Periodontal DiseasesNCT07856901
Retinal and Choroidal Changes in Periodontal Disease
An observational study of Periodontal Diseases and Periodontal Diseases Inflammation, run by Zeliha Başak Çakır Erdil at 1 site in Turkey (Türkiye).
Trial summary
Advanced PeriodontitisIn this cross-sectional study, the relationship between periodontal disease severity and retinal and choroidal structural changes was evaluated using SD-OCT. Data from a total of 80 participants were examined. Read more about this study
- Who is it for?
- Ages 20 to 54 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontal Diseases, Periodontal Diseases Inflammation, Retinal Thickening
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Oct 2026to Oct 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 20 to 54 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: The study population consisted of 80 systemically healthy, non-smoking adults who underwent comprehensive periodontal examination and spectral-domain optical coherence tomography (SD-OCT). Participants were classified into four groups according to their periodontal status (periodontally healthy, gingivitis, early periodontitis, and advanced periodontitis). All participants provided written informed consent before enrollment.
Who may be able to join
- Systemically healthy adults. Non-smokers (no current or previous tobacco use). Participants who underwent optical coherence tomography (OCT) imaging. Participants who provided written informed consent and agreed to participate in the study.
Who cannot join
- Presence of any systemic disease. Current or former smokers. Participants with incomplete clinical or OCT data. Individuals who did not provide written informed consent.
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Metin Çalışır, Prof.DR contact
Turkey (Türkiye)1 site
Faculty of Dentistry, Adıyaman University
Adıyaman, Adıyaman Province, 02030
Zeliha B ERDİL, DDS, 05059444038, bskcakirr@gmail.com
About this study
Official title: RETİNAL AND CHOROİDAL STRUCTURAL ALTERATİONS ACROSS THE PERİODONTAL DİSEASE CONTİNUUM: A CROSS-SECTİONAL OBSERVATİONAL STUDY
Advanced PeriodontitisIn this cross-sectional study, the relationship between periodontal disease severity and retinal and choroidal structural changes was evaluated using SD-OCT. Data from a total of 80 participants were examined. It was found that choroidal thickness increased and ganglion cell layer thickness decreased as periodontal disease severity increased, while no significant relationship was found in RNFL and IPL thicknesses. The findings support a possible association between periodontal disease and ocular structural changes.
Read the detailed description
Periodontal disease, by causing chronic inflammation, can affect not only oral tissues but also systemic organs. While the potential link between periodontal disease and eye diseases has attracted attention in recent years, data regarding retinal and choroidal structural changes are limited. In this study, periodontal clinical findings were compared with measurements of retinal nerve fiber layer (RNFL), ganglion cell layer (GCL), inner plexiform layer (IPL), and choroid thickness obtained using spectral-domain optical coherence tomography (SD-OCT) in a total of 80 individuals diagnosed with periodontal health, gingivitis, early periodontitis, and advanced periodontitis. The findings showed that choroidal thickness increased and GCL thickness decreased as the severity of periodontal disease increased. This study aims to contribute to a better understanding of the relationship between periodontal disease and ocular structural changes and to provide a basis for future prospective research.
Group 1: Periodontal Healthy
Participants with clinically healthy periodontal tissues and no evidence of gingivitis or periodontitis.
Group 2: Gingivitis
Participants diagnosed with gingivitis, presenting gingival inflammation without clinical attachment loss.
Group 3: Early Periodontitis
Participants diagnosed with early-stage periodontitis based on clinical periodontal examination.
Group 4: Advanced Periodontitis
Participants diagnosed with advanced periodontitis with greater periodontal tissue destruction.
- Keywords
- Retinal degeneration ; Tomography, Optical Coherence ; Periodontitis ; gingivitis; Retinal Ganglion Cells ; Periodontal Index
- Medical subject headings
- Periodontal Diseases, Retinal Degeneration, Periodontitis, Gingivitis
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 |
|---|---|---|
| Periodontal Healthy | Not described | |
| Gingivitis | Not described | |
| Early Periodontitis | Not described | |
| Advanced Periodontitis | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation Between Periodontal Disease Severity and Choroidal Thickness
The correlation between periodontal disease severity and choroidal thickness will be assessed using Spearman's correlation coefficient (rₛ). Periodontal disease severity will be assessed using probing pocket depth (PPD) and clinical attachment level (CAL), measured in millimeters (mm) using a periodontal probe. Choroidal thickness will be measured in micrometers (µm) using spectral-domain optical coherence tomography (SD-OCT).
Measured: Baseline
Secondary outcomes (3)
Correlation Between Periodontal Disease Severity and Retinal Nerve Fiber Layer (RNFL) Thickness
The correlation between periodontal disease severity and retinal nerve fiber layer (RNFL) thickness will be evaluated. Periodontal disease severity will be assessed using clinical periodontal parameters, including probing pocket depth (PPD) and clinical attachment level (CAL), measured in millimeters (mm). RNFL thickness will be measured in micrometers (µm) using spectral-domain optical coherence tomography (SD-OCT). The correlation will be quantified using Spearman's correlation coefficient (rₛ).
Measured: Baseline
Correlation Between Periodontal Disease Severity and Ganglion Cell Layer (GCL) Thickness
The correlation between periodontal disease severity and ganglion cell layer (GCL) thickness will be evaluated. Periodontal disease severity will be assessed using clinical periodontal parameters, including probing pocket depth (PPD) and clinical attachment level (CAL), measured in millimeters (mm). GCL thickness will be measured in micrometers (µm) using spectral-domain optical coherence tomography (SD-OCT). The correlation will be quantified using Spearman's correlation coefficient (rₛ).
Measured: Baseline
Correlation Between Periodontal Disease Severity and Inner Plexiform Layer (IPL) Thickness
The correlation between periodontal disease severity and inner plexiform layer (IPL) thickness will be evaluated. Periodontal disease severity will be assessed using clinical periodontal parameters, including probing pocket depth (PPD) and clinical attachment level (CAL), measured in millimeters (mm). IPL thickness will be measured in micrometers (µm) using spectral-domain optical coherence tomography (SD-OCT). The correlation will be quantified using Spearman's correlation coefficient (rₛ).
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2026
- Study startOct 2026 (estimated)
- Primary completionOct 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontal DiseasesStudies 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
- Zeliha Başak Çakır Erdil
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zeliha Başak Çakır Erdil, Adiyaman University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07856901
- Sponsor's protocol ID
- HÜ-KAEK-2026-00255
- Status last verified
- Sep 2026
- First submitted
- 22 Jul 2026
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared to protect participant confidentiality and privacy.
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RETİNAL AND CHOROİDAL STRUCTURAL ALTERATİONS ACROSS THE PERİODONTAL DİSEASE CONTİNUUM: A CROSS-SECTİONAL OBSERVATİONAL STUDY
- ClinicalTrials.gov ID
- NCT07856901
- Acronym / sponsor ID
- HÜ-KAEK-2026-00255
- Keywords
- Retinal degeneration ; Tomography, Optical Coherence ; Periodontitis ; gingivitis; Retinal Ganglion Cells ; Periodontal Index
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Zeliha Başak Çakır ErdilUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 5 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.
Advanced PeriodontitisIn this cross-sectional study, the relationship between periodontal disease severity and retinal and choroidal structural changes was evaluated using SD-OCT. Data from a total of 80 participants were examined. It was found that choroidal thickness increased and ganglion cell layer thickness decreased as periodontal disease severity increased, while no significant relationship was found in RNFL and IPL thicknesses. The findings support a possible association between periodontal disease and ocular structural changes.
Detailed description
Periodontal disease, by causing chronic inflammation, can affect not only oral tissues but also systemic organs. While the potential link between periodontal disease and eye diseases has attracted attention in recent years, data regarding retinal and choroidal structural changes are limited. In this study, periodontal clinical findings were compared with measurements of retinal nerve fiber layer (RNFL), ganglion cell layer (GCL), inner plexiform layer (IPL), and choroid thickness obtained using spectral-domain optical coherence tomography (SD-OCT) in a total of 80 individuals diagnosed with periodontal health, gingivitis, early periodontitis, and advanced periodontitis. The findings showed that choroidal thickness increased and GCL thickness decreased as the severity of periodontal disease increased. This study aims to contribute to a better understanding of the relationship between periodontal disease and ocular structural changes and to provide a basis for future prospective research.
Group 1: Periodontal Healthy
Participants with clinically healthy periodontal tissues and no evidence of gingivitis or periodontitis.
Group 2: Gingivitis
Participants diagnosed with gingivitis, presenting gingival inflammation without clinical attachment loss.
Group 3: Early Periodontitis
Participants diagnosed with early-stage periodontitis based on clinical periodontal examination.
Group 4: Advanced Periodontitis
Participants diagnosed with advanced periodontitis with greater periodontal tissue destruction.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Periodontal Healthy | – | – |
| Gingivitis | – | – |
| Early Periodontitis | – | – |
| Advanced Periodontitis | – | – |
Who may qualify
- Ages
- 20 to 54 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The study population consisted of 80 systemically healthy, non-smoking adults who underwent comprehensive periodontal examination and spectral-domain optical coherence tomography (SD-OCT). Participants were classified into four groups according to their periodontal status (periodontally healthy, gingivitis, early periodontitis, and advanced periodontitis). All participants provided written informed consent before enrollment.
Key inclusion criteria (1 listed)
- Systemically healthy adults. Non-smokers (no current or previous tobacco use). Participants who underwent optical coherence tomography (OCT) imaging. Participants who provided written informed consent and agreed to participate in the study.
Key exclusion criteria (2 listed)
- Presence of any systemic disease. Current or former smokers. Participants with incomplete clinical or OCT data. Individuals who did not provide written informed consent.
- -
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
Correlation Between Periodontal Disease Severity and Choroidal Thickness
Time frame: Baseline
The correlation between periodontal disease severity and choroidal thickness will be assessed using Spearman's correlation coefficient (rₛ). Periodontal disease severity will be assessed using probing pocket depth (PPD) and clinical attachment level (CAL), measured in millimeters (mm) using a periodontal probe. Choroidal thickness will be measured in micrometers (µm) using spectral-domain optical coherence tomography (SD-OCT).
3 secondary outcomes
Correlation Between Periodontal Disease Severity and Retinal Nerve Fiber Layer (RNFL) Thickness
Time frame: Baseline
Correlation Between Periodontal Disease Severity and Ganglion Cell Layer (GCL) Thickness
Time frame: Baseline
Correlation Between Periodontal Disease Severity and Inner Plexiform Layer (IPL) Thickness
Time frame: 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 5 Oct 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared to protect participant confidentiality and privacy.
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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.
Metin Çalışır, Prof.DR contact
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 Periodontal Diseases and Periodontal Diseases Inflammation, run by Zeliha Başak Çakır Erdil at 1 site in Turkey (Türkiye).
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 1 inclusion and 2 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: opening soon, as of the sponsor's last update on 5 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 Turkey (Türkiye). 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 Zeliha B ÇAKIR ERDİL, DDS (+905059444038, bskcakirr@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation Between Periodontal Disease Severity and Choroidal Thickness (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Oct 2026.