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

Not Applicable

Completed

• Conditions: Type 2 Diabetes; Periodontitis
• Interventions: Procedure: Non-surgical periodontal treatment; Diagnostic Test: ELISA Test; Other: Saliva Sample Collection; Other: Periodontal Examination; Diagnostic Test: HbA1c Level

• Registration Number: NCT05454059
• Lead Sponsor: Ondokuz Mayıs University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-10-22
• Primary Completion: 2022-03-22
• Study Completion: 2022-06-22
• Status Verified: 2022-07
• Study First Submitted: 2022-07-01
• Study First Submitted QC: 2022-07-06
• Last Update Submitted: 2022-07-06
• Study First Posted: 2022-07-12
• Last Update Posted: 2022-07-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 102

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 6 (T2D-P)	ELISA Test	17 T2DM (HbA1c≥%7) + grade C periodontitis
Group 5 (T2D-H)	Saliva Sample Collection	17 T2DM (HbA1c≥%7) + periodontally healthy
Group 2 (HP)	Non-surgical periodontal treatment	17 systemic healthy + grade A periodontitis
Group 1 (HH)	ELISA Test	17 systemically healthy + periodontally healthy (normoglycemic)
Group 2 (HP)	ELISA Test	17 systemic healthy + grade A periodontitis
Group 2 (HP)	Periodontal Examination	17 systemic healthy + grade A periodontitis
Group 3 (T2D+H)	Periodontal Examination	17 T2DM (HbA1c\<%7) + periodontally healthy
Group 5 (T2D-H)	ELISA Test	17 T2DM (HbA1c≥%7) + periodontally healthy
Group 1 (HH)	Periodontal Examination	17 systemically healthy + periodontally healthy (normoglycemic)
Group 2 (HP)	Saliva Sample Collection	17 systemic healthy + grade A periodontitis
Group 4 (T2D+P)	Non-surgical periodontal treatment	17 T2DM (HbA1c\<%7) + grade B periodontitis
Group 4 (T2D+P)	Periodontal Examination	17 T2DM (HbA1c\<%7) + grade B periodontitis
Group 1 (HH)	Saliva Sample Collection	17 systemically healthy + periodontally healthy (normoglycemic)
Group 3 (T2D+H)	ELISA Test	17 T2DM (HbA1c\<%7) + periodontally healthy
Group 4 (T2D+P)	ELISA Test	17 T2DM (HbA1c\<%7) + grade B periodontitis
Group 4 (T2D+P)	HbA1c Level	17 T2DM (HbA1c\<%7) + grade B periodontitis
Group 5 (T2D-H)	HbA1c Level	17 T2DM (HbA1c≥%7) + periodontally healthy
Group 6 (T2D-P)	Saliva Sample Collection	17 T2DM (HbA1c≥%7) + grade C periodontitis
Group 3 (T2D+H)	HbA1c Level	17 T2DM (HbA1c\<%7) + periodontally healthy
Group 6 (T2D-P)	Periodontal Examination	17 T2DM (HbA1c≥%7) + grade C periodontitis
Group 6 (T2D-P)	HbA1c Level	17 T2DM (HbA1c≥%7) + grade C periodontitis
Group 3 (T2D+H)	Saliva Sample Collection	17 T2DM (HbA1c\<%7) + periodontally healthy
Group 4 (T2D+P)	Saliva Sample Collection	17 T2DM (HbA1c\<%7) + grade B periodontitis
Group 5 (T2D-H)	Periodontal Examination	17 T2DM (HbA1c≥%7) + periodontally healthy
Group 6 (T2D-P)	Non-surgical periodontal treatment	17 T2DM (HbA1c≥%7) + grade C periodontitis

Primary Outcome Measures

Name	Time	Method
PGE2 levels in saliva	baseline to 3 months after treatment	Change in saliva PGE2 levels from baseline to 3 months after non-surgical periodontal treatment
C1P levels in saliva	baseline to 3 months after treatment	Change in saliva C1P levels from baseline to 3 months after non-surgical periodontal treatment
HbA1c levels	baseline to 3 months after treatment	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

Secondary Outcome Measures

Name	Time	Method
Bleeding on probing index (BOP)	baseline to 3 months after treatment	The changes in BOP from baseline to 3 months after non-surgical periodontal treatment
Gingival index (GI)	baseline to 3 months after treatment	The changes in GI from baseline to 3 months after non-surgical periodontal treatment
Probing pocket depth	baseline to 3 months after treatment	The changes in probing pocket depth from baseline to 3 months after non-surgical periodontal treatment
Clinical attachment level (CAL)	baseline to 3 months after treatment	The changes in CAL from baseline to 3 months after non-surgical periodontal treatment
Plaque index (PI)	baseline to 3 months after treatment	The changes in PI from baseline to 3 months after non-surgical periodontal treatment

Trial Locations

Locations (1)

Ondokuz Mayis University; 🇹🇷 Samsun, Turkey