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NCT Number: NCT05667051

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

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.

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Key information

Conditions

Periodontitis Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Mouth Diseases Nutritional and Metabolic Diseases Periodontal Diseases Stomatognathic Diseases

Age range

40 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Faculty of Dentistry, Alexandria University

Alexandria, 21527, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Endocan level

    Time frame: 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)

    Time frame: 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)

    Time frame: 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%)

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Alexandria University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Dec 28, 2022
Registry last updated
Dec 28, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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