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NCT Number: NCT06225154

Effect of Periodontal Treatment on Adipokine Levels

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).

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Key information

Conditions

Periodontitis Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Inflammation Metabolic Diseases Mouth Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Periodontal Diseases Stomatognathic Diseases

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Periodontology, Institute of Dentistry, Turku University, Turku, Lemminkäisenkatu 2, Finland

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Non-surgical periodontal treatment

Procedure

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

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

Secondary outcomes

  1. HbA1c ( %)

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

    Glycated Hemoglobin Level %

Other outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Sponsors and collaborators

Lead sponsor

Marmara University

Other

Collaborators

  • University of Turku

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jan 25, 2024
Registry last updated
Jan 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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