Periodontal DiseasesNCT05662475
Effect of Periodontal Treatment on Visfatin, fetuin-a and Sirtuin 1 of Patients With Periodontitis and Type 2 Diabetes
A study testing GCF (gingival crevicular fluid) collection, Non-surgical periodontal treatment completed in 24 hours and HbA1c level determination in blood serum in people with Periodontal Diseases and Type 2 Diabetes, run by Ondokuz Mayıs University at 1 site in Turkey (Türkiye).
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… Read more about this study
- Who is it for?
- Ages 31 to 81 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontal Diseases, Type 2 Diabetes, Periodontitis
- What is being tested?
- GCF (gingival crevicular fluid) collection, Non-surgical periodontal treatment completed in 24 hours and HbA1c level determination in blood serum
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Nov 2021to 15 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 31 to 81 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- Taking vitamin, mineral or antioxidant supplements in the last 3 months
- Being pregnant or lactating
- Regular use of mouthwash
- Smoking or drinking alcohol
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ondokuz Mayıs University, Faculty of Dentistry, Department of Periodontology
Samsun, 55270
About this study
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
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.
Read the 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.
- Conditions
- Periodontal Diseases, Type 2 Diabetes, Periodontitis
- Being tested
- GCF (gingival crevicular fluid) collection, Non-surgical periodontal treatment completed in 24 hours, HbA1c level determination in blood serum
- Keywords
- visfatin, fetuin-A, sirtuin 1, periodontitis, type 2 diabetes, non-surgical periodontal treatment, gingival crevicular fluid
- Medical subject headings
- Periodontal Diseases, Diabetes Mellitus, Type 2, Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GCF (gingival crevicular fluid) collectionDiagnostic 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.
Non-surgical periodontal treatment completed in 24 hoursProcedure or surgery
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.
HbA1c level determination in blood serumDiagnostic test
Blood samples were taken from the patients and HbA1c concentration was measured in serum.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: Diagnostic Test: GCF (gingival crevicular fluid) collection; Procedure: Non-surgical periodontal treatment completed in 24 hours; Diagnostic Test: HbA1c level determination in blood serum |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline to 3 months after treatment
HbA1c level in blood plasma
NSPT reduced HbA1c levels of patients with type 2 diabetes.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline to 3 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2022
- Study start15 Nov 2021
- Primary completion14 Mar 2022
- Study completion15 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontal DiseasesStudies of the same condition, open and under way.
- More trials run by Ondokuz Mayıs UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ondokuz Mayıs University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Burcu Ozkan Cetinkaya, Ondokuz Mayıs University
- Investigators
- Burcu OZKAN CETINKAYA, Prof., Study director, Ondokuzmayis University, Faculty of Dentistry, Department of Periodontology, Samsun, Turkey.Aysun AYDEMIR INAM, Dr., Principal investigator, Ondokuzmayis University, Faculty of Dentistry, Department of Periodontology, Samsun, Turkey.Bahattin AVCI, Prof., Study chair, Ondokuzmayis University, Faculty of Medicine Department of Biochemistry, Samsun, Turkey.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05662475
- Sponsor's protocol ID
- B.30.2.ODM.0.20.08/462
- Status last verified
- Dec 2022
- First submitted
- 6 Dec 2022
- Last updated
- 22 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05662475
- Acronym / sponsor ID
- B.30.2.ODM.0.20.08/462
- Conditions
- Periodontal Diseases, Type 2 Diabetes, Periodontitis
- Keywords
- visfatin, fetuin-A, sirtuin 1, periodontitis, type 2 diabetes, non-surgical periodontal treatment, gingival crevicular fluid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Ondokuz Mayıs UniversityUniversity, hospital or other
- Study start
- 15 Nov 2021 (actual)
- Primary completion
- 14 Mar 2022 (actual)
- Study completion
- 15 Jul 2022 (actual)
- First posted
- 22 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 6
- 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.
| Arm | Type | Receives |
|---|---|---|
| group 1: Systemically Healthy, Periodontally Healthy (n:11) | Experimental | Diagnostic Test: GCF (gingival crevicular fluid) collectionPlaque 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. |
| group 2: Systemically Healthy, Periodontitis (n:11) | Experimental | Diagnostic Test: GCF (gingival crevicular fluid) collection, Procedure: Non-surgical periodontal treatment completed in 24 hoursPlaque 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. |
| grup 3: Controlled Type 2 Diabetes, Periodontally Healthy (n:11) | Experimental | Diagnostic Test: GCF (gingival crevicular fluid) collection, Diagnostic Test: HbA1c level determination in blood serumPlaque 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) | Experimental | Diagnostic Test: GCF (gingival crevicular fluid) collection, Procedure: Non-surgical periodontal treatment completed in 24 hours, Diagnostic Test: HbA1c level determination in blood serumPlaque 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) | Experimental | Diagnostic Test: GCF (gingival crevicular fluid) collection, Diagnostic Test: HbA1c level determination in blood serumPlaque 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) | Experimental | Diagnostic Test: GCF (gingival crevicular fluid) collection, Procedure: Non-surgical periodontal treatment completed in 24 hours, Diagnostic Test: HbA1c level determination in blood serumPlaque 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. |
Who may qualify
- Ages
- 31 to 81 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GCF (gingival crevicular fluid) collectionPrior 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. | Diagnostic test | 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 hoursAfter 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. | Procedure or surgery | 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 serumBlood samples were taken from the patients and HbA1c concentration was measured in serum. | Diagnostic test | 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) |
Primary outcome
Plaque index (PI)
Time frame: 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)
Time frame: 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.
Bleeding on probing index (BPI)
Time frame: 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.
Probable pocket depth (PPD)
Time frame: 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.
Clinical attachment level (CAL)
Time frame: 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.
HbA1c level in blood plasma
Time frame: Baseline to 3 months after treatment
NSPT reduced HbA1c levels of patients with type 2 diabetes.
Gingival crevicular fluid (GCF) quantity
Time frame: Baseline to 3 months after treatment
The amount of gingival crevicular fluid was not affected by periodontal status in patients with Type 2 diabetes.
Visfatin concentration in GCF
Time frame: 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.
Fetuin-A concentration in GCF
Time frame: 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.
Sirtuin 1 concentration in GCF
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Burcu OZKAN CETINKAYA, Prof. study director
Ondokuzmayis University, Faculty of Dentistry, Department of Periodontology, Samsun, Turkey.
Aysun AYDEMIR INAM, Dr. principal investigator
Ondokuzmayis University, Faculty of Dentistry, Department of Periodontology, Samsun, Turkey.
Bahattin AVCI, Prof. study chair
Ondokuzmayis University, Faculty of Medicine Department of Biochemistry, Samsun, Turkey.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GCF (gingival crevicular fluid) collection, Non-surgical periodontal treatment completed in 24 hours and HbA1c level determination in blood serum in people with Periodontal Diseases and Type 2 Diabetes, run by Ondokuz Mayıs University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plaque index (PI) (time frame: Baseline to 3 months after treatment). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2022.