Serum Levels of Vitamin D and IL8 in Patients With Periodontitis

NCT06306937 | Completed

• 1 other identifier: A24020822
• Study Type: observational
• Target: 98
• Locations: 1 country
• Sites: 1

Brief Summary

We evaluated vitamin D and IL8 levels in the serum of patients with periodontitis as well as the healthy controls to correlate their levels with the degree of periodontitis.

Conditions

Periodontal Diseases

Outcome Measures

Primary Outcomes (2)

• Serum Levels of 25(OH)vitamin D

  Measurement of vitamin D levels (categorized as deficient, inadequate, or adequate) using a commercial ELISA kit.

  Laboratory evaluation after samples collection. it was performed in 1 month

• Serum Levels of IL8

  Measurement of IL8 levels (expressed in pg/ml) using a commercial ELISA kit.

  Laboratory evaluation after samples collection. it was performed in 1 month

Secondary Outcomes (3)

• Plaque Index (Pl)

  1 day (Periodontal evaluation was performed one time for every patient with withdrawal of blood sample)

• Clinical Attachment Loss (CAL)

  1 day (Periodontal evaluation was performed one time for every patient with withdrawal of blood sample)

• Probing Pocket Depth (PPD)

  1 day (Periodontal evaluation was performed one time for every patient with withdrawal of blood sample)

Study Arms (2)

Periodontitis

Individuals diagnosed with periodontitis based on established clinical criteria. This group will include participants who exhibit signs and symptoms of periodontal disease, such as probing depth, clinical attachment loss, and bleeding on probing.

Diagnostic Test: Evalution of serum levels of vitamin D and IL8

Control

Individuals without any signs or history of periodontal disease. This group will consist of participants who do not have clinically diagnosed periodontitis and serve as the healthy control group for comparison with the periodontitis group.

Diagnostic Test: Evalution of serum levels of vitamin D and IL8

Interventions

Evalution of serum levels of vitamin D and IL8 DIAGNOSTIC_TEST

Group 1 (Periodontitis Group): The intervention involves observing and analyzing individuals diagnosed with periodontitis based on established clinical criteria. The focus is on assessing vitamin D and IL8 levels in the serum and correlating these levels with the severity of periodontitis, determined by clinical indices such as probing depth, clinical attachment loss, and bleeding on probing. Group 2 (Control Group): The intervention involves observing and analyzing individuals without any signs or history of periodontal disease. The focus is on assessing vitamin D and IL8 levels in the serum for comparison with the periodontitis group. This group serves as the healthy control for the study.

Control; Periodontitis

Eligibility Criteria

• Age: 21 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Periodontitis Group: Individuals diagnosed with periodontitis, meet specific criteria such as a minimum of 40% of sites with CAL ≥2 mm, PD ≥4 mm, and ≥40% of sites with bleeding on probing. This group represented individuals with varying degrees of periodontal disease. Control Group: Healthy individuals, age, and gender-matched, devoid of systemic diseases, and medications, and with no sites exhibiting PD ≥4 mm or CAL ≥4 mm. This group provided a baseline for periodontal health in the absence of diagnosed periodontitis. The study's observational design allowed for the comprehensive examination of these groups, shedding light on the interplay between serum biomarkers, vitamin D, IL8, and periodontal health in a real-world setting. Population diversity enhances the generalizability of findings beyond specific clinical or demographic subsets.

You may qualify if:

• presence of at least twenty teeth.
• Periodontitis patients with a minimum of 40% of sites with a clinical attachment level (CAL) ≥2 mm and probing depth (PD)≥4 mm.
• presence of ≥40% sites with bleeding on probing.
• Healthy individuals matched for age and gender, who presented no systemic disease, no drugs were taken, no sites with PD ≥4 mm or CAL ≥4 mm, or radiographic signs of bone loss were enrolled, such as a control group.

You may not qualify if:

• Intake of contraceptives, immunosuppressive, antibiotics or anti-inflammatory drugs throughout the last three months prior to the study.
• Pregnant and lactating females.
• Diabetic patients.
• History of medications that might affect bone and mineral metabolism and/or periodontal health.
• Taking multivitamins and food supplement which contain vitamin D.
• Malabsorption syndrome or patient with chronic diarrhea.
• Treatment with bisphosphonates in the past 12 months or lifetime exposure to bisphosphonates for more than 3 years.

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Mansoura University, Faculty of Dentistry

Al Mansurah, Dakahlia Governorate, 35516, Egypt

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

This study focuses on serum samples as the primary biospecimen, collected aseptically from individuals with and without periodontitis. Samples are meticulously labeled, processed through clotting and centrifugation, and stored at controlled temperatures in a secure bio-repository. The laboratory analysis will measure IL8 and vitamin D levels using standardized techniques. Each biospecimen is linked to participant data for correlation analysis, ensuring the integrity and confidentiality of the study's biospecimen collection and analysis process.

MeSH Terms

Conditions

Periodontal Diseases

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Study Officials

• Wafaa saleh, Ph.D

  Mansoura University, Faculty of Dentistry

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: March 6, 2024
• First Posted: March 12, 2024
• Study Start: September 1, 2022
• Primary Completion: September 30, 2023
• Study Completion: September 30, 2023
• Last Updated: March 12, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)