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

Ondokuz Mayıs University

Status: Completed

Conditions: Periodontitis; Type 2 Diabetes

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

Study type: Interventional

Funder types: Other

Identifiers

NCT05454059

2020/598

Details and patient eligibility

About

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.

Enrollment: 102 patients

Sex: All

Ages: 30 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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102 participants in 6 patient groups

Group 1 (HH)

Active Comparator group

Description:

17 systemically healthy + periodontally healthy (normoglycemic)

Treatment:

Other: Periodontal Examination

Other: Saliva Sample Collection

Diagnostic Test: ELISA Test

Group 2 (HP)

Experimental group

Description:

17 systemic healthy + grade A periodontitis

Treatment:

Other: Periodontal Examination

Other: Saliva Sample Collection

Diagnostic Test: ELISA Test

Procedure: Non-surgical periodontal treatment

Group 3 (T2D+H)

Active Comparator group

Description:

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

Treatment:

Other: Periodontal Examination

Diagnostic Test: HbA1c Level

Other: Saliva Sample Collection

Diagnostic Test: ELISA Test

Group 4 (T2D+P)

Experimental group

Description:

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

Treatment:

Other: Periodontal Examination

Diagnostic Test: HbA1c Level

Other: Saliva Sample Collection

Diagnostic Test: ELISA Test

Procedure: Non-surgical periodontal treatment

Group 5 (T2D-H)

Active Comparator group

Description:

17 T2DM (HbA1c≥%7) + periodontally healthy

Treatment:

Other: Periodontal Examination

Diagnostic Test: HbA1c Level

Other: Saliva Sample Collection

Diagnostic Test: ELISA Test

Group 6 (T2D-P)

Experimental group

Description:

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

Treatment:

Other: Periodontal Examination

Diagnostic Test: HbA1c Level

Other: Saliva Sample Collection

Diagnostic Test: ELISA Test

Procedure: Non-surgical periodontal treatment