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Periodontal DiseasesNCT06250764

Asprosin, Adropin, Irisin Levels in Periodontitis

An observational study of Periodontal Diseases and Gingivitis, run by AYSAN LEKTEMUR ALPAN at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 25 to 60 yearsHealthy volunteers can take part
Conditions the study is for
Periodontal Diseases, Gingivitis, Obesity
What is being tested?
Clinical periodontal measuremenets and ELISA test from gingival crevicular fluid (GCF)
Type of treatment
Injection or infusion
How many people
122 participants
Where
1 siteTurkey (Türkiye)
Study dates
12 Feb 2020to 23 Feb 2022
How long will I take part?
3 Days
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 25 to 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Study population: All patients admitted to the periodontology clinic between the study dates

Who may be able to join

  • All patients but exclusion criteria

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Adıyaman University Faculty of Dentistry

    Adıyaman

Other trials in Turkey (Türkiye)

About this study

Official title: Investigation the Relationship Between Periodontal Disease and 'Asprosin, Adropin, Irisin' Levels

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.

Read the 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
Being tested
Clinical periodontal measuremenets, ELISA test from gingival crevicular fluid (GCF)
Keywords
adropin, asprosin, irisin, periodontal disease, gingival crevicular fluid
Medical subject headings
Periodontal Diseases, Gingivitis, Obesity, Arachnodactyly

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Clinical periodontal measuremenetsDiagnostic test

    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

  • ELISA test from gingival crevicular fluid (GCF)Diagnostic test

    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

Study groups in NCT06250764
Study groupRoleWhat they receive
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
Receives: Diagnostic Test: Clinical periodontal measuremenets; Diagnostic 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
Receives: Diagnostic Test: Clinical periodontal measuremenets; Diagnostic 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.
Receives: Diagnostic Test: Clinical periodontal measuremenets; Diagnostic 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
Receives: Diagnostic Test: Clinical periodontal measuremenets; Diagnostic Test: ELISA test from gingival crevicular fluid (GCF)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Association of PD and adipokine values

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

    Measured: only baseline measurement the patients were seen once

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Feb 2024
  2. Study start12 Feb 2020
  3. Primary completion23 Feb 2022
  4. Study completion23 Feb 2022

Resources

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
122 participants (actual)
Target duration
3 Days
IDs, dates and publications
ClinicalTrials.gov ID
NCT06250764
Sponsor's protocol ID
2020/9-10
Status last verified
Feb 2024
First submitted
1 Feb 2024
Last updated
9 Feb 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 11585783
  • 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.

    PubMed 37909328

Questions about this trial

What is this clinical trial studying?

An observational study of Periodontal Diseases and Gingivitis, run by AYSAN LEKTEMUR ALPAN 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 1 inclusion and 1 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 9 Feb 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?

Association of PD and adipokine values (time frame: only baseline measurement the patients were seen once). 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 NCT06250764, which also lists 2 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 9 Feb 2024.

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