Clinical trial NCT06627972: Asprosin Level in Individuals with Periodontal Disease
Official title: Is THERE a RELATIONSHIP BETWEEN PERIODONTAL CONDITION and ASPROSIN LEVEL in GINGIVAL CREVICULAR FLUID?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Periodontitis
Periodontal Health
Gingivitis
Keywords: gingival crevicular fluid
asprosin hormone
periodontal diseases
tumour necrosis factor alpha
Lead sponsor: Mustafa Kemal University
Sponsor class: OTHER
First posted: 2024-10-04
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The participants who applied to the Periodontology Department in Adiyaman University, Faculty of Dentistry were included in the study.

Brief 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.

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.

Eligibility criteria: Exclusion Criteria:

* 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

Primary outcomes:
measure: Asprosin level
timeFrame: Day 1
Secondary outcomes:
measure: TNF-alpha levels
timeFrame: Day 1
measure: Plaque index
timeFrame: Day 1
measure: bleeding on probing
timeFrame: Day 1
measure: probing pocket depth
timeFrame: Day 1
measure: body mass index
timeFrame: Day 1
Other outcomes:
Locations:
city: Adıyaman
country: Turkey
facility: Adiyaman University, Faculty of Dentistry
Study officials:
affiliation: Adiyaman University
name: Abdulsamet Tanık, PhD
role: STUDY_CHAIR
References:
citation: 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.
citation: Gul 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.
citation: de 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.
citation: Afacan 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.