Serum Levels of Vitamin D and IL8 in Patients With Periodontitis

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

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.

Study Overview

• Status: Completed
• Conditions: Periodontal Diseases
• Intervention / Treatment: Diagnostic test: Evalution of serum levels of vitamin D and IL8

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.

• Study Type: Observational
• Enrollment (Actual): 98

Contacts and Locations

Study Locations

• Egypt
  • Dakahlia
    • Mansoura, Dakahlia, Egypt, 35516
      • Mansoura University, Faculty of Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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)

Collaborators and Investigators

• Sponsor: Mansoura University
• Investigators: Principal Investigator: Wafaa saleh, Ph.D, Mansoura University, Faculty of Dentistry

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2022
• Primary Completion (Actual): September 30, 2023
• Study Completion (Actual): September 30, 2023

Study Registration Dates

• First Submitted: March 6, 2024
• First Submitted That Met QC Criteria: March 11, 2024
• First Posted (Actual): March 12, 2024

Study Record Updates

• Last Update Posted (Actual): March 12, 2024
• Last Update Submitted That Met QC Criteria: March 11, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Mouth Diseases; Periodontitis; Periodontal Diseases; Physiological Effects of Drugs; Micronutrients; Vitamins; Bone Density Conservation Agents; Vitamin D
• Other Study ID Numbers: A24020822

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No