Effect of Periodontal Treatment on Adipokine Levels

NCT06225154 | Completed DMC

• 1 other identifier: SAG-C-DRP-100216-0041
• Study Type: interventional
• Target: 80
• Locations: 2 countries
• Sites: 2

Brief Summary

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).

Conditions

Periodontitis; Diabetes Mellitus, Type 2

Keywords

adipokines; diabetes mellitus; inflammation; periodontitis

Outcome Measures

Primary Outcomes (4)

• Serum and Salivary Resistin Levels (pg/ml)

  Serum and salivary resistin levels

  Change between baseline, 1 and 3 months after non-surgical periodontal treatment

• Serum and Salivary Leptin Levels (pg/ml)

  Serum and salivary leptin levels

  Change baseline, 1 and 3 months after non-surgical periodontal treatment

• Serum and Salivary Visfatin Levels (pg/ml)

  Serum and salivary visfatin levels

  Change baseline, 1 and 3 months after non-surgical periodontal treatment

• Serum and saliva IL-1β levels (pg/ml)

  Serum and salivary IL-1β levels

  Change baseline, 1 and 3 months after non-surgical periodontal treatment

Secondary Outcomes (1)

• HbA1c ( %)

  Change baseline, 1 and 3 months after non-surgical periodontal treatment

Other Outcomes (5)

• Probing Depth (mm)

  Change baseline, 1 and 3 months after non-surgical periodontal treatment

• Plaque Index

  Change baseline, 1 and 3 months after non-surgical periodontal treatment

• Gingival Index

  Change baseline, 1 and 3 months after non-surgical periodontal treatment

Study Arms (2)

No intervention

NO INTERVENTION

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

Non-surgical periodontal treatment

EXPERIMENTAL

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.

Procedure: Non-surgical periodontal treatment

Interventions

Non-surgical periodontal treatment PROCEDURE

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

Non-surgical periodontal treatment

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Marmara University: lead
• University of Turku: collaborator

Study Sites (2)

Department of Periodontology, Institute of Dentistry, Turku University

Turku, Lemminkäisenkatu 2, FI-20520, Finland

Location

Marmara University, Faculty of Dentistry, Department of Periodontology

Istanbul, Maltepe, 34854, Turkey (Türkiye)

Location

Related Publications (3)

• 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.

  PMID: 18565135 BACKGROUND

• 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.

  PMID: 23805816 BACKGROUND

• 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.

  PMID: 25858047 BACKGROUND

MeSH Terms

Conditions

Periodontitis; Diabetes Mellitus, Type 2; Diabetes Mellitus; Inflammation

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Basak Dogan, Prof. Dr.

  Department of Periodontology, Faculty of Dentistry, Marmara University

  STUDY DIRECTOR

• Yaprak Kalkan, Dt.

  Department of Periodontology, Institute of Health Sciences, Marmara University

  PRINCIPAL INVESTIGATOR

• Ulvi Kahraman Gürsoy, Assoc. Prof.

  Department of Periodontology, Institute of Dentistry, Turku University

  STUDY CHAIR

• Mervi Gürsoy, Assoc. Prof.

  Department of Periodontology, Institute of Dentistry, Turku University

  STUDY CHAIR

• Eija Könönen, Prof. Dr.

  Department of Periodontology, Institute of Dentistry, Turku University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2018
• First Posted: January 25, 2024
• Study Start: February 1, 2015
• Primary Completion: May 1, 2016
• Study Completion: November 1, 2016
• Last Updated: January 30, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1); TU (1)