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RecruitingNCT07873697Updated Oct 14, 2026

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

An observational study in Periodontitis and Dry Eye Disease (DED), sponsored by University of Sulaimani. Recruiting at 1 site in Iraq. Open to participants aged 30 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-14.

Sponsored by University of Sulaimani · Observational

From the registry’s dates

  • Started Apr 2026; still recruiting 6 months later.
Updated Oct 14, 2026Newly registeredGo to Updates ↓
Study type
Observational
Model
Other
Time perspective
Cross-sectional
Enrollment
80
Ages
30 Years to 65 Years
Sex
All
01

Study summary

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), will be investigated using ELISA. The study aims to investigate the association between periodontal and ocular surface inflammation as well as investigate the common inflammatory pathways for both periodontitis and dry eye disease. These investigations might contribute to a better understanding of the systemic correlation that links both periodontal and ocular health.

Read the detailed description

Periodontitis and dry eye disease are both multifactorial chronic inflammatory diseases that can affect the quality of life and are significantly recognized for their systemic associations. Periodontitis is an inflammatory disease mainly induced by a dental biofilm and characterized by progressive destruction of the supporting structures surrounding the teeth, as well as being mediated by the host's immune response. Similarly, dry eye disease is the inflammation of the ocular surface characterized by tear film instability, hyperosmolarity, and ocular surface inflammation, resulting in discomfort and visual disturbance. Both diseases involve complex inflammatory pathways and the release of pro-inflammatory mediators that may contribute to tissue damage locally and might exert systemic effects as well.

Studies suggest that periodontal health may affect extra-oral conditions through shared inflammatory mechanisms, yet the relationship between periodontitis and dry eye disease remains unknown or not sufficiently investigated. However, inflammatory biomarkers such as interleukin-6 (IL-6), matrix metalloproteinases (MMPs), and tissue inhibitors of metalloproteinases (TIMPs) have been implicated in the pathogenesis of both diseases. These biomarkers play important roles in the host's immune regulation; as a result, they can be used for exploring the association between periodontitis and dry eye diseases.

This study is designed to investigate the association between periodontitis and dry eye disease through both performing clinical assessments and performing biochemical analysis. Both saliva and tear samples will be collected using non-invasive methods to avoid discomfort for the participants. Saliva will be collected using the drooling method, while tear samples will be collected using Schirmer strips. The collected samples will later be analyzed by the use of ELISA to evaluate the levels of the inflammatory biomarkers.

In addition to biomarker analysis, clinical evaluations will be performed to assess periodontal health and ocular surface condition using standardized diagnostic examinations. This integration can enhance the exploration of the association between the two diseases.

The significance of this study lies in its ability to investigate whether an association exists between periodontitis and dry eye disease. Identifying such an association could have important implications for interdisciplinary healthcare, making the collaboration between dental and ophthalmologic practitioners significant. Moreover, the investigations might participate in the development of novel diagnostic markers and management strategies targeting systemic inflammation. This research may also provide a foundation for future longitudinal and interventional studies exploring causal relationships and therapeutic outcomes.

02

Conditions studied

  • Periodontitis
  • Dry Eye Disease (DED)

Keywords

  • periodontitis
  • dry eye disease
  • Interlukin-6
  • Matrix Metalloproteinase
  • Tissue Inhibitor of Metalloproteinases
03

In context

Periodontitis

1,664 studies on the registry are indexed under Periodontitis; 328 are open to participants now.

This study's planned enrollment of 80 is below the median of 89 across 441 observational studies indexed under Periodontitis.

Browse Periodontitis studies →

Lead sponsor

University of Sulaimani is the lead sponsor of 17 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

The study population includes adult participants collected from dental and ophthalmology hospitals. The population will include both healthy individuals and patients diagnosed with periodontal disease and/or dry eye disease. Participants will undergo specific periodontal and ocular health examinations to allow for analysis. Individuals will be categorized into groups, including healthy controls, those with periodontitis only, those with dry eye disease only, and those presenting with both diseases. These different populations will enable the evaluation of the associations between periodontal and ocular inflammatory conditions.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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. -
05

Study design

Observational model
Other
Time perspective
Cross-sectional
Enrollment
80 participants (estimated)
Target follow-up
1 Day
Patient registry
Yes

Groups and cohorts

  • Group A : Healthy controls

    Including 20 individuals with no clinical signs of periodontitis or dry eye disease.

  • Group B: Periodontitis only

    Including 20 individuals diagnosed with periodontitis only.

  • Group C: Dry eye disease only

    Including 20 individuals diagnosed with dry eye disease only.

  • Group D: Both diseases

    Including 20 individuals diagnosed with both periodontitis and dry eye disease.

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What researchers measure

Primary outcomes

  1. Probing pocket depth

    Time frame: At baseline

Secondary outcomes

  1. Clinical periodontal parameters, clinical ocular parameters, and the levels of inflammatory biomarkers in saliva and tear samples.

    Clinical periodontal parameters (clinical attachment loss, plaque index, and bleeding index); clinical ocular parameters (ocular surface disease index, tear break-up time, conjunctival and corneal staining, Schirmer test without anesthesia, and Meibomian gland examination); and the levels of inflammatory biomarkers in saliva and tear samples.

    Time frame: At baseline

07

Study locations

1 of 1 sites recruiting
  • University of Sulaimani/College of Dentistry and Shahid Doctor Aso Hospital
    Sulaymaniyah, As Sulaymaniyah Governorate, Iraq
    • Razha Sirwan Hamaali, BDS · Contact · razha.hamaali@univsul.edu.iq · +9647705008668
    • Sarhang Sarwat Gul, BDS, MSc, PhD · Contact · sarhang.hama@univsul.edu.iq · +9647701447723
    • Razha Sirwan Hamaali, BDS · Principal investigator
    • Sahang Sarwat Gul, BDS, MSc, PhD · Principal investigator
    • Tara Mahmood Hassan, MBChB, MSc, PhD · Principal investigator
    Recruiting
08

References and documents

Publications

  • Huang ST, Wang YH, Chang KS, Chang YC. Increased risk of dry eye disease in Taiwanese patients with chronic periodontitis: A nationwide population-based cohort study. J Dent Sci. 2026 Apr 1;21(2):1120-1126. doi: 10.1016/j.jds.2025.12.020. eCollection 2026. PubMed 42688729 ↗

Individual participant data

Plan to share: No

09

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Oct 14, 2026
Show all 1 update
  1. Oct 14, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07873697
Lead sponsor
University of Sulaimani
Responsible party
Razha Sirwan Hamaali (Postgraduate Master's Student, University of Sulaimani) — Principal investigator
First posted
Oct 14, 2026
Start date
Apr 1, 2026
Primary completion
Nov 2026 (estimated)
Completion
Nov 2026 (estimated)
Last update
Oct 14, 2026

Study contacts

Razha Sirwan Hamaali, Bachelor of Dental Surgery
Contact
razha.hamaali@univsul.edu.iq
+9647705008668
Assist. Prof. Dr. Sarhang Sarwat Gul
Contact
sarhang.hama@univsul.edu.iq
+9647701447723
Sarhang Sarwat Gul, BDS, MSc, PhD
principal investigator · University of Sulaimani
Tara Mahmood Hassan, MBChB, MSc, PhD
principal investigator · University of Sulaimani

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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