Effect of Periodontal Treatment on Adipokine Levels

January 27, 2024 updated by: Marmara University

Effect of Non-Surgical Periodontal Treatment on Adipokine Levels in Diabetes Mellitus: A Controlled Clinical Trial

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
    • Lemminkäisenkatu 2
      • Turku, Lemminkäisenkatu 2, Finland, FI-20520
        • Department of Periodontology, Institute of Dentistry, Turku University
  • Turkey
    • Maltepe
      • İstanbul, Maltepe, Turkey, 34854
        • Marmara University, Faculty of Dentistry, Department of Periodontology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: No intervention
Periodontally healthy subjects with type 2 diabetes mellitus or systemically healthy didn't have an initial periodontal treatment
Experimental: 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.
Procedure: Non-surgical periodontal treatment
Non-surgical periodontal treatment was performed in a quadrant-wise manner at 1-week intervals.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serum and Salivary Resistin Levels (pg/ml)
Time Frame: Change between baseline, 1 and 3 months after non-surgical periodontal treatment
Serum and salivary resistin levels
Change between baseline, 1 and 3 months after non-surgical periodontal treatment
Serum and Salivary Leptin Levels (pg/ml)
Time Frame: Change baseline, 1 and 3 months after non-surgical periodontal treatment
Serum and salivary leptin levels
Change baseline, 1 and 3 months after non-surgical periodontal treatment
Serum and Salivary Visfatin Levels (pg/ml)
Time Frame: Change baseline, 1 and 3 months after non-surgical periodontal treatment
Serum and salivary visfatin levels
Change baseline, 1 and 3 months after non-surgical periodontal treatment
Serum and saliva IL-1β levels (pg/ml)
Time Frame: Change baseline, 1 and 3 months after non-surgical periodontal treatment
Serum and salivary IL-1β levels
Change baseline, 1 and 3 months after non-surgical periodontal treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HbA1c ( %)
Time Frame: Change baseline, 1 and 3 months after non-surgical periodontal treatment
Glycated Hemoglobin Level %
Change baseline, 1 and 3 months after non-surgical periodontal treatment

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Probing Depth (mm)
Time Frame: Change baseline, 1 and 3 months after non-surgical periodontal treatment
probing depth measured from the gingival margin seldom corresponds to sulcus or pocket depth in mm.
Change baseline, 1 and 3 months after non-surgical periodontal treatment
Bleeding on Probing (%)
Time Frame: Change baseline, 1 and 3 months after non-surgical periodontal treatment
Percentage of bleeding sites. Bleeding on probing, often abbreviated BOP, is a sign of inflammation and indicates some sort of destruction and erosion to the lining of the sulcus or the ulceration of sulcular epithelium. The blood comes from lamina propria after the ulceration of the lining.
Change baseline, 1 and 3 months after non-surgical periodontal treatment
Clinical Attachment Level (mm)
Time Frame: Change baseline, 1 and 3 months after non-surgical periodontal treatment
The estimated position of structures that support the tooth as measured with a periodontal probe in mm; provides an estimate of a tooth's stability and of loss of bone support.
Change baseline, 1 and 3 months after non-surgical periodontal treatment
Plaque Index
Time Frame: Change baseline, 1 and 3 months after non-surgical periodontal treatment
The measurement of the state of oral hygiene by Silness-Löe plaque index is based on recording both soft debris and mineralized deposits on the following teeth. Values 0,1,2 and 3 can be taken. While 0 indicates the least value, 3 indicates the maximum value.
Change baseline, 1 and 3 months after non-surgical periodontal treatment
Gingival Index
Time Frame: Change baseline, 1 and 3 months after non-surgical periodontal treatment
A measure of periodontal disease based on the severity and location of the lesion. Values 0,1,2 and 3 can be taken. While 0 indicates the least value, 3 indicates the maximum value.
Change baseline, 1 and 3 months after non-surgical periodontal treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Marmara University

Collaborators

University of Turku

Investigators

  • Study Director: Basak Dogan, Prof. Dr., Department of Periodontology, Faculty of Dentistry, Marmara University
  • Principal Investigator: Yaprak Kalkan, Dt., Department of Periodontology, Institute of Health Sciences, Marmara University
  • Study Chair: 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2015

Primary Completion (Actual)

May 1, 2016

Study Completion (Actual)

November 1, 2016

Study Registration Dates

First Submitted

February 1, 2018

First Submitted That Met QC Criteria

January 16, 2024

First Posted (Actual)

January 25, 2024

Study Record Updates

Last Update Posted (Actual)

January 30, 2024

Last Update Submitted That Met QC Criteria

January 27, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SAG-C-DRP-100216-0041

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Diabetes Mellitus, Type 2

Clinical Trials on Non-surgical periodontal treatment

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Russia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe