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

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.

Study Overview

• Status: Completed
• Conditions: Periodontitis; Type 2 Diabetes
• Intervention / Treatment: Diagnostic test: ELISA Test; Other: Periodontal Examination; Other: Saliva Sample Collection; Procedure: Non-surgical periodontal treatment; Diagnostic test: HbA1c Level

• Study Type: Interventional
• Enrollment (Actual): 102
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Samsun, Turkey
    • Ondokuz Mayis University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Group 1 (HH); 17 systemically healthy + periodontally healthy (normoglycemic)	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.
EXPERIMENTAL: Group 2 (HP); 17 systemic healthy + grade A periodontitis	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.; 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.; Other Names: phase I periodontal therapy; scaling and root planing; full mouth debridement
ACTIVE_COMPARATOR: Group 3 (T2D+H); 17 T2DM (HbA1c<%7) + periodontally healthy	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
EXPERIMENTAL: Group 4 (T2D+P); 17 T2DM (HbA1c<%7) + grade B periodontitis	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.; 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.; Other Names: phase I periodontal therapy; scaling and root planing; full mouth debridement; Diagnostic test: HbA1c Level; Measurement of HbA1c levels from blood tests
ACTIVE_COMPARATOR: Group 5 (T2D-H); 17 T2DM (HbA1c≥%7) + periodontally healthy	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
EXPERIMENTAL: Group 6 (T2D-P); 17 T2DM (HbA1c≥%7) + grade C periodontitis	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.; 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.; Other Names: phase I periodontal therapy; scaling and root planing; full mouth debridement; Diagnostic test: HbA1c Level; Measurement of HbA1c levels from blood tests

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plaque index (PI)	The changes in PI from baseline to 3 months after non-surgical periodontal treatment	baseline to 3 months after treatment
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
Gingival index (GI)	The changes in GI from baseline to 3 months after non-surgical periodontal treatment	baseline to 3 months after treatment
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
Clinical attachment level (CAL)	The changes in CAL from baseline to 3 months after non-surgical periodontal treatment	baseline to 3 months after treatment

Collaborators and Investigators

• Sponsor: Ondokuz Mayıs University

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 22, 2020
• Primary Completion (ACTUAL): March 22, 2022
• Study Completion (ACTUAL): June 22, 2022

Study Registration Dates

• First Submitted: July 1, 2022
• First Submitted That Met QC Criteria: July 6, 2022
• First Posted (ACTUAL): July 12, 2022

Study Record Updates

• Last Update Posted (ACTUAL): July 12, 2022
• Last Update Submitted That Met QC Criteria: July 6, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: HbA1c; metabolic control; type 2 diabetes mellitus; periodontitis; saliva; PGE2; non-surgical periodontal treatment; prostaglandin e2; ceramide-1-phosphate; phase I periodontal therapy; saliva biomarker; C1P
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Diabetes Mellitus, Type 2; Periodontitis
• Other Study ID Numbers: 2020/598

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No