Serum Levels of Vitamin D and IL8 in Patients With Periodontitis

NCT ID: NCT06306937

Last Updated: 2024-03-12

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 98 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-09-01
• Study Completion Date: 2023-09-30

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.

Detailed Description

The primary objective of this study is to assess the levels of vitamin D and IL8 in the serum of individuals diagnosed with periodontitis and compare them with those of a healthy control group. The study also aims to establish correlations between these serum levels and the degree of periodontitis severity.

Two groups will be recruited: patients diagnosed with periodontitis and a control group consisting of individuals without periodontal disease.

The participants will be matched for age, gender, and other relevant demographic factors to minimize confounding variables.

Serum samples will be collected from both groups. Periodontitis severity will be determined using established clinical indices, such as probing depth, clinical attachment loss, and bleeding on probing.

Vitamin D levels in the serum will be measured using standardized laboratory techniques.

IL8 levels in the serum will also be quantified using appropriate assays. Statistical analyses will be performed to identify any significant correlations between vitamin D levels, IL8 levels, and the severity of periodontitis.

Subgroup analyses may be conducted to explore potential variations based on demographic factors or other relevant variables.

The study will adhere to ethical guidelines, ensuring participant confidentiality, informed consent, and responsible data handling.

The study anticipates finding associations or correlations between serum levels of vitamin D and IL8 and the severity of periodontitis. This information may contribute to a better understanding of the role of these factors in periodontal health and could have implications for future preventive and therapeutic strategies.

Conditions

Periodontal Diseases

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Evalution of serum levels of vitamin D and IL8

Intervention Type: 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

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.

Evalution of serum levels of vitamin D and IL8

Intervention Type: 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.

Interventions

Evalution of serum levels of vitamin D and IL8

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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Mansoura University

OTHER

Sponsor Role: lead

Responsible Party

Wafaa Saleh

Assistant professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Wafaa saleh, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Mansoura University, Faculty of Dentistry

Locations

Mansoura University, Faculty of Dentistry

Al Mansurah, Dakahlia Governorate, Egypt

Countries

Egypt

Other Identifiers

A24020822

Identifier Type: -

Identifier Source: org_study_id