Effect of Periodontal Treatment on Visfatin, fetuin-a and Sirtuin 1 of Patients With Periodontitis and Type 2 Diabetes
NCT ID: NCT05662475
Last Updated: 2022-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
66 participants
INTERVENTIONAL
2021-11-15
2022-07-15
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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group 1: Systemically Healthy, Periodontally Healthy (n:11)
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.
GCF (gingival crevicular fluid) collection
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 2: Systemically Healthy, Periodontitis (n:11)
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.
GCF (gingival crevicular fluid) collection
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 hours
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.
grup 3: Controlled Type 2 Diabetes, Periodontally Healthy (n:11)
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.
GCF (gingival crevicular fluid) collection
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.
HbA1c level determination in blood serum
Blood samples were taken from the patients and HbA1c concentration was measured in serum.
group 4: Controlled Type 2 Diabetes, Periodontitis (n:11)
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.
GCF (gingival crevicular fluid) collection
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 hours
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 serum
Blood samples were taken from the patients and HbA1c concentration was measured in serum.
grup 5: Uncontrolled Type 2 Diabetes, Periodontally Healthy (n:11)
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.
GCF (gingival crevicular fluid) collection
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.
HbA1c level determination in blood serum
Blood samples were taken from the patients and HbA1c concentration was measured in serum.
group 6: Uncontrolled Type 2 Diabetes, Periodontitis (n:11)
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.
GCF (gingival crevicular fluid) collection
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 hours
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 serum
Blood samples were taken from the patients and HbA1c concentration was measured in serum.
Interventions
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GCF (gingival crevicular fluid) collection
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 hours
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 serum
Blood samples were taken from the patients and HbA1c concentration was measured in serum.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
31 Years
81 Years
ALL
Yes
Sponsors
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Ondokuz Mayıs University
OTHER
Responsible Party
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Burcu Ozkan Cetinkaya
Professor in Periodontology
Principal Investigators
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Burcu OZKAN CETINKAYA, Prof.
Role: STUDY_DIRECTOR
Ondokuzmayis University, Faculty of Dentistry, Department of Periodontology, Samsun, Turkey.
Aysun AYDEMIR INAM, Dr.
Role: PRINCIPAL_INVESTIGATOR
Ondokuzmayis University, Faculty of Dentistry, Department of Periodontology, Samsun, Turkey.
Bahattin AVCI, Prof.
Role: STUDY_CHAIR
Ondokuzmayis University, Faculty of Medicine Department of Biochemistry, Samsun, Turkey.
Locations
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Ondokuz Mayıs University, Faculty of Dentistry, Department of Periodontology
Samsun, , Turkey (Türkiye)
Countries
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Other Identifiers
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B.30.2.ODM.0.20.08/462
Identifier Type: -
Identifier Source: org_study_id