NCT05454059

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 102 (actual)
• Sponsor: Ondokuz Mayıs University · Academic / Other
• Sex: All
• Age: 30 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Periodontitis
• Type 2 Diabetes

Interventions

Type	Name	Description
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.
OTHER	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

Timeline

• Start date: 2020-10-22
• Primary completion: 2022-03-22
• Completion: 2022-06-22
• First posted: 2022-07-12
• Last updated: 2022-07-12

Locations

1 site across 1 country: Turkey (Türkiye)