Association Between Periodontitis and Dry Eye Disease in Adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This cross-sectional study collects clinical dental and eye assessments from four groups: healthy individuals, periodontitis-only, dry eye-only, and both conditions. Saliva and tear samples are analyzed for inflammatory biomarkers such as IL-6, MMPs, and TIMPs using ELISA to explore potential shared inflammatory pathways. The goal is to understand whether systemic inflammation connects periodontal and ocular surface diseases. Enrollment targets adults aged 30–65 with specific dental and ocular criteria, excluding those with diabetes or active ocular allergies, and those on corticosteroids. Data from this study may clarify associations and guide future research on shared mechanisms.

Why it matters

Who can join: the full rules

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. -

Where it's running

• University of Sulaimani/College of Dentistry and Shahid Doctor Aso Hospital
  Sulaymaniyah, As Sulaymaniyah Governorate, Iraq Recruiting

Study contacts

• Principal investigator: Sarhang Sarwat Gul, BDS, MSc, PhD — University of Sulaimani
• Study coordinator: Razha Sirwan Hamaali, Bachelor of Dental Surgery
• Email: razha.hamaali@univsul.edu.iq
• Phone: +9647705008668

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.