Endocan Biomarker Level in Gingival Crevicular Fluid in Periodontitis Patients With Type 2 Diabetes Mellitus

Diabetes Mellitus Clinical Trial

Official title:

Endocan Biomarker Level in Gingival Crevicular Fluid in Periodontitis Patients With Type 2 Diabetes Mellitus [A Comparative Cross-Sectional Study]

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05667051
• Other study ID #: #256
• Status: Completed
• Start date: April 5, 2022
• Est. completion date: September 10, 2022

Study information

• Verified date: December 2022
• Source: Alexandria University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Aim of the current study was to evaluate Endocan biomarker level in gingival crevicular fluid of patients with stage 1 or 2 (mild to moderate) periodontitis with controlled type 2 diabetes mellitus (DM) and compare it to that in DM free periodontitis patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: September 10, 2022
• Est. primary completion date: September 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 65 Years

Eligibility

Inclusion Criteria:

• Probing pocket depths (PPD) = 5 mm.
• Clinical attachment level (CAL) = 4 mm.
• Type 2 DM, for at least the past 3 years.
• HbA1c = 7%.

Exclusion Criteria:

• Uncontrolled Diabetes Mellitus.
• Systemic antibiotic or anti-inflammatory medication use in the previous 2 months.
• Non-surgical periodontal therapy in the previous 6 months.
• Surgical periodontal therapy in the previous 12 months.
• Use of calcium channel blockers, phenytoin, or cyclosporine.
• Pregnancy.
• Smokers

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Periodontitis

Locations

Country	Name	City	State
Egypt	Faculty of Dentistry, Alexandria University	Alexandria

Sponsors (1)

Lead Sponsor	Collaborator
Alexandria University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Endocan level	Endocan level in gingival crevicular samples was assessed by commercially available ELISA kit (Bioneovan Co., Ltd, Elisa Human Endocan/esm-1 ELISA Kit. Beijing, China). Assays were performed according to the manufacturer's instructions. Color change will be measured with a microplate reader (Hellma GmbH & Co. KG. Müllheim, Germany) at 450 nm. Concentrations were determined based on the respective assay standard curve. All samples were run in duplicate and values will be averaged	Day 1
Primary	Pocket probing depth (PPD)	PPD was assessed at six different sites (mesio-buccal, mid-buccal, disto-buccal, mesio-lingual, mid-lingual, and disto-lingual) per tooth at all teeth present, except third molars. PPD was assessed using Williams calibrated periodontal probe and recordings were made to the nearest mm; observations close to 0.5 mm were rounded to the upper whole mm.	Day 1
Primary	Clinical Attachment Level (CAL)	CAL was assessed at six different sites (mesio-buccal, mid-buccal, disto-buccal, mesio-lingual, mid-lingual, and disto-lingual) per tooth at all teeth present, except third molars. CAL was assessed using Williams calibrated periodontal probe and recordings were made to the nearest mm; observations close to 0.5 mm were rounded to the upper whole mm.	Day 1
Primary	Percentage of bleeding on probing sites (BOP%)	BOP% was assessed at six different sites (mesio-buccal, mid-buccal, disto-buccal, mesio-lingual, mid-lingual, and disto-lingual) per tooth at all teeth present, except third molars. BOP% was assessed using Williams calibrated periodontal probe and the number of sites with BOP were divided by the total number of examined sites and multiplied by 100 to calculate the percentage	Day 1