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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Marmara University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Turku

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 1, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 16, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 25, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 30, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 27, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

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