Effect of Periodontal Treatment on Adipokine Levels

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06225154
• Other study ID #: SAG-C-DRP-100216-0041
• Status: Completed
• Phase: N/A
• Start date: February 2015
• Est. completion date: November 2016

Study information

• Verified date: January 2024
• Source: Marmara University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: November 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Periodontitis

Intervention

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

Locations

Country	Name	City	State
Finland	Department of Periodontology, Institute of Dentistry, Turku University	Turku	Lemminkäisenkatu 2
Turkey	Marmara University, Faculty of Dentistry, Department of Periodontology	Istanbul	Maltepe

Sponsors (2)

Lead Sponsor	Collaborator
Marmara University	University of Turku

Countries where clinical trial is conducted

Finland,  Turkey, 

References & 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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Probing Depth (mm)	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
Other	Plaque Index	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
Other	Gingival Index	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
Other	Bleeding on Probing (%)	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
Other	Clinical Attachment Level (mm)	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
Primary	Serum and Salivary Resistin Levels (pg/ml)	Serum and salivary resistin levels	Change between baseline, 1 and 3 months after non-surgical periodontal treatment
Primary	Serum and Salivary Leptin Levels (pg/ml)	Serum and salivary leptin levels	Change baseline, 1 and 3 months after non-surgical periodontal treatment
Primary	Serum and Salivary Visfatin Levels (pg/ml)	Serum and salivary visfatin levels	Change baseline, 1 and 3 months after non-surgical periodontal treatment
Primary	Serum and saliva IL-1ß levels (pg/ml)	Serum and salivary IL-1ß levels	Change baseline, 1 and 3 months after non-surgical periodontal treatment
Secondary	HbA1c ( %)	Glycated Hemoglobin Level %	Change baseline, 1 and 3 months after non-surgical periodontal treatment