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

Primary Purpose

Periodontal Diseases, Type 2 Diabetes, Periodontitis

Status

Completed

Phase

Not Applicable

Locations

Turkey

Study Type

Interventional

Intervention

GCF (gingival crevicular fluid) collection

Non-surgical periodontal treatment completed in 24 hours

HbA1c level determination in blood serum

About this trial

This is an interventional treatment trial for Periodontal Diseases focused on measuring visfatin, fetuin-A, sirtuin 1, periodontitis, type 2 diabetes, non-surgical periodontal treatment, gingival crevicular fluid

Eligibility Criteria

31 Years - 81 Years (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

Ondokuz Mayıs University, Faculty of Dentistry, Department of Periodontology

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Arm Label

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

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

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

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

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

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

Arm 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.

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.

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

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).

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.

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.

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.

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.

HbA1c level in blood plasma

NSPT reduced HbA1c levels of patients with type 2 diabetes.

Gingival crevicular fluid (GCF) quantity

The amount of gingival crevicular fluid was not affected by periodontal status in patients with Type 2 diabetes.

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.

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.

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT05662475

First Posted

December 6, 2022

Last Updated

December 14, 2022

Sponsor

Ondokuz Mayıs University

1. Study Identification

Unique Protocol Identification Number

NCT05662475

Brief Title

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

2. Study Status

Record Verification Date

December 2022

Overall Recruitment Status

Completed

Study Start Date

November 15, 2021 (Actual)

Primary Completion Date

March 14, 2022 (Actual)

Study Completion Date

July 15, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Ondokuz Mayıs University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Periodontal Diseases, Type 2 Diabetes, Periodontitis

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

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.

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

66 (Actual)

8. Arms, Groups, and Interventions

Arm Title

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

Arm Type

Experimental

Arm Description

Arm Title

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

Arm Type

Experimental

Arm Description

Arm Title

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

Arm Type

Experimental

Arm 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.

Arm Title

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

Arm Type

Experimental

Arm 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.

Arm Title

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

Arm Type

Experimental

Arm 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.

Arm Title

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

Arm Type

Experimental

Arm 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.

Intervention Type

Diagnostic Test

Intervention Name(s)

GCF (gingival crevicular fluid) collection

Intervention Description

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.

Intervention Type

Procedure

Intervention Name(s)

Non-surgical periodontal treatment completed in 24 hours

Intervention Description

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.

Intervention Type

Diagnostic Test

Intervention Name(s)

HbA1c level determination in blood serum

Intervention Description

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

Primary Outcome Measure Information:

Title

Plaque index (PI)

Description

Time Frame