Serum Levels of Vitamin D and IL8 in Patients With Periodontitis

Periodontal Diseases Clinical Trial

Official title:

Serum Levels of Vitamin D and IL8 in Patients With Periodontitis: A Case-control Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06306937
• Other study ID #: A24020822
• Status: Completed
• Start date: September 1, 2022
• Est. completion date: September 30, 2023

Study information

• Verified date: March 2024
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 98
• Est. completion date: September 30, 2023
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Periodontal Diseases
• Periodontitis

Intervention

Diagnostic Test:
• 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.

Locations

Country	Name	City	State
Egypt	Mansoura University, Faculty of Dentistry	Mansoura	Dakahlia

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Plaque Index (Pl)	Assessment of dental plaque presence and severity on a scale of 0 to 3.	1 day (Periodontal evaluation was performed one time for every patient with withdrawal of blood sample)
Secondary	Clinical Attachment Loss (CAL)	Measurement in millimeters from CEJ to the most apically probable portion.	1 day (Periodontal evaluation was performed one time for every patient with withdrawal of blood sample)
Secondary	Probing Pocket Depth (PPD)	Measurement in millimeters from the gingival margin to the most apically probable portion.	1 day (Periodontal evaluation was performed one time for every patient with withdrawal of blood sample)