Evaluating non-surgical periodontal treatment's effects on the immune system by gender
Effect of Non-chirurgical Periodontal Treatment on the Innate and Adaptive Immunity From a Gender Perspective: Potential Therapeutic Implications of microRNAs
This study is testing how non-surgical treatment for gum disease affects the immune system in men and women with periodontitis, especially looking at how obesity plays a role.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 69 Years |
| Sex | All |
| Sponsor | Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana Academic / other |
| Locations | 2 sites (Valencia and 1 other locations) |
| Trial ID | NCT06261723 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the impact of non-surgical periodontal treatment on the immune response in men and women with periodontitis, considering the presence of obesity. Participants will receive treatment that includes oral health guidance and mechanical debridement, with blood, saliva, and gingival fluid samples collected at baseline and 12 weeks post-treatment. The study will analyze differences in immune response across four groups: obese women, non-obese women, obese men, and non-obese men, while also investigating specific microRNAs as potential biomarkers. The goal is to understand how gender and obesity influence treatment outcomes.
Who should consider this trial
Good fit: Ideal candidates include men and women diagnosed with periodontitis, with or without obesity.
Not a fit: Patients with fewer than fourteen teeth, infectious diseases, or other significant health issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved periodontal treatment strategies tailored to individual immune responses based on gender and obesity.
How similar studies have performed: While there is ongoing research in periodontal treatment and immune response, this specific approach considering gender and obesity is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Men/Women with periodontitis: * Periodontitis will be diagnosed according to the definition of the Centers for Disease Control and Prevention / American Academy of Periodontology (CDC/AAP). 2. Men/Women with obesity: * Body mass index (BMI) ≥30 kg/m2 (WHO 2000) Exclusion Criteria: * Having fewer than fourteen teeth, * Having infectious diseases * Having other oral inflammatory diseases, * Having received periodontal treatment in the past six months or antibiotics in the previous three months, undergoing systemic anti-inflammatory treatment, * Pregnancy or lactation * Serious illnesses, congenital adrenal hyperplasia, virilizing tumors, hypothyroidism, Cushing's syndrome, prolactinomas, cardiovascular diseases, or diabetes mellitus. * Alcohol or drug abuse * Psychiatric disorders.
Where this trial is running
Valencia and 1 other locations
- University Hospital Dr Peset — Valencia, Spain (Recruiting)
- University Hospital Dr. Peset — Valencia, Spain (Recruiting)
Study contacts
- Principal investigator: Milagros Rocha, PhD — Fisabio-Hospital Dr Peset
- Study coordinator: Sandra López, PhD
- Email: sandra.lopez@fisabio.es
- Phone: 0034 963 188 879
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.