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

NCT05662475 | Completed

• 1 other identifier: B.30.2.ODM.0.20.08/462
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Periodontal Diseases; Type 2 Diabetes; Periodontitis

Keywords

visfatin; fetuin-A; sirtuin 1; periodontitis; type 2 diabetes; non-surgical periodontal treatment; gingival crevicular fluid

Outcome Measures

Primary Outcomes (10)

• 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

• 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

• 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

• 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

• 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

• HbA1c level in blood plasma

  NSPT reduced HbA1c levels of patients with type 2 diabetes.

  Baseline to 3 months after treatment

• 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

• 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

• 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

• 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

Study Arms (6)

group 1: Systemically Healthy, Periodontally Healthy (n:11)

EXPERIMENTAL

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.

Diagnostic Test: GCF (gingival crevicular fluid) collection

group 2: Systemically Healthy, Periodontitis (n:11)

EXPERIMENTAL

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.

Diagnostic Test: GCF (gingival crevicular fluid) collection; Procedure: Non-surgical periodontal treatment completed in 24 hours

grup 3: Controlled Type 2 Diabetes, Periodontally Healthy (n:11)

EXPERIMENTAL

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.

Diagnostic Test: GCF (gingival crevicular fluid) collection; Diagnostic Test: HbA1c level determination in blood serum

group 4: Controlled Type 2 Diabetes, Periodontitis (n:11)

EXPERIMENTAL

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.

Diagnostic Test: GCF (gingival crevicular fluid) collection; Procedure: Non-surgical periodontal treatment completed in 24 hours; Diagnostic Test: HbA1c level determination in blood serum

grup 5: Uncontrolled Type 2 Diabetes, Periodontally Healthy (n:11)

EXPERIMENTAL

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.

Diagnostic Test: GCF (gingival crevicular fluid) collection; Diagnostic Test: HbA1c level determination in blood serum

group 6: Uncontrolled Type 2 Diabetes, Periodontitis (n:11)

EXPERIMENTAL

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.

Diagnostic Test: GCF (gingival crevicular fluid) collection; Procedure: Non-surgical periodontal treatment completed in 24 hours; Diagnostic Test: HbA1c level determination in blood serum

Interventions

GCF (gingival crevicular fluid) collection DIAGNOSTIC_TEST

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.

group 1: Systemically Healthy, Periodontally Healthy (n:11); group 2: Systemically Healthy, Periodontitis (n:11); group 4: Controlled Type 2 Diabetes, Periodontitis (n:11); group 6: Uncontrolled Type 2 Diabetes, Periodontitis (n:11); grup 3: Controlled Type 2 Diabetes, Periodontally Healthy (n:11); grup 5: Uncontrolled Type 2 Diabetes, Periodontally Healthy (n:11)

Non-surgical periodontal treatment completed in 24 hours PROCEDURE

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.

group 2: Systemically Healthy, Periodontitis (n:11); group 4: Controlled Type 2 Diabetes, Periodontitis (n:11); group 6: Uncontrolled Type 2 Diabetes, Periodontitis (n:11)

HbA1c level determination in blood serum DIAGNOSTIC_TEST

Blood samples were taken from the patients and HbA1c concentration was measured in serum.

group 4: Controlled Type 2 Diabetes, Periodontitis (n:11); group 6: Uncontrolled Type 2 Diabetes, Periodontitis (n:11); grup 3: Controlled Type 2 Diabetes, Periodontally Healthy (n:11); grup 5: Uncontrolled Type 2 Diabetes, Periodontally Healthy (n:11)

Eligibility Criteria

• Age: 31 Years - 81 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ondokuz Mayıs University: lead

Study Sites (1)

Ondokuz Mayıs University, Faculty of Dentistry, Department of Periodontology

Samsun, 55270, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Periodontal Diseases; Diabetes Mellitus, Type 2; Periodontitis

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Burcu OZKAN CETINKAYA, Prof.

  Ondokuzmayis University, Faculty of Dentistry, Department of Periodontology, Samsun, Turkey.

  STUDY DIRECTOR

• Aysun AYDEMIR INAM, Dr.

  Ondokuzmayis University, Faculty of Dentistry, Department of Periodontology, Samsun, Turkey.

  PRINCIPAL INVESTIGATOR

• Bahattin AVCI, Prof.

  Ondokuzmayis University, Faculty of Medicine Department of Biochemistry, Samsun, Turkey.

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor in Periodontology

Model Details: 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.

Study Record Dates

• First Submitted: December 6, 2022
• First Posted: December 22, 2022
• Study Start: November 15, 2021
• Primary Completion: March 14, 2022
• Study Completion: July 15, 2022
• Last Updated: December 22, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)