Salivary C1P and PGE2 Levels in Periodontitis Patients With T2DM and Effect of Non-Surgical Periodontal Treatment

Type 2 Diabetes Clinical Trial

Official title:

Investigation of Salivary Ceramide-1-Phosphate and Prostaglandin E2 Levels in Periodontitis Patients With Poorly and Well-Controlled Type 2 Diabetes and Effect of Non-Surgical Periodontal Treatment: A Randomized Controlled Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05454059
• Other study ID #: 2020/598
• Status: Completed
• Phase: N/A
• Start date: October 22, 2020
• Est. completion date: June 22, 2022

Study information

• Verified date: July 2022
• Source: Ondokuz Mayis University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Diabetes and periodontal disease are the most common chronic multifactorial and inflammatory diseases in humans, and there is a bidirectional relationship between type 2 diabetes and periodontitis. With the negative effects of the control of these two diseases, it results in an increase in the severity of diabetes and periodontitis, and they affect many systems together. To elucidate the role of ceramide, which is one of the possible biochemical mechanisms between diabetes and the degree of glycemic control and periodontitis, in inflammation. Aim of this study is the measurement of C1P and PGE2 in saliva and the effect of non-surgical periodontal treatment, which includes the degree of control of diabetes, oral hygiene education, tooth surface cleaning and root surface arrangement, on 3 months. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: June 22, 2022
• Est. primary completion date: March 22, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 65 Years

Eligibility

Inclusion Criteria:

• Between the ages of 30-65
• 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:

• Not being willing to participate in the study,
• 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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Periodontitis
• Type 2 Diabetes

Intervention

Procedure:
• 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.

Diagnostic Test:
• ELISA Test
C1P and PGE2 levels in saliva samples obtained, and will be examined by ELISA test.

Other:
• 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.

Diagnostic Test:
• HbA1c Level
Measurement of HbA1c levels from blood tests

Locations

Country	Name	City	State
Turkey	Ondokuz Mayis University	Samsun

Sponsors (1)

Lead Sponsor	Collaborator
Ondokuz Mayis University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PGE2 levels in saliva	Change in saliva PGE2 levels from baseline to 3 months after non-surgical periodontal treatment	baseline to 3 months after treatment
Primary	C1P levels in saliva	Change in saliva C1P levels from baseline to 3 months after non-surgical periodontal treatment	baseline to 3 months after treatment
Primary	HbA1c levels	Blood test in routine biochemistry laboratory for evaluation of the change in HbA1c levels of patients with type 2 diabetes from baseline to 3 months after non-surgical periodontal treatment	baseline to 3 months after treatment
Secondary	Plaque index (PI)	The changes in PI from baseline to 3 months after non-surgical periodontal treatment	baseline to 3 months after treatment
Secondary	Bleeding on probing index (BOP)	The changes in BOP from baseline to 3 months after non-surgical periodontal treatment	baseline to 3 months after treatment
Secondary	Gingival index (GI)	The changes in GI from baseline to 3 months after non-surgical periodontal treatment	baseline to 3 months after treatment
Secondary	Probing pocket depth	The changes in probing pocket depth from baseline to 3 months after non-surgical periodontal treatment	baseline to 3 months after treatment
Secondary	Clinical attachment level (CAL)	The changes in CAL from baseline to 3 months after non-surgical periodontal treatment	baseline to 3 months after treatment