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

NCT05667051 | Completed

• 1 other identifier: #256
• Study Type: observational
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Periodontitis; Diabetes Mellitus

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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

Study Arms (2)

Controlled type 2 diabetes mellitus

Diabetes mellitus free patients

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with stage 1 or 2 (mild to moderate) periodontitis having ≤ 4 mm attachment loss at least in one site were included in the study these were divided into two groups, with controlled type 2 diabetes mellitus, and systemically healthy stage 1 or 2 (mild to moderate) periodontitis patients

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

Faculty of Dentistry, Alexandria University

Alexandria, 21527, Egypt

Location

MeSH Terms

Conditions

Periodontitis; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Emad Ayyad, BDS

  Faculty of Dentistry, Alexandria University, Egypt

  PRINCIPAL INVESTIGATOR

• Maha Abou Khadr, PhD

  Faculty of Dentistry, Alexandria University, Egypt

  STUDY DIRECTOR

• Mona Ayyad, PhD

  Faculty of Medicine, Alexandria University, Egypt

  STUDY CHAIR

• Gillan El-Kimary, PhD

  Faculty of Dentistry, Alexandria University, Egypt

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MSc candidate, Oral Medicine, Periodontology, Oral Diagnosis and Oral Radiology Department, Faculty of Dentistry, Alexandria University

Study Record Dates

• First Submitted: December 19, 2022
• First Posted: December 28, 2022
• Study Start: April 5, 2022
• Primary Completion: September 1, 2022
• Study Completion: September 10, 2022
• Last Updated: December 28, 2022

Record last verified: 2022-12

Locations

EG (1)