Clinical trial NCT06225154: Effect of Periodontal Treatment on Adipokine Levels
Official title: Effect of Non-Surgical Periodontal Treatment on Adipokine Levels in Diabetes Mellitus: A Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Periodontitis
Diabetes Mellitus, Type 2
Keywords: adipokines
diabetes mellitus
inflammation
periodontitis
Lead sponsor: Marmara University
Sponsor class: OTHER
Collaborators: name: University of Turku
First posted: 2024-01-25
Enrollment: 80
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Serum and Salivary Resistin Levels (pg/ml)
timeFrame: Change between baseline, 1 and 3 months after non-surgical periodontal treatment
measure: Serum and Salivary Leptin Levels (pg/ml)
timeFrame: Change baseline, 1 and 3 months after non-surgical periodontal treatment
measure: Serum and Salivary Visfatin Levels (pg/ml)
timeFrame: Change baseline, 1 and 3 months after non-surgical periodontal treatment
measure: Serum and saliva IL-1β levels (pg/ml)
timeFrame: Change baseline, 1 and 3 months after non-surgical periodontal treatment
Secondary outcomes:
measure: HbA1c ( %)
timeFrame: Change baseline, 1 and 3 months after non-surgical periodontal treatment
Other outcomes:
measure: Probing Depth (mm)
timeFrame: Change baseline, 1 and 3 months after non-surgical periodontal treatment
measure: Plaque Index
timeFrame: Change baseline, 1 and 3 months after non-surgical periodontal treatment
measure: Gingival Index
timeFrame: Change baseline, 1 and 3 months after non-surgical periodontal treatment
measure: Bleeding on Probing (%)
timeFrame: Change baseline, 1 and 3 months after non-surgical periodontal treatment
measure: Clinical Attachment Level (mm)
timeFrame: Change baseline, 1 and 3 months after non-surgical periodontal treatment
Locations:
city: Turku
country: Finland
facility: Department of Periodontology, Institute of Dentistry, Turku University
state: Lemminkäisenkatu 2
city: İstanbul
country: Turkey
facility: Marmara University, Faculty of Dentistry, Department of Periodontology
state: Maltepe
Study officials:
affiliation: Department of Periodontology, Faculty of Dentistry, Marmara University
name: Basak Dogan, Prof. Dr.
role: STUDY_DIRECTOR
affiliation: Department of Periodontology, Institute of Health Sciences, Marmara University
name: Yaprak Kalkan, Dt.
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Periodontology, Institute of Dentistry, Turku University
name: Ulvi Kahraman Gürsoy, Assoc. Prof.
role: STUDY_CHAIR
affiliation: Department of Periodontology, Institute of Dentistry, Turku University
name: Mervi Gürsoy, Assoc. Prof.
role: STUDY_CHAIR
affiliation: Department of Periodontology, Institute of Dentistry, Turku University
name: Eija Könönen, Prof. Dr.
role: STUDY_CHAIR
References:
citation: 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.
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.
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.