Effect of Periodontal Treatment on Adipokine Levels

Not Applicable

Completed

• Conditions: Periodontitis; Diabetes Mellitus, Type 2
• Interventions: Procedure: Non-surgical periodontal treatment

• Registration Number: NCT06225154
• Lead Sponsor: Marmara University

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).

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 Timeline

• Study Start: 2015-02
• Primary Completion: 2016-05
• Study Completion: 2016-11
• Study First Submitted: 2018-02-01
• Status Verified: 2024-01
• Study First Submitted QC: 2024-01-16
• Study First Posted: 2024-01-25
• Last Update Submitted: 2024-01-27
• Last Update Posted: 2024-01-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Non-surgical periodontal treatment	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
HbA1c ( %)	Change baseline, 1 and 3 months after non-surgical periodontal treatment	Glycated Hemoglobin Level %

Trial Locations

Locations (2)

Department of Periodontology, Institute of Dentistry, Turku University; 🇫🇮 Turku, Lemminkäisenkatu 2, Finland

Marmara University, Faculty of Dentistry, Department of Periodontology; 🇹🇷 İstanbul, Maltepe, Turkey