Effect of Periodontal Treatment on Adipokine Levels

NCT ID: NCT06225154

Last Updated: 2024-01-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-28

Study Completion Date

2016-11-30

Brief Summary

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The present study aimed to determine the effect of non-surgical periodontal treatment (NSPT) on serum and salivary adipokine and interleukin-1β levels in periodontitis patients with or without type 2 Diabetes Mellitus (T2DM).

Detailed Description

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The present study aimed to determine the effect of non-surgical periodontal treatment (NSPT) on serum and salivary adipokine and interleukin (IL)-1β levels in periodontitis patients with or without type 2 Diabetes Mellitus (T2DM). A total of 80 patients; 20 healthy, 20 T2DM with periodontitis (P), 20 T2DM periodontally healthy, 20 systemically healthy with P were included in this study. At baseline, serum and saliva samples were collected and the whole mouth clinical periodontal parameters were recorded. Periodontitis patients received NSPT in 4 sessions. Clinical parameters were re-measured and samples were re-collected at 1 and 3 months after treatment. Serum and salivary levels of adipokines and IL-1β were analyzed using a flow cytometry-based technique of Lumina® map™. Data were analyzed using appropriate statistical tests.

Conditions

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Periodontitis Diabetes Mellitus, Type 2

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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No intervention

Periodontally healthy subjects with type 2 diabetes mellitus or systemically healthy didn't have an initial periodontal treatment

Group Type NO_INTERVENTION

No interventions assigned to this group

Non-surgical periodontal treatment

Non-surgical periodontal treatment was performed in a quadrant-wise manner at 1-week intervals for periodontitis patients systemically healthy or with type 2 diabetes mellitus.

Group Type EXPERIMENTAL

Non-surgical periodontal treatment

Intervention Type PROCEDURE

Non-surgical periodontal treatment was performed in a quadrant-wise manner at 1-week intervals.

Interventions

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Non-surgical periodontal treatment

Non-surgical periodontal treatment was performed in a quadrant-wise manner at 1-week intervals.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Diabetes mellitus should be diagnosed for ≥1 year and HbA1c level should be at least %6,5
* Periodontitis should be diagnosed for at least 4 teeth with probing depth ≥5 mm with bleeding on probing (BOP) and also radiographic alveolar bone loss should be presence
* Presence of at least 15 teeth

Exclusion Criteria

* Received antibiotic treatment in the previous 3 months
* Smokers
* Pregnancy and lactation
* Received periodontal treatment in the previous 6 months
* Presence of less than 15 teeth
* Having major diabetic complications
Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Turku

OTHER

Sponsor Role collaborator

Marmara University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Basak Dogan, Prof. Dr.

Role: STUDY_DIRECTOR

Department of Periodontology, Faculty of Dentistry, Marmara University

Yaprak Kalkan, Dt.

Role: PRINCIPAL_INVESTIGATOR

Department of Periodontology, Institute of Health Sciences, Marmara University

Ulvi Kahraman Gürsoy, Assoc. Prof.

Role: STUDY_CHAIR

Department of Periodontology, Institute of Dentistry, Turku University

Mervi Gürsoy, Assoc. Prof.

Role: STUDY_CHAIR

Department of Periodontology, Institute of Dentistry, Turku University

Eija Könönen, Prof. Dr.

Role: STUDY_CHAIR

Department of Periodontology, Institute of Dentistry, Turku University

Locations

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Department of Periodontology, Institute of Dentistry, Turku University

Turku, Lemminkäisenkatu 2, Finland

Site Status

Marmara University, Faculty of Dentistry, Department of Periodontology

Istanbul, Maltepe, Turkey (Türkiye)

Site Status

Countries

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Finland Turkey (Türkiye)

References

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Furugen R, Hayashida H, Yamaguchi N, Yoshihara A, Ogawa H, Miyazaki H, Saito T. The relationship between periodontal condition and serum levels of resistin and adiponectin in elderly Japanese. J Periodontal Res. 2008 Oct;43(5):556-62. doi: 10.1111/j.1600-0765.2008.01085.x. Epub 2008 Jun 28.

Reference Type BACKGROUND
PMID: 18565135 (View on PubMed)

Gokhale NH, Acharya AB, Patil VS, Trivedi DJ, Setty S, Thakur SL. Resistin levels in gingival crevicular fluid of patients with chronic periodontitis and type 2 diabetes mellitus. J Periodontol. 2014 Apr;85(4):610-7. doi: 10.1902/jop.2013.130092. Epub 2013 Jun 27.

Reference Type BACKGROUND
PMID: 23805816 (View on PubMed)

Goncalves TE, Zimmermann GS, Figueiredo LC, Souza Mde C, da Cruz DF, Bastos MF, da Silva HD, Duarte PM. Local and serum levels of adipokines in patients with obesity after periodontal therapy: one-year follow-up. J Clin Periodontol. 2015 May;42(5):431-9. doi: 10.1111/jcpe.12396. Epub 2015 Apr 30.

Reference Type BACKGROUND
PMID: 25858047 (View on PubMed)

Other Identifiers

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SAG-C-DRP-100216-0041

Identifier Type: -

Identifier Source: org_study_id

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