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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05667051
Other study ID # #256
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


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
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