Periodontitis Severity in Patients With Diabetic Retinopathy

NCT ID: NCT07137013

Last Updated: 2025-08-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-02-24

Study Completion Date

2025-06-23

Brief Summary

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The aim of this observational study is to investigate the relationship between periodontal disease severity and retinal layer thickness in patients diagnosed with diabetic retinopathy (DR), using optical coherence tomography (OCT) for assessment.

The main question this study seeks to answer is:

Do measurable changes in retinal layer thickness occur as periodontal disease severity increases in patients with diabetic retinopathy?

Participants will include adult individuals with a confirmed clinical diagnosis of DR. Periodontal status will be assessed through standard clinical parameters, including plaque index, probing pocket depth, clinical attachment loss, and bleeding on probing. Retinal layer thickness will be measured using high-resolution OCT and OCT angiography (OCTA) devices. The study aims to analyze potential associations between periodontal disease severity and morphological as well as vascular changes in the retina.

Detailed Description

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This observational study will aim to evaluate the possible relationship between periodontal disease severity and retinal layer thickness in patients with diabetic retinopathy (DR). Adult individuals with a confirmed clinical diagnosis of DR will be included in the study. Periodontal health status will be assessed using standard clinical parameters such as plaque index, probing pocket depth, clinical attachment loss, and bleeding on probing. Retinal layer thickness will be measured using high-resolution imaging with optical coherence tomography (OCT). Optical coherence tomography angiography (OCTA) will be used to evaluate vascular changes. The collected data will be analyzed to determine whether periodontal disease severity is associated with possible changes in retinal morphology and vascularity. This study is expected to provide new scientific evidence on the interaction between systemic diabetic complications and oral health, as well as to highlight the importance of multidisciplinary approaches.

Conditions

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Diabetic Retinopathy Periodontitis

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Control

without systemic disease

No interventions assigned to this group

DM+ DR-

Diagnosed with Diabetes Mellitus and not diagnosed with Diabetic Retinopathy

No interventions assigned to this group

NPDR+ DMÖ-

Diagnosed with non-proliferative Diabetic Retinopathy without diabetic macular edema

No interventions assigned to this group

NPDR+ DMÖ+

Diagnosed with non-proliferative DR with diabetic macular edema

No interventions assigned to this group

PDR

Diagnosed with proliferative Diabetic Retinopathy

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Men and women aged 60 and over
* Those without systemic disease (control group)
* Patients diagnosed with diabetic retinopathy
* Patients diagnosed with diabetes mellitus (HbA1c\>6)

Exclusion Criteria

* Patients with any autoimmune disease, osteoporosis, or cancer
* Patients taking immunosuppressive medications, oral contraceptives, or bisphosphonates
* Pregnancy
* Patients with acute or chronic eye diseases such as vitreoretinal, optic nerve, or choroidal vascular diseases, cataracts, glaucoma, retinal degeneration, uveitis, Behçet's disease, or scleritis
* Patients undergoing refractive or intraocular surgery
* Presence of active infectious disease (acute hepatitis, tuberculosis, AIDS)
* Chronic use of medications affecting periodontal tissues (cyclosporine A, phenytoin)
* Patients taking antioxidant supplements
Minimum Eligible Age

60 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Recep Tayyip Erdogan University Training and Research Hospital

OTHER

Sponsor Role lead

Responsible Party

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Dilek KARADOĞAN

Assoc. Prof. Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Department of Ophthalmology of the Faculty of Medicine of Recep Tayyip Erdogan University

Rize, Rize Province, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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DR2025/59

Identifier Type: -

Identifier Source: org_study_id

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