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

Not Applicable

Completed

• Conditions: Periodontitis; Type 2 Diabetes; Periodontal Diseases
• Interventions: Diagnostic Test: GCF (gingival crevicular fluid) collection; Diagnostic Test: HbA1c level determination in blood serum; Procedure: Non-surgical periodontal treatment completed in 24 hours

• Registration Number: NCT05662475
• Lead Sponsor: Ondokuz Mayıs University

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.

Study Timeline

• Study Start: 2021-11-15
• Primary Completion: 2022-03-14
• Study Completion: 2022-07-15
• Status Verified: 2022-12
• Study First Submitted: 2022-12-06
• Study First Submitted QC: 2022-12-14
• Last Update Submitted: 2022-12-14
• Study First Posted: 2022-12-22
• Last Update Posted: 2022-12-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
grup 3: Controlled Type 2 Diabetes, Periodontally Healthy (n:11)	HbA1c level determination in blood serum	Plaque index, gingival index, bleeding on probing index, probing pocket depth and clinical attachment level were measured at 6 sites (buccomesial, midbuccal, buccodistal, lingual/palatal mesial, midlingual/palatal, lingual/palatal distal) of each tooth to evaluate the periodontal status of the patients. On the day of examination, panoramic radiographs were taken from all patients to determine alveolar bone loss. HbA1c values were measured. Gingival crevicular fluid is collected from the patients. Gingival crevicular fluid samples were collected from 5 randomly selected teeth with GI=0, PI=0 and PPD ≤3. Then, each paper strip from each tooth was individually placed in sterile 0.5 ml eppendorf tubes. Eppendorf tubes were stored at -80°C. Oral hygiene education was given to each patient. Modified Bass technique was explained as a brushing technique. Interdental cleaning was explained.
group 4: Controlled Type 2 Diabetes, Periodontitis (n:11)	GCF (gingival crevicular fluid) collection	Plaque index, gingival index, bleeding on probing index, probing pocket depth and clinical attachment levels were measured from 6 sites of each tooth to evaluate the periodontal status of the patients. Panoramic radiographs were taken from all patients. Vertical/horizontal bone loss on the radiographs was evaluated to determine the stage and grade of periodontitis. HbA1c levels are determined. Gingival crevicular fluid samples were collected from the 5 periodontal pockets with the deepest PPD before and 3 months after treatment. Samples were stored at -80°C. Non-surgical periodontal treatments were started under local anesthesia. Oral hygiene education was given after treatment. Modified Bass technique was explained as a brushing technique. Interdental cleaning was explained. The patient was told not to use any chemical agent for plaque removal. 3 months after the treatment gingival crevicular fluid samples are collected and clinical examination parameters were measured again.
group 4: Controlled Type 2 Diabetes, Periodontitis (n:11)	Non-surgical periodontal treatment completed in 24 hours	Plaque index, gingival index, bleeding on probing index, probing pocket depth and clinical attachment levels were measured from 6 sites of each tooth to evaluate the periodontal status of the patients. Panoramic radiographs were taken from all patients. Vertical/horizontal bone loss on the radiographs was evaluated to determine the stage and grade of periodontitis. HbA1c levels are determined. Gingival crevicular fluid samples were collected from the 5 periodontal pockets with the deepest PPD before and 3 months after treatment. Samples were stored at -80°C. Non-surgical periodontal treatments were started under local anesthesia. Oral hygiene education was given after treatment. Modified Bass technique was explained as a brushing technique. Interdental cleaning was explained. The patient was told not to use any chemical agent for plaque removal. 3 months after the treatment gingival crevicular fluid samples are collected and clinical examination parameters were measured again.
group 1: Systemically Healthy, Periodontally Healthy (n:11)	GCF (gingival crevicular fluid) collection	Plaque index, gingival index, bleeding on probing index, probing pocket depth and clinical attachment level were measured at 6 sites (buccomesial, midbuccal, buccodistal, lingual/palatal mesial, midlingual/palatal, lingual/palatal distal) of each tooth to evaluate the periodontal status of the patients. On the day of examination, panoramic radiographs were taken from all patients to determine alveolar bone loss. Gingival crevicular fluid is collected from the patients. Gingival crevicular fluid samples were collected from 5 randomly selected teeth with GI=0, PI=0 and PPD ≤3. Then, each paper strip from each tooth was individually placed in sterile 0.5 ml eppendorf tubes. Eppendorf tubes were stored at -80°C. Oral hygiene education was given to each patient. Modified Bass technique was explained as a brushing technique. Interdental brush or dental floss was recommended for interdental cleaning according to the condition of the patient's interdental areas and its use was demonstrated.
grup 3: Controlled Type 2 Diabetes, Periodontally Healthy (n:11)	GCF (gingival crevicular fluid) collection	Plaque index, gingival index, bleeding on probing index, probing pocket depth and clinical attachment level were measured at 6 sites (buccomesial, midbuccal, buccodistal, lingual/palatal mesial, midlingual/palatal, lingual/palatal distal) of each tooth to evaluate the periodontal status of the patients. On the day of examination, panoramic radiographs were taken from all patients to determine alveolar bone loss. HbA1c values were measured. Gingival crevicular fluid is collected from the patients. Gingival crevicular fluid samples were collected from 5 randomly selected teeth with GI=0, PI=0 and PPD ≤3. Then, each paper strip from each tooth was individually placed in sterile 0.5 ml eppendorf tubes. Eppendorf tubes were stored at -80°C. Oral hygiene education was given to each patient. Modified Bass technique was explained as a brushing technique. Interdental cleaning was explained.
grup 5: Uncontrolled Type 2 Diabetes, Periodontally Healthy (n:11)	HbA1c level determination in blood serum	Plaque index, gingival index, bleeding on probing index, probing pocket depth and clinical attachment level were measured at 6 sites (buccomesial, midbuccal, buccodistal, lingual/palatal mesial, midlingual/palatal, lingual/palatal distal) of each tooth to evaluate the periodontal status of the patients. On the day of examination, panoramic radiographs were taken from all patients to determine alveolar bone loss. HbA1c values were measured. Gingival crevicular fluid is collected from the patients. Gingival crevicular fluid samples were collected from 5 randomly selected teeth with GI=0, PI=0 and PPD ≤3. Then, each paper strip from each tooth was individually placed in sterile 0.5 ml eppendorf tubes. Eppendorf tubes were stored at -80°C. Oral hygiene education was given to each patient. Modified Bass technique was explained as a brushing technique. Interdental cleaning was explained.
group 2: Systemically Healthy, Periodontitis (n:11)	GCF (gingival crevicular fluid) collection	Plaque index, gingival index, bleeding on probing index, probing pocket depth and clinical attachment levels were measured from 6 sites of each tooth to evaluate the periodontal status of the patients. Panoramic radiographs were taken from all patients. Vertical/horizontal bone loss on the radiographs was evaluated to determine the stage and grade of periodontitis. Gingival crevicular fluid samples were collected from the 5 periodontal pockets with the deepest PPD before and 3 months after treatment. Eppendorf tubes were stored at -80°C. Non-surgical periodontal treatments were started under local anesthesia. Oral hygiene education was given to each patient after treatment. Modified Bass technique was explained as a brushing technique. Interdental cleaning was explained. The patient was told not to use any chemical agent for plaque removal. 3 months after the treatment gingival crevicular fluid samples are collected and clinical examination parameters were measured again.
group 2: Systemically Healthy, Periodontitis (n:11)	Non-surgical periodontal treatment completed in 24 hours	Plaque index, gingival index, bleeding on probing index, probing pocket depth and clinical attachment levels were measured from 6 sites of each tooth to evaluate the periodontal status of the patients. Panoramic radiographs were taken from all patients. Vertical/horizontal bone loss on the radiographs was evaluated to determine the stage and grade of periodontitis. Gingival crevicular fluid samples were collected from the 5 periodontal pockets with the deepest PPD before and 3 months after treatment. Eppendorf tubes were stored at -80°C. Non-surgical periodontal treatments were started under local anesthesia. Oral hygiene education was given to each patient after treatment. Modified Bass technique was explained as a brushing technique. Interdental cleaning was explained. The patient was told not to use any chemical agent for plaque removal. 3 months after the treatment gingival crevicular fluid samples are collected and clinical examination parameters were measured again.
group 4: Controlled Type 2 Diabetes, Periodontitis (n:11)	HbA1c level determination in blood serum	Plaque index, gingival index, bleeding on probing index, probing pocket depth and clinical attachment levels were measured from 6 sites of each tooth to evaluate the periodontal status of the patients. Panoramic radiographs were taken from all patients. Vertical/horizontal bone loss on the radiographs was evaluated to determine the stage and grade of periodontitis. HbA1c levels are determined. Gingival crevicular fluid samples were collected from the 5 periodontal pockets with the deepest PPD before and 3 months after treatment. Samples were stored at -80°C. Non-surgical periodontal treatments were started under local anesthesia. Oral hygiene education was given after treatment. Modified Bass technique was explained as a brushing technique. Interdental cleaning was explained. The patient was told not to use any chemical agent for plaque removal. 3 months after the treatment gingival crevicular fluid samples are collected and clinical examination parameters were measured again.
group 6: Uncontrolled Type 2 Diabetes, Periodontitis (n:11)	Non-surgical periodontal treatment completed in 24 hours	Plaque index, gingival index, bleeding on probing index, probing pocket depth and clinical attachment levels were measured from 6 sites of each tooth to evaluate the periodontal status of the patients. Panoramic radiographs were taken from all patients. Vertical/horizontal bone loss on the radiographs was evaluated to determine the stage and grade of periodontitis. HbA1c levels are determined. Gingival crevicular fluid samples were collected from the 5 periodontal pockets with the deepest PPD before and 3 months after treatment. Samples were stored at -80°C. Non-surgical periodontal treatments were started under local anesthesia. Oral hygiene education was given after treatment. Modified Bass technique was explained as a brushing technique. Interdental cleaning was explained. The patient was told not to use any chemical agent for plaque removal. 3 months after the treatment gingival crevicular fluid samples are collected and clinical examination parameters were measured again.
group 6: Uncontrolled Type 2 Diabetes, Periodontitis (n:11)	HbA1c level determination in blood serum	Plaque index, gingival index, bleeding on probing index, probing pocket depth and clinical attachment levels were measured from 6 sites of each tooth to evaluate the periodontal status of the patients. Panoramic radiographs were taken from all patients. Vertical/horizontal bone loss on the radiographs was evaluated to determine the stage and grade of periodontitis. HbA1c levels are determined. Gingival crevicular fluid samples were collected from the 5 periodontal pockets with the deepest PPD before and 3 months after treatment. Samples were stored at -80°C. Non-surgical periodontal treatments were started under local anesthesia. Oral hygiene education was given after treatment. Modified Bass technique was explained as a brushing technique. Interdental cleaning was explained. The patient was told not to use any chemical agent for plaque removal. 3 months after the treatment gingival crevicular fluid samples are collected and clinical examination parameters were measured again.
grup 5: Uncontrolled Type 2 Diabetes, Periodontally Healthy (n:11)	GCF (gingival crevicular fluid) collection	Plaque index, gingival index, bleeding on probing index, probing pocket depth and clinical attachment level were measured at 6 sites (buccomesial, midbuccal, buccodistal, lingual/palatal mesial, midlingual/palatal, lingual/palatal distal) of each tooth to evaluate the periodontal status of the patients. On the day of examination, panoramic radiographs were taken from all patients to determine alveolar bone loss. HbA1c values were measured. Gingival crevicular fluid is collected from the patients. Gingival crevicular fluid samples were collected from 5 randomly selected teeth with GI=0, PI=0 and PPD ≤3. Then, each paper strip from each tooth was individually placed in sterile 0.5 ml eppendorf tubes. Eppendorf tubes were stored at -80°C. Oral hygiene education was given to each patient. Modified Bass technique was explained as a brushing technique. Interdental cleaning was explained.
group 6: Uncontrolled Type 2 Diabetes, Periodontitis (n:11)	GCF (gingival crevicular fluid) collection	Plaque index, gingival index, bleeding on probing index, probing pocket depth and clinical attachment levels were measured from 6 sites of each tooth to evaluate the periodontal status of the patients. Panoramic radiographs were taken from all patients. Vertical/horizontal bone loss on the radiographs was evaluated to determine the stage and grade of periodontitis. HbA1c levels are determined. Gingival crevicular fluid samples were collected from the 5 periodontal pockets with the deepest PPD before and 3 months after treatment. Samples were stored at -80°C. Non-surgical periodontal treatments were started under local anesthesia. Oral hygiene education was given after treatment. Modified Bass technique was explained as a brushing technique. Interdental cleaning was explained. The patient was told not to use any chemical agent for plaque removal. 3 months after the treatment gingival crevicular fluid samples are collected and clinical examination parameters were measured again.

Primary Outcome Measures

Name	Time	Method
Bleeding on probing index (BPI)	Baseline to 3 months after treatment	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.
Visfatin concentration in GCF	Baseline to 3 months after treatment	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.
Gingival crevicular fluid (GCF) quantity	Baseline to 3 months after treatment	The amount of gingival crevicular fluid was not affected by periodontal status in patients with Type 2 diabetes.
Clinical attachment level (CAL)	Baseline to 3 months after treatment	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.
Plaque index (PI)	Baseline to 3 months after treatment	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).
Gingival index (GI)	Baseline to 3 months after treatment	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.
HbA1c level in blood plasma	Baseline to 3 months after treatment	NSPT reduced HbA1c levels of patients with type 2 diabetes.
Sirtuin 1 concentration in GCF	Baseline to 3 months after treatment	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.
Probable pocket depth (PPD)	Baseline to 3 months after treatment	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.
Fetuin-A concentration in GCF	Baseline to 3 months after treatment	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.

Trial Locations

Locations (1)

Ondokuz Mayıs University, Faculty of Dentistry, Department of Periodontology; 🇹🇷 Samsun, Turkey