periodontal health and disease. J Periodontol. 2019 Jul;90(7):788-797. doi: 10.1002/JPER.18-0412. Epub 2018 Dec 11.
- Derived from this study: PubMed 40301876Tutus S, Tanik A, Arpag OF, Onderci M. Is there a relationship between periodontal conditions and asprosin levels in gingival crevicular fluid, saliva and serum? BMC Oral Health. 2025 Apr 29;25(1):651. doi: 10.1186/s12903-025-06014-1.
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.
Abdulsamet Tanık, PhD study chair
Adiyaman University
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 Periodontal Health, run by Mustafa Kemal 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 0 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 4 Oct 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?
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?
Asprosin level (time frame: Day 1). 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 NCT06627972, which also lists 5 linked publications.
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 2024.