PeriodontitisNCT07873697
Association Between Periodontitis and Dry Eye Disease: A Cross-Sectional Study
An observational study of Periodontitis and Dry Eye Disease (DED), run by University of Sulaimani at 1 site in Iraq.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontitis, Dry Eye Disease (DED)
- How many people
- 80 participants
- Where
- 1 siteIraq
- Study dates
- 1 Apr 2026to Nov 2026
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 30 - 65 years of age.
- 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.
- 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.
- Possessing more than 20 natural teeth. -
Who cannot join
- Individuals with diabetes mellitus, uveitis, conjunctivitis, or active ocular allergy.
- 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.
- Smokers.
- Received periodontal treatment and antibiotics within the past 3 months
- Individuals with autoimmune diseases.
- Individuals who are pregnant and/or lactating.
- Individuals whose occupations involve prolonged screen exposure. -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Iraq1 site, 1 recruiting
- Recruiting
University of Sulaimani/College of Dentistry and Shahid Doctor Aso Hospital
Sulaymaniyah, As Sulaymaniyah Governorate
Razha Sirwan Hamaali, BDS, +9647705008668, razha.hamaali@univsul.edu.iq
Sarhang Sarwat Gul, BDS, MSc, PhD, +9647701447723, sarhang.hama@univsul.edu.iq
About this study
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.
- Conditions
- Periodontitis, Dry Eye Disease (DED)
- Keywords
- periodontitis, dry eye disease, Interlukin-6, Matrix Metalloproteinase, Tissue Inhibitor of Metalloproteinases
- Medical subject headings
- Periodontitis, Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Probing pocket depth
Measured: 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.
Measured: At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2026
- Study start1 Apr 2026
- Primary completionNov 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PeriodontitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 80 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- University of Sulaimani
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Razha Sirwan Hamaali, University of Sulaimani
- Investigators
- Sarhang Sarwat Gul, BDS, MSc, PhD, Principal investigator, University of SulaimaniTara Mahmood Hassan, MBChB, MSc, PhD, Principal investigator, University of Sulaimani
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07873697
- Sponsor's protocol ID
- COD-EC-26-0150
- Status last verified
- Jan 2026
- First submitted
- 7 Oct 2026
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Periodontitis and Dry Eye Disease: A Cross-Sectional Study
- ClinicalTrials.gov ID
- NCT07873697
- Acronym / sponsor ID
- COD-EC-26-0150
- Conditions
- Periodontitis, Dry Eye Disease (DED)
- Keywords
- periodontitis, dry eye disease, Interlukin-6, Matrix Metalloproteinase, Tissue Inhibitor of Metalloproteinases
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of SulaimaniUniversity, hospital or other
- Study start
- 1 Apr 2026 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 14 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 30 - 65 years of age.
- 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.
- 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.
- Possessing more than 20 natural teeth. -
Key exclusion criteria (7 listed)
- Individuals with diabetes mellitus, uveitis, conjunctivitis, or active ocular allergy.
- 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.
- Smokers.
- Received periodontal treatment and antibiotics within the past 3 months
- Individuals with autoimmune diseases.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Probing pocket depth
Time frame: At baseline
1 secondary outcome
Clinical periodontal parameters, clinical ocular parameters, and the levels of inflammatory biomarkers in saliva and tear samples.
Time frame: At baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2026.
- Background: PubMed 42688729Huang 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sarhang Sarwat Gul, BDS, MSc, PhD principal investigator
University of Sulaimani
Tara Mahmood Hassan, MBChB, MSc, PhD principal investigator
University of Sulaimani
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Periodontitis and Dry Eye Disease (DED), run by University of Sulaimani at 1 site in Iraq.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iraq. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Razha Sirwan Hamaali, Bachelor of Dental Surgery (+9647705008668, razha.hamaali@univsul.edu.iq), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Probing pocket depth (time frame: At baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07873697, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2026.