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

Sponsor
Alexandria University (Other)
Overall Status
Completed
CT.gov ID
NCT05667051
Collaborator
(none)
42
Enrollment
1
Location
5.2
Actual Duration (Months)
8.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    42 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Cross-Sectional
    Official Title:
    Endocan Biomarker Level in Gingival Crevicular Fluid in Periodontitis Patients With Type 2 Diabetes Mellitus [A Comparative Cross-Sectional Study]
    Actual Study Start Date :
    Apr 5, 2022
    Actual Primary Completion Date :
    Sep 1, 2022
    Actual Study Completion Date :
    Sep 10, 2022

    Arms and Interventions

    Arm Intervention/Treatment
    Controlled type 2 diabetes mellitus
    Diabetes mellitus free patients

    Outcome Measures

    Primary Outcome Measures

    1. 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

    2. 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.

    3. 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.

    4. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    40 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Faculty of Dentistry, Alexandria University Alexandria Egypt 21527

    Sponsors and Collaborators

    • Alexandria University

    Investigators

    • Principal Investigator: Emad Ayyad, BDS, Faculty of Dentistry, Alexandria University, Egypt
    • Study Director: Maha Abou Khadr, PhD, Faculty of Dentistry, Alexandria University, Egypt
    • Study Chair: Mona Ayyad, PhD, Faculty of Medicine, Alexandria University, Egypt
    • Study Chair: Gillan El-Kimary, PhD, Faculty of Dentistry, Alexandria University, Egypt

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Emad Ayad, MSc candidate, Oral Medicine, Periodontology, Oral Diagnosis and Oral Radiology Department, Faculty of Dentistry, Alexandria University, Alexandria University
    ClinicalTrials.gov Identifier:
    NCT05667051
    Other Study ID Numbers:
    • #256
    First Posted:
    Dec 28, 2022
    Last Update Posted:
    Dec 28, 2022
    Last Verified:
    Dec 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Periodontitis
    Diabetes Mellitus
    Diabetes Mellitus, Type 2

    Study Results

    No Results Posted as of Dec 28, 2022