Clinical trial NCT05662475: Effect of Periodontal Treatment on Visfatin, fetuin-a and Sirtuin 1 of Patients With Periodontitis and Type 2 Diabetes
Official title: Effect of Non-surgical Periodontal Treatment on Visfatin, fetuin-a and Sirtuin 1 Concentrations in Gingival Crevicular Fluid of Patients With Periodontitis and Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Periodontal Diseases
Type 2 Diabetes
Periodontitis
Keywords: visfatin
fetuin-A
sirtuin 1
periodontitis
type 2 diabetes
non-surgical periodontal treatment
gingival crevicular fluid
Lead sponsor: Ondokuz Mayıs University
Sponsor class: OTHER
First posted: 2022-12-22
Enrollment: 66
Sex: ALL
Minimum age (years): 31
Maximum age (years): 81
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Sixty-six patients were randomly divided into six equal groups; group 1: systemically and periodontally healthy individuals, group 2: systemically healthy individuals with periodontitis, group 3: controlled type 2 diabetes and periodontally healthy individuals, group 4: controlled type 2 diabetes and periodontitis, group 5: uncontrolled type 2 diabetes and periodontally healthy individuals, group 6: uncontrolled type 2 diabetes and periodontitis. The study was planned as a randomized, single-blind, parallel design. Periodontal indexes were recorded clinically and the concentrations of visfatin, fetuin-A and sirtuin 1 in gingival crevicular fluid were assessed biochemically. After baseline examinations \[Silness-Löe plaque index (PI), Löe-Silness gingival index (GI), probing pocket depth (PPD), clinical attachment level (CAL), bleeding on probing (BOP)\], initial periodontal treatment was completed using a full-mouth treatment protocol. Data were collected at baseline and at 3 months.
Primary purpose: TREATMENT

Brief summary: The aim of this study is to determine the concentrations of Visfatin, Fetuin-A and Sirtuin 1 in the gingival crevicular fluid and clinical periodontal parameters in diabetic and systemically healthy individuals and to determine whether non-surgical periodontal treatment had any effect on these biomarkers and periodontal clinical parameters at the end of a 3-month follow-up period. The hypothesis of our study is that gingival crevicular fluid Visfatin, Fetuin-A and Sirtuin 1 concentrations will change with non-surgical periodontal treatment in type 2 diabetic and systemically healthy individuals and that this change will be associated with diabetes and clinical parameters.

Detailed description: Sixty-six patients were divided into six equal groups; group 1: systemically and periodontally healthy individuals, group 2: systemically healthy individuals with periodontitis, group 3: controlled type 2 diabetes and periodontally healthy individuals, group 4: controlled type 2 diabetes and periodontitis, group 5: uncontrolled type 2 diabetes and periodontally healthy individuals, group 6: uncontrolled type 2 diabetes and periodontitis. The study was planned as a randomized, single-blind, parallel design. Periodontal clinical parameters (Silness-Löe plaque index, Löe-Silness gingival index, probing pocket depth, clinical attachment level, bleeding on probing) were recorded clinically and concentrations of visfatin, fetuin-A and sirtuin 1 in gingival crevicular fluid were assessed biochemically. After baseline examinations, periodontal treatment was completed using a nonsurgical periodontal treatment protocol completed in 24 hours. Periodontal clinical parameters and gingival crevicular fluid were recorded at baseline and 3 months after periodontal treatment. Biochemical analysis and statistical evaluation were performed.

Eligibility criteria: Inclusion Criteria:

* Volunteering to participate in the study
* To be over 18 years old
* No periodontal treatment in the last 6 months
* Being systemically healthy except for type 2 diabetes
* Not taking medication for any reason except type 2 diabetes
* HbA1c \<7 in controlled Type 2 diabetes group
* HbA1c ≥7 in uncontrolled Type 2 diabetes group
* Not smoking or drinking alcohol

Exclusion Criteria:

* Not volunteering to participate in the study
* Under 18 years of age
* Periodontal treatment in the last 6 months
* Having any systemic disease affecting the periodontal condition
* Having used local or systemic antibiotics in the last 3 months
* Use of anti-inflammatory, steroid drugs in the last 3 months
* Taking vitamin, mineral or antioxidant supplements in the last 3 months
* Being pregnant or lactating
* Regular use of mouthwash
* Smoking or drinking alcohol

Primary outcomes:
measure: Plaque index (PI)
timeFrame: Baseline to 3 months after treatment
measure: Gingival index (GI)
timeFrame: Baseline to 3 months after treatment
measure: Bleeding on probing index (BPI)
timeFrame: Baseline to 3 months after treatment
measure: Probable pocket depth (PPD)
timeFrame: Baseline to 3 months after treatment
measure: Clinical attachment level (CAL)
timeFrame: Baseline to 3 months after treatment
measure: HbA1c level in blood plasma
timeFrame: Baseline to 3 months after treatment
measure: Gingival crevicular fluid (GCF) quantity
timeFrame: Baseline to 3 months after treatment
measure: Visfatin concentration in GCF
timeFrame: Baseline to 3 months after treatment
measure: Fetuin-A concentration in GCF
timeFrame: Baseline to 3 months after treatment
measure: Sirtuin 1 concentration in GCF
timeFrame: Baseline to 3 months after treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Samsun
country: Turkey
facility: Ondokuz Mayıs University, Faculty of Dentistry, Department of Periodontology
Study officials:
affiliation: Ondokuzmayis University, Faculty of Dentistry, Department of Periodontology, Samsun, Turkey.
name: Burcu OZKAN CETINKAYA, Prof.
role: STUDY_DIRECTOR
affiliation: Ondokuzmayis University, Faculty of Dentistry, Department of Periodontology, Samsun, Turkey.
name: Aysun AYDEMIR INAM, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Ondokuzmayis University, Faculty of Medicine Department of Biochemistry, Samsun, Turkey.
name: Bahattin AVCI, Prof.
role: STUDY_CHAIR
References: