NCT06250764

Brief Summary

The recently discovered association of the hormones 'asprosin, adropin and irisin' with obesity and metabolic status, as well as the fact that periodontal diseases are affected by obesity and nutrition bilaterally, have led us to investigate the relationship between selected target markers and periodontal disease. The primary aim and main objective of this study is to increase the knowledge and to direct future researches as a result of the lack of adequate research in the past and the very limited investigations with these hormones in dentistry and periodontology. Our study was conducted on 122 patients who applied to Adıyaman University Faculty of Dentistry and were referred to the Department of Periodontology for routine periodontal controls. Participants' gender, age, height, weight, BMI, education level, tooth brushing and flossing habits as well as clinical parameters PI, GI, SCD, CAS and SDI were noted. Participants were divided into 4 groups as healthy, gingivitis, initial periodontitis and advanced periodontitis and grouped according to the current periodontal classification of 2017. DOS was collected from the groups for examination and 'asprosin, adropin and irisin' values in the samples were evaluated by ELISA test.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
122

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2020

Typical duration 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

February 12, 2020

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 23, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 23, 2022

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

February 1, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 9, 2024

Completed
Last Updated

February 9, 2024

Status Verified

February 1, 2024

Enrollment Period

2 years

First QC Date

February 1, 2024

Last Update Submit

February 1, 2024

Conditions

Keywords

adropinasprosinirisinperiodontal diseasegingival crevicular fluid

Outcome Measures

Primary Outcomes (1)

  • Association of PD and adipokine values

    correlation identification using SPSS between pocket depth and these adipokines in periodontitis patients

    only baseline measurement the patients were seen once

Study Arms (4)

GROUP 1 (periodontally healthy )

An individual to be considered to have periodontal health according to this definition, the percentage of sites with bleeding on probing should be no more than 10%, and the probing depth should be 3 mm or less

Diagnostic Test: Clinical periodontal measuremenetsDiagnostic Test: ELISA test from gingival crevicular fluid (GCF)

GROUP 2 (gingivitis)

Patients with gingivitis had PD ≤3 mm, BOP in ≥30% of the probing sites, and no interproximal AL or radiographic bone loss

Diagnostic Test: Clinical periodontal measuremenetsDiagnostic Test: ELISA test from gingival crevicular fluid (GCF)

GROUP 3(generalized stage I and stage II periodontitis)

Stage I periodontitis was diagnosed with interdental attachment loss (AL) ranging between 1 and 2 mm at the site of greatest loss. Radiographic bone loss (BL) is limited to less than 15% and no tooth loss. Additionally, the maximum probing depth (PD) is equal to or less than 4 mm or primarily involves horizontal bone loss. Stage II periodontitis was diagnosed with interdental attachment loss (AL) is ranging between 3 and 4 mm at the site of greatest loss. Radiographic bone loss (BL) extends to a range of 15% to 33%, there is no tooth loss. The maximum probing depth (PD) is equal to or less than 5 mm or primarily involves horizontal bone loss.

Diagnostic Test: Clinical periodontal measuremenetsDiagnostic Test: ELISA test from gingival crevicular fluid (GCF)

GROUP 4 (generalized stage III and stage IV periodontitis)

Stage III periodontitis is diagnosed with interdental attachment loss (AL) is ≥ 5, radiographic bone loss (BL) extends to mid-third of the root and beyond, tooth loss may become evident ≤4 teeth. Either PD ≥ 6 mm or vertical BL ≥ 3 mm, or Class II/III furcation involvement, or moderate ridge defect. Stage IV periodontitis is diagnosed with interdental attachment loss (AL) is ≥ 5 mm at the site of greatest loss, radiographic BL extending to mid-third of the root and beyond. ≥5 tooth loss due to periodontitis is evident. In addition to Stage III, either masticatory dysfunction, or secondary occlusal trauma (tooth mobility degree ≥ 2), or severe ridge defect, or bite collapse, or teeth drifting and flaring

Diagnostic Test: Clinical periodontal measuremenetsDiagnostic Test: ELISA test from gingival crevicular fluid (GCF)

Interventions

The periodontal assessment was performed by a single trained examiner (S.D.). A graded periodontal probe (Williams, Hu-Friedy, Chicago, IL, USA) was used to measure probing depth (PD) which was determined as the depth from the gingival margin to the bottom of the gingival sulcus/periodontal pocket, clinical attachment loss (CAL) which was calculated as the distance from the cemento-enamel junction to the bottom of the periodontal pocket and dual recording (+/-) of bleeding on probing (BOP), gingival index (GI) and plaque index (PI) in total except third molars G

GROUP 1 (periodontally healthy )GROUP 2 (gingivitis)GROUP 3(generalized stage I and stage II periodontitis)GROUP 4 (generalized stage III and stage IV periodontitis)

GCF sampled from the buccal aspects of non-contiguous proximal regions in maxillary single-rooted teeth. In the periodontitis groups, fluid samples were taken from the two deepest pockets. In the gingivitis and periodontal healthy groups, fluid samples were obtained from areas with and without visible inflammation, respectively

GROUP 1 (periodontally healthy )GROUP 2 (gingivitis)GROUP 3(generalized stage I and stage II periodontitis)GROUP 4 (generalized stage III and stage IV periodontitis)

Eligibility Criteria

Age25 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

All patients admitted to the periodontology clinic between the study dates

You may not qualify if:

  • Patients with cardiovascular disease, liver and kidney disease, metabolic disorders, diabetes, asthma, thyroid dysfunction, who used antibiotics or anti-inflammatory drugs within the last three months, who received periodontal treatment within the last six months, obese patients with body mass index (BMI) ≥ 30 kg/m2 according to the reference range determined by the World Health Organisation, and patients who refused to participate were excluded from the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Adıyaman University Faculty of Dentistry

Adıyaman, Turkey (Türkiye)

Location

Related Publications (2)

  • Loesche WJ, Grossman NS. Periodontal disease as a specific, albeit chronic, infection: diagnosis and treatment. Clin Microbiol Rev. 2001 Oct;14(4):727-52, table of contents. doi: 10.1128/CMR.14.4.727-752.2001.

    PMID: 11585783BACKGROUND
  • Torumtay Cin G, Fenkci SM, Kilic ID, Aslan HS, Sevgican CI, Senol H. The effects of severe periodontitis on arterial stiffness using cardio-ankle vascular index in patients with type 2 diabetes. J Periodontal Res. 2024 Feb;59(1):74-83. doi: 10.1111/jre.13202. Epub 2023 Nov 1.

    PMID: 37909328BACKGROUND

MeSH Terms

Conditions

Periodontal DiseasesGingivitisObesityArachnodactyly

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic DiseasesInfectionsGingival DiseasesOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsLimb Deformities, CongenitalMusculoskeletal AbnormalitiesMusculoskeletal DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • METİN ÇALIŞIR, PHD

    Adiyaman University

    PRINCIPAL INVESTIGATOR
  • Sevde DEMİRCİ

    Adiyaman University

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Target Duration
3 Days
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

February 1, 2024

First Posted

February 9, 2024

Study Start

February 12, 2020

Primary Completion

February 23, 2022

Study Completion

February 23, 2022

Last Updated

February 9, 2024

Record last verified: 2024-02

Locations