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

NCT05454059 | Completed

• 1 other identifier: 2020/598
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

saliva; prostaglandin e2; ceramide-1-phosphate; non-surgical periodontal treatment; phase I periodontal therapy; saliva biomarker; metabolic control; HbA1c; PGE2; C1P; periodontitis; type 2 diabetes mellitus

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (5)

• Plaque index (PI)

  baseline to 3 months after treatment

• Bleeding on probing index (BOP)

  baseline to 3 months after treatment

• Gingival index (GI)

  baseline to 3 months after treatment

• Probing pocket depth

  baseline to 3 months after treatment

• Clinical attachment level (CAL)

  baseline to 3 months after treatment

Study Arms (6)

Group 1 (HH)

ACTIVE COMPARATOR

17 systemically healthy + periodontally healthy (normoglycemic)

Diagnostic Test: ELISA Test; Other: Periodontal Examination; Other: Saliva Sample Collection

Group 2 (HP)

EXPERIMENTAL

17 systemic healthy + grade A periodontitis

Procedure: Non-surgical periodontal treatment; Diagnostic Test: ELISA Test; Other: Periodontal Examination; Other: Saliva Sample Collection

Group 3 (T2D+H)

ACTIVE COMPARATOR

17 T2DM (HbA1c\<%7) + periodontally healthy

Diagnostic Test: ELISA Test; Other: Periodontal Examination; Other: Saliva Sample Collection; Diagnostic Test: HbA1c Level

Group 4 (T2D+P)

EXPERIMENTAL

17 T2DM (HbA1c\<%7) + grade B periodontitis

Procedure: Non-surgical periodontal treatment; Diagnostic Test: ELISA Test; Other: Periodontal Examination; Other: Saliva Sample Collection; Diagnostic Test: HbA1c Level

Group 5 (T2D-H)

ACTIVE COMPARATOR

17 T2DM (HbA1c≥%7) + periodontally healthy

Diagnostic Test: ELISA Test; Other: Periodontal Examination; Other: Saliva Sample Collection; Diagnostic Test: HbA1c Level

Group 6 (T2D-P)

EXPERIMENTAL

17 T2DM (HbA1c≥%7) + grade C periodontitis

Procedure: Non-surgical periodontal treatment; Diagnostic Test: ELISA Test; Other: Periodontal Examination; Other: Saliva Sample Collection; Diagnostic Test: HbA1c Level

Interventions

Non-surgical periodontal treatment PROCEDURE

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.

Also known as: phase I periodontal therapy, scaling and root planing, full mouth debridement

Group 2 (HP); Group 4 (T2D+P); Group 6 (T2D-P)

ELISA Test DIAGNOSTIC_TEST

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

Group 1 (HH); Group 2 (HP); Group 3 (T2D+H); Group 4 (T2D+P); Group 5 (T2D-H); Group 6 (T2D-P)

Periodontal Examination OTHER

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.

Group 1 (HH); Group 2 (HP); Group 3 (T2D+H); Group 4 (T2D+P); Group 5 (T2D-H); Group 6 (T2D-P)

Saliva Sample Collection OTHER

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 1 (HH); Group 2 (HP); Group 3 (T2D+H); Group 4 (T2D+P); Group 5 (T2D-H); Group 6 (T2D-P)

HbA1c Level DIAGNOSTIC_TEST

Measurement of HbA1c levels from blood tests

Group 3 (T2D+H); Group 4 (T2D+P); Group 5 (T2D-H); Group 6 (T2D-P)

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Ondokuz Mayıs University: lead

Study Sites (1)

Ondokuz Mayis University

Samsun, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Periodontitis; Diabetes Mellitus, Type 2

Interventions

Tooth Exfoliation; Root Planing

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Dental Physiological Phenomena; Digestive System and Oral Physiological Phenomena; Dental Scaling; Dental Prophylaxis; Periodontics; Dentistry; Subgingival Curettage; Preventive Dentistry

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: A total of 102 (n=102) individuals were included in the study and were divided into 6 groups. The control groups of our study were Group 1 (HH), which included 17 both systemically healthy and periodontally healthy normoglycemic individuals, Group 2 (HP), which included 17 systemic healthy with Grade A periodontitis. Periodontally healthy T2DM patients were divided into two groups according to their HbA1c levels, and 17 patients with HbA1c levels below 7% were grouped as Group 3 (T2D+H), and 17 patients with HbA1c above 7% and 7% were grouped as Group 5 (T2D-H). 17 patients with T2DM with Grade B periodontitis with an HbA1c below 7% in the last three months were included in Group 4 (T2D+P), and 17 patients T2DM and periodontitis with an HbA1C value above 7% were included in Group 6 (T2D-P).

Study Record Dates

• First Submitted: July 1, 2022
• First Posted: July 12, 2022
• Study Start: October 22, 2020
• Primary Completion: March 22, 2022
• Study Completion: June 22, 2022
• Last Updated: July 12, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)