Clinical trial NCT06250764: Asprosin, Adropin, Irisin Levels in Periodontitis
Official title: Investigation the Relationship Between Periodontal Disease and 'Asprosin, Adropin, Irisin' Levels
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Periodontal Diseases
Gingivitis
Obesity
Keywords: adropin
asprosin
irisin
periodontal disease
gingival crevicular fluid
Lead sponsor: Pamukkale University
Sponsor class: OTHER
First posted: 2024-02-09
Enrollment: 122
Sex: ALL
Minimum age (years): 25
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients admitted to the periodontology clinic between the study dates

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.

Detailed description: A total of 122 patients participated in the study. All patients participating in the trial received written and verbal information about the purpose and method of the study and signed consent. 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 Organization, and patients who refused to participate were excluded from the study. In order to calculate the BMI of the individuals included in the study, height-weight information, tooth brushing frequency in order to determine oral hygiene habits, and educational status were also recorded to determine economic levels. Age and gender were also noted. Individuals aged 25-60 years were divided into four groups according to their periodontal status.

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. To assess the intra-examiner calibration, Cronbach's alpha was used and its value was 0.90 for PD and CAL measures. Alveolar bone loss (ABL) was determined in each participant by orthopantomography. The distance between the cemento-enamel junction and the bone crest was measured in both mesial and distal regions and its ratio to the root length was calculated to assess bone loss. The periodontal status of the patients was evaluated based on the Classification of Periodontal and Peri-Implant Diseases and Conditions from the 2017 World Workshop. Participants were classified into four distinct groups based on their periodontal conditions:

1. Group 1: 30 periodontally healthy individuals;
2. Group 2: 30 patients with gingivitis;
3. Group 3: 32 patients with generalized stage I and stage II periodontitis;
4. Group 4: 30 patients with generalized stage III and stage IV periodontitis. 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. Patients with gingivitis had PD ≤3 mm, BOP in ≥30% of the probing sites, and no interproximal AL or radiographic bone loss. 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, which primarily involves horizontal bone loss. Stage II periodontitis was diagnosed with interdental attachment loss (AL) 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. Stage III periodontitis is diagnosed when interdental attachment loss (AL) is ≥ 5, radiographic bone loss (BL) extends to the mid-third of the root and beyond, and 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) of ≥ 5 mm at the site of greatest loss, with radiographic BL extending to the mid-third of the root and beyond. ≥5 tooth losses due to periodontitis are evident. In addition to Stage III, either masticatory dysfunction, secondary occlusal trauma (tooth mobility degree ≥ 2), severe ridge defect, bite collapse, or teeth drifting and flaring

Eligibility criteria: Inclusion Criteria:

All patients but exclusion criteria

Exclusion Criteria:

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

Primary outcomes:
measure: Association of PD and adipokine values
timeFrame: only baseline measurement the patients were seen once
Secondary outcomes:
Other outcomes:
Locations:
city: Adıyaman
country: Turkey
facility: Adıyaman University Faculty of Dentistry
Study officials:
affiliation: Adiyaman University
name: METİN ÇALIŞIR, PHD
role: PRINCIPAL_INVESTIGATOR
affiliation: Adiyaman University
name: Sevde DEMİRCİ
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.