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Association Between Periodontitis and Dry Eye Disease: A Cross-Sectional Study

Recruitingn/aAges 30 Years - 65 YearsAllUniversity of Sulaimani
NCT07873697 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

This study is aiming at exploring the association between periodontitis and dry eye disease, which are both chronic inflammatory diseases that might have common pathogenic mechanisms. It is a cross-sectional study being conducted on four specific groups: a healthy group, periodontitis only, dry eye disease only, and a group with both periodontitis and dry eye disease. For all individuals, both clinical periodontal and ophthalmic parameters and assessments are being recorded. The study also includes collection of both saliva and tear samples from all individuals for later analysis of inflammatory biomarkers. Saliva samples will be collected using the drooling method, while tear samples will be collected using Schirmer strips. The levels of specific inflammatory biomarkers, including interleukin-6 (IL-6), matrix metalloproteinases (MMPs), and tissue inhibitors of metalloproteinases (TIMPs)

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. 30 - 65 years of age. 2. Diagnosed with periodontitis according to clinical attachment loss (CAL) ≥3 mm at two or more non-adjacent sites and/or probing pocket depth (PPD) ≥4 mm. 3. Diagnosed with dry eye disease that meets 3 out of 4 of the following criteria: Ocular surface disease index score of more than 12, tear film break-up time of 10 s or less, Schirmer test results without anesthesia of less than 10 mm/5 min, and ocular surface staining with more than five corneal spots, more than nine conjunctival spots, or lid margin involvement greater than 2 mm in length and 25% in width. When both eyes fulfilled the criteria, the eye with the more severe disease was selected. If both eyes showed equal severity, one eye was randomly chosen. 4. Possessing more than 20 natural teeth. - Exclusion Criteria: 1. Individuals with diabetes mellitus, uveitis, conjunctivitis, or active ocular allergy. 2. Individuals receiving topical or systemic corticosteroid treatment or immunomodulatory therapy. Those with previous use of ocular medications other than artificial tears. Those who have undergone major ocular surgeries or have undergone ocular surgery in the previous 3 months; those who wear contact lenses; and individuals with proptosis or eyelid abnormalities, as well as individuals with a history of laser-assisted in situ keratomileusis (LASIK) surgery. 3. Smokers. 4. Received periodontal treatment and antibiotics within the past 3 months 5. Individuals with autoimmune diseases. 6. Individuals who are pregnant and/or lactating. 7. Individuals whose occupations involve prolonged screen exposure. -
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What it tests

  • Not listed
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Where

1 site
University of Sulaimani/College of Dentistry and Shahid Doctor Aso Hospital
Sulaymaniyah, Iraq
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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