NCT06627972

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2022

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

October 1, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 4, 2024

Completed
Last Updated

October 4, 2024

Status Verified

October 1, 2024

Enrollment Period

7 months

First QC Date

October 1, 2024

Last Update Submit

October 3, 2024

Conditions

PeriodontitisPeriodontal HealthGingivitis

Keywords

gingival crevicular fluidasprosin hormoneperiodontal diseasestumour necrosis factor alpha

Outcome Measures

Primary Outcomes (1)

  • Asprosin level

    Asprosin level (ng/mL) in gingival crevicular fluid, serum and saliva.

    Day 1

Secondary Outcomes (5)

  • TNF-alpha levels

    Day 1

  • Plaque index

    Day 1

  • bleeding on probing

    Day 1

  • probing pocket depth

    Day 1

  • body mass index

    Day 1

Study Arms (3)

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.

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

The participants who applied to the Periodontology Department in Adiyaman University, Faculty of Dentistry were included in the study.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Adiyaman University, Faculty of Dentistry

Adıyaman, Turkey (Türkiye)

Location

Related Publications (5)

  • 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.

    PMID: 24551806BACKGROUND

  • 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.

    PMID: 38217801BACKGROUND

  • 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.

    PMID: 31540277BACKGROUND

  • 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.

    PMID: 30536725BACKGROUND

  • Tutus 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.

    PMID: 40301876DERIVED

MeSH Terms

Conditions

PeriodontitisGingivitisPeriodontal Diseases

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic DiseasesInfectionsGingival Diseases

Study Officials

  • Abdulsamet Tanık, PhD

    Adiyaman University

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

October 1, 2024

First Posted

October 4, 2024

Study Start

January 1, 2022

Primary Completion

July 31, 2022

Study Completion

August 31, 2022

Last Updated

October 4, 2024

Record last verified: 2024-10

Locations

TU(1)