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

O

Ondokuz Mayıs University

Status

Completed

Conditions

Periodontitis
Periodontal Diseases
Type 2 Diabetes

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT05662475
B.30.2.ODM.0.20.08/462

Details and patient eligibility

About

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.

Full 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.

Enrollment

66 patients

Sex

All

Ages

31 to 81 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

66 participants in 6 patient groups

group 1: Systemically Healthy, Periodontally Healthy (n:11)
Experimental group
Description:
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.
Treatment:
Diagnostic Test: GCF (gingival crevicular fluid) collection
group 2: Systemically Healthy, Periodontitis (n:11)
Experimental group
Description:
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.
Treatment:
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 group
Description:
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.
Treatment:
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 group
Description:
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.
Treatment:
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 group
Description:
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.
Treatment:
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 group
Description:
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.
Treatment:
Diagnostic Test: GCF (gingival crevicular fluid) collection
Procedure: Non-surgical periodontal treatment completed in 24 hours
Diagnostic Test: HbA1c level determination in blood serum

Trial contacts and locations

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Data sourced from clinicaltrials.gov

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