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Periodontitis Severity in Patients With Diabetic Retinopathy

R

Recep Tayyip Erdogan University Training and Research Hospital

Status

Completed

Conditions

Periodontitis
Diabetic Retinopathy

Study type

Observational

Funder types

Other

Identifiers

NCT07137013
DR2025/59

Details and patient eligibility

About

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.

Full description

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.

Enrollment

100 patients

Sex

All

Ages

60 to 85 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

100 participants in 5 patient groups

Control
Description:
without systemic disease
DM+ DR-
Description:
Diagnosed with Diabetes Mellitus and not diagnosed with Diabetic Retinopathy
NPDR+ DMÖ-
Description:
Diagnosed with non-proliferative Diabetic Retinopathy without diabetic macular edema
NPDR+ DMÖ+
Description:
Diagnosed with non-proliferative DR with diabetic macular edema
PDR
Description:
Diagnosed with proliferative Diabetic Retinopathy

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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