Effect of Periodontal Treatment on Visfatin, fetuin-a and Sirtuin 1 of Patients With Periodontitis and Type 2 Diabetes

Type 2 Diabetes Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05662475
• Other study ID #: B.30.2.ODM.0.20.08/462
• Status: Completed
• Phase: N/A
• Start date: November 15, 2021
• Est. completion date: July 15, 2022

Study information

• Verified date: December 2022
• Source: Ondokuz Mayis University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: July 15, 2022
• Est. primary completion date: March 14, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 31 Years to 81 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Periodontal Diseases
• Periodontitis
• Type 2 Diabetes

Intervention

Diagnostic Test:
• GCF (gingival crevicular fluid) collection
Prior to GCF (gingival crevicular fluid) sampling, supragingival plaque was removed by sterile curets and, after air drying, the surfaces were isolated by cotton rolls. Gingival fluid collection strips were placed in sulcus for 30s. Care was taken not to avoid mechanical trauma and strips contaminated with blood or saliva were discarded. The absorbed GCF volume was estimated by a calibrated instrument. Then, the strips were sealed into sterile tubes before freezing at -80 °C. The readings were converted to an actual volume (µl) by reference to the standard curve.

Procedure:
• Non-surgical periodontal treatment completed in 24 hours
After clinical periodontal parameters were recorded and GCF samples were obtained, non-surgical periodontal treatment was started under local anesthesia. All periodontal treatments were performed by a single investigator. Local infiltrative anesthesia was applied to the buccal and palatal/lingual areas of the maxilla and mandible of the patients. After anesthesia was achieved, scaler and ultrasonic tips of various thicknesses were used together to remove supragingival and subgingival hard attachments. Root surface smoothing was performed with region-specific periodontal curettes. The roughness of the surfaces was controlled using a periodontal probe. Polishing was performed. Oral hygiene education was given to each patient after treatment. Modified Bass technique was explained as a brushing technique. Interdental cleaning is explained. The patient was told not to use any chemical agent for plaque removal.

Diagnostic Test:
• HbA1c level determination in blood serum
Blood samples were taken from the patients and HbA1c concentration was measured in serum.

Locations

Country	Name	City	State
Turkey	Ondokuz Mayis University, Faculty of Dentistry, Department of Periodontology	Samsun

Sponsors (1)

Lead Sponsor	Collaborator
Ondokuz Mayis University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plaque index (PI)	PI was increased in all periodontitis patients with or without type 2 diabetes. Type 2 diabetes has no effect on PI in periodontitis patients. PI was reduced after non-surgical periodontal treatment (NSPT).	Baseline to 3 months after treatment
Primary	Gingival index (GI)	GI was increased in all periodontitis patients with or without type 2 diabetes. Type 2 diabetes has no effect on GI in periodontitis patients. GI was reduced after NSPT.	Baseline to 3 months after treatment
Primary	Bleeding on probing index (BPI)	BPI was increased in all periodontitis patients with or without type 2 diabetes. Type 2 diabetes has no effect on BPI in periodontitis patients. BPI was reduced after NSPT.	Baseline to 3 months after treatment
Primary	Probable pocket depth (PPD)	PPD was increased in all periodontitis patients with or without type 2 diabetes. Type 2 diabetes has no effect on PPD in periodontitis patients. PPD was reduced after NSPT.	Baseline to 3 months after treatment
Primary	Clinical attachment level (CAL)	CAL was increased in all periodontitis patients with or without type 2 diabetes. Type 2 diabetes has no effect on CAL in periodontitis patients. CAL was reduced after NSPT.	Baseline to 3 months after treatment
Primary	HbA1c level in blood plasma	NSPT reduced HbA1c levels of patients with type 2 diabetes.	Baseline to 3 months after treatment
Primary	Gingival crevicular fluid (GCF) quantity	The amount of gingival crevicular fluid was not affected by periodontal status in patients with Type 2 diabetes.	Baseline to 3 months after treatment
Primary	Visfatin concentration in GCF	Visfatin concentrations in GCF were increased in all periodontitis patients. In periodontal healthy patients with Type 2 diabetes visfatin concentrations in GCF were increased. Non-surgical periodontal treatment decreased the concentration of visfatin in GCF.	Baseline to 3 months after treatment
Primary	Fetuin-A concentration in GCF	Fetuin-A concentrations in GCF were decreased in all periodontitis patients. In periodontal healthy patients with Type 2 diabetes fetuin-A concentrations in GCF were increased. Non-surgical periodontal treatment increased the concentration of fetuin-A in GCF.	Baseline to 3 months after treatment
Primary	Sirtuin 1 concentration in GCF	In systemic healthy individuals, periodontitis decreased the concentration of sirtuin 1 in GCF. Type 2 diabetes increased sirtuin 1 concentration in GCF. In controlled type 2 diabetes patients with periodontitis sirtuin 1 concentrations in GCF were increased. In uncontrolled type 2 diabetes patients with periodontitis sirtuin 1 concentrations in GCF were decreased. Non-surgical periodontal treatment increased the concentration of sirtuin 1 in GCF.	Baseline to 3 months after treatment