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

Completed

• Conditions: Periodontitis; Diabetes Mellitus

• Registration Number: NCT05667051
• Lead Sponsor: Alexandria University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-04-05
• Primary Completion: 2022-09-01
• Study Completion: 2022-09-10
• Status Verified: 2022-12
• Study First Submitted: 2022-12-19
• Study First Submitted QC: 2022-12-19
• Last Update Submitted: 2022-12-19
• Study First Posted: 2022-12-28
• Last Update Posted: 2022-12-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pocket probing depth (PPD)	Day 1	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.
Clinical Attachment Level (CAL)	Day 1	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.
Endocan level	Day 1	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
Percentage of bleeding on probing sites (BOP%)	Day 1	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

Trial Locations

Locations (1)

Faculty of Dentistry, Alexandria University; 🇪🇬 Alexandria, Egypt