Clinical trial NCT06306937: Serum Levels of Vitamin D and IL8 in Patients With Periodontitis
Official title: Serum Levels of Vitamin D and IL8 in Patients With Periodontitis: A Case-control Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Periodontal Diseases
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2024-03-12
Enrollment: 98
Sex: ALL
Minimum age (years): 21
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.

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.

Primary outcomes:
measure: Serum Levels of 25(OH)vitamin D
timeFrame: Laboratory evaluation after samples collection. it was performed in 1 month
measure: Serum Levels of IL8
timeFrame: Laboratory evaluation after samples collection. it was performed in 1 month
Secondary outcomes:
measure: Plaque Index (Pl)
timeFrame: 1 day (Periodontal evaluation was performed one time for every patient with withdrawal of blood sample)
measure: Clinical Attachment Loss (CAL)
timeFrame: 1 day (Periodontal evaluation was performed one time for every patient with withdrawal of blood sample)
measure: Probing Pocket Depth (PPD)
timeFrame: 1 day (Periodontal evaluation was performed one time for every patient with withdrawal of blood sample)
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Mansoura University, Faculty of Dentistry
state: Dakahlia
Study officials:
affiliation: Mansoura University, Faculty of Dentistry
name: Wafaa saleh, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: