Salivary C1P and PGE2 Levels in Periodontitis Patients With T2DM and Effect of Non-Surgical Periodontal Treatment
NCT ID: NCT05454059
Last Updated: 2022-07-12
Study Results
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Basic Information
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COMPLETED
NA
102 participants
INTERVENTIONAL
2020-10-22
2022-06-22
Brief Summary
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A total of 102 subjects were included. Clinical periodontal measurements, saliva samples were collected from each individual at baseline and 3 months after non-surgical periodontal treatmet in periodontitis groups. Salivary C1P and PGE2 levels were determined by enzyme-linked immunosorbent assay (ELISA) method.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Group 1 (HH)
17 systemically healthy + periodontally healthy (normoglycemic)
ELISA Test
C1P and PGE2 levels in saliva samples obtained, and will be examined by ELISA test.
Periodontal Examination
All diagnostic procedures were performed with examination instruments (periodontal probe, dental mirror, x-ray device, etc.). Periodontal clinical index measurements (PI, GI, BOP, PPD, CAL) recorded from all teeth. Routine panoramic radiographs were taken from all patients to determine alveolar bone resorption. Vertical/horizontal bone losses on the radiographs were evaluated and used in the diagnosis of periodontitis.
Saliva Sample Collection
Saliva samples were collected from all subjects in the morning. Unstimulated saliva from each patient was collected by standard defined spitting method without stimulation.
Group 2 (HP)
17 systemic healthy + grade A periodontitis
Non-surgical periodontal treatment
Routine non-surgical periodontal treatment will be applied to patients with periodontitis. The main aim of non-surgical periodontal treatment is to protect, heal and maintain the existing dentition. For this purpose, using manual, sonic or ultrasonic instruments, microbial dental plaque and calculus are removed by tooth surface cleaning and root surface straightening.
ELISA Test
C1P and PGE2 levels in saliva samples obtained, and will be examined by ELISA test.
Periodontal Examination
All diagnostic procedures were performed with examination instruments (periodontal probe, dental mirror, x-ray device, etc.). Periodontal clinical index measurements (PI, GI, BOP, PPD, CAL) recorded from all teeth. Routine panoramic radiographs were taken from all patients to determine alveolar bone resorption. Vertical/horizontal bone losses on the radiographs were evaluated and used in the diagnosis of periodontitis.
Saliva Sample Collection
Saliva samples were collected from all subjects in the morning. Unstimulated saliva from each patient was collected by standard defined spitting method without stimulation.
Group 3 (T2D+H)
17 T2DM (HbA1c\<%7) + periodontally healthy
ELISA Test
C1P and PGE2 levels in saliva samples obtained, and will be examined by ELISA test.
Periodontal Examination
All diagnostic procedures were performed with examination instruments (periodontal probe, dental mirror, x-ray device, etc.). Periodontal clinical index measurements (PI, GI, BOP, PPD, CAL) recorded from all teeth. Routine panoramic radiographs were taken from all patients to determine alveolar bone resorption. Vertical/horizontal bone losses on the radiographs were evaluated and used in the diagnosis of periodontitis.
Saliva Sample Collection
Saliva samples were collected from all subjects in the morning. Unstimulated saliva from each patient was collected by standard defined spitting method without stimulation.
HbA1c Level
Measurement of HbA1c levels from blood tests
Group 4 (T2D+P)
17 T2DM (HbA1c\<%7) + grade B periodontitis
Non-surgical periodontal treatment
Routine non-surgical periodontal treatment will be applied to patients with periodontitis. The main aim of non-surgical periodontal treatment is to protect, heal and maintain the existing dentition. For this purpose, using manual, sonic or ultrasonic instruments, microbial dental plaque and calculus are removed by tooth surface cleaning and root surface straightening.
ELISA Test
C1P and PGE2 levels in saliva samples obtained, and will be examined by ELISA test.
Periodontal Examination
All diagnostic procedures were performed with examination instruments (periodontal probe, dental mirror, x-ray device, etc.). Periodontal clinical index measurements (PI, GI, BOP, PPD, CAL) recorded from all teeth. Routine panoramic radiographs were taken from all patients to determine alveolar bone resorption. Vertical/horizontal bone losses on the radiographs were evaluated and used in the diagnosis of periodontitis.
Saliva Sample Collection
Saliva samples were collected from all subjects in the morning. Unstimulated saliva from each patient was collected by standard defined spitting method without stimulation.
HbA1c Level
Measurement of HbA1c levels from blood tests
Group 5 (T2D-H)
17 T2DM (HbA1c≥%7) + periodontally healthy
ELISA Test
C1P and PGE2 levels in saliva samples obtained, and will be examined by ELISA test.
Periodontal Examination
All diagnostic procedures were performed with examination instruments (periodontal probe, dental mirror, x-ray device, etc.). Periodontal clinical index measurements (PI, GI, BOP, PPD, CAL) recorded from all teeth. Routine panoramic radiographs were taken from all patients to determine alveolar bone resorption. Vertical/horizontal bone losses on the radiographs were evaluated and used in the diagnosis of periodontitis.
Saliva Sample Collection
Saliva samples were collected from all subjects in the morning. Unstimulated saliva from each patient was collected by standard defined spitting method without stimulation.
HbA1c Level
Measurement of HbA1c levels from blood tests
Group 6 (T2D-P)
17 T2DM (HbA1c≥%7) + grade C periodontitis
Non-surgical periodontal treatment
Routine non-surgical periodontal treatment will be applied to patients with periodontitis. The main aim of non-surgical periodontal treatment is to protect, heal and maintain the existing dentition. For this purpose, using manual, sonic or ultrasonic instruments, microbial dental plaque and calculus are removed by tooth surface cleaning and root surface straightening.
ELISA Test
C1P and PGE2 levels in saliva samples obtained, and will be examined by ELISA test.
Periodontal Examination
All diagnostic procedures were performed with examination instruments (periodontal probe, dental mirror, x-ray device, etc.). Periodontal clinical index measurements (PI, GI, BOP, PPD, CAL) recorded from all teeth. Routine panoramic radiographs were taken from all patients to determine alveolar bone resorption. Vertical/horizontal bone losses on the radiographs were evaluated and used in the diagnosis of periodontitis.
Saliva Sample Collection
Saliva samples were collected from all subjects in the morning. Unstimulated saliva from each patient was collected by standard defined spitting method without stimulation.
HbA1c Level
Measurement of HbA1c levels from blood tests
Interventions
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Non-surgical periodontal treatment
Routine non-surgical periodontal treatment will be applied to patients with periodontitis. The main aim of non-surgical periodontal treatment is to protect, heal and maintain the existing dentition. For this purpose, using manual, sonic or ultrasonic instruments, microbial dental plaque and calculus are removed by tooth surface cleaning and root surface straightening.
ELISA Test
C1P and PGE2 levels in saliva samples obtained, and will be examined by ELISA test.
Periodontal Examination
All diagnostic procedures were performed with examination instruments (periodontal probe, dental mirror, x-ray device, etc.). Periodontal clinical index measurements (PI, GI, BOP, PPD, CAL) recorded from all teeth. Routine panoramic radiographs were taken from all patients to determine alveolar bone resorption. Vertical/horizontal bone losses on the radiographs were evaluated and used in the diagnosis of periodontitis.
Saliva Sample Collection
Saliva samples were collected from all subjects in the morning. Unstimulated saliva from each patient was collected by standard defined spitting method without stimulation.
HbA1c Level
Measurement of HbA1c levels from blood tests
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Have not received periodontal treatment in the last 6 months,
* Does not have any systemic disease and does not use drugs,
* Not using local or systemic antibiotics in the last 3 months,
* HbA1c \<%7 for the controlled T2DM group,
* HbA1c ≥7% for the uncontrolled T2DM group,
* For female patients who are not in the pregnancy or lactation period,
* Non-smoker,
* Not regularly using mouthwash/mouthwash.
Exclusion Criteria
* Under 30 years old, over 65 years old
* Having any systemic disease affecting the periodontal condition,
* To use any medication that may affect the inflammatory process in the last 3 months,
* Using local or systemic antibiotics in the last 3 months,
* To have had periodontal treatment in the last 6 months,
* Being in pregnancy or lactation period for female patients,
* Using mouthwash regularly
* Smoking
30 Years
65 Years
ALL
Yes
Sponsors
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Ondokuz Mayıs University
OTHER
Responsible Party
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SELMAN YILMAZ CICEK
Principal Investigator
Locations
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Ondokuz Mayis University
Samsun, , Turkey (Türkiye)
Countries
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Other Identifiers
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2020/598
Identifier Type: -
Identifier Source: org_study_id
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