Periodontitis Provokes Retinal Neurodegenerative Effects of Metabolic Syndrome: A Cross-Sectional Study

This cross-sectional study aimed to investigate the retino-choroidal degenerative effects of periodontitis, metabolic syndrome (Mets), and the combination of these diseases using optical coherence tomography (OCT) measurements. Methods: Ninety-two patients selected according to inclusion criteria were divided into 4 groups: systemically and periodontally healthy (Control), systemically healthy periodontitis (PD), periodontally healthy metabolic syndrome (MetS), and periodontitis and metabolic syndrome combined (PD-MetS). The systemic inflammatory-oxidative effects of periodontitis and MetS were biochemically evaluated using serum TNF (Tumor necrosis factor)-α level, IL(Interleukin)-1β/IL-10 ratio, and oxidative stress index (OSI: TOS/TAS). Retinal (AMT, peripapillary retinal nerve fiber layer thickness (pRNFLT), and Ganglion cell and Inner plexiform layers (GCL+T) and choroidal (SFCT) morphometric measurements and vascular evaluations (foveal capillary density) were performed via OCT Angio with swept-source technology.

To the best of our knowledge, although there are many clinical studies on the possible effects of Mets on retino-choroidal layers, there is a limited amount of evidence on the effects of periodontitis which is from an animal study. Moreover, there are no studies on the retinal degenerative effects of the combined presence of periodontitis and Mets. In this context, the present study is unique and based on the hypothesis that the alone or combined presence of periodontitis and Mets may provoke retino-choroidal degenerative changes through systemic inflammatory stress.

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Key information

Conditions

Periodontitis Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Metabolic Syndrome Mouth Diseases Nerve Degeneration Neurodegeneration Nutritional and Metabolic Diseases Optic Coherence Tomography Oxidative Stress Pathologic Processes Pathological Conditions, Signs and Symptoms Periodontal Diseases Stomatognathic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Rize, 53200, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Individuals with stage III/IV, grade C periodontitis,
Patients with at least 20 teeth,
Patients diagnosed with MetS,
Obese [waist circumference (WC) 80 cm ≥ for women and 94 cm ≥ for men], Type 2 (Diabetes Mellitus) DM and hypertensive patients.

Exclusion criteria

Cancer,
Any autoimmune disease,
Osteoporosis,
Active infectious disease (acute hepatitis, tuberculosis, AIDS),
Vitreoretinal, optic nerve or choroidal vascular disease,
Acute and chronic ocular diseases (such as cataract, glaucoma, macular degeneration, uveitis, Behçet's, scleritis),
History of refractive or intraocular surgery,
Immunosuppressive, oral contraceptive, bisphosphonate and antioxidant drug use,
Pregnancylactation,
Smokers.

Treatment and study plan

Clinical Periodontal Measurements (plaque index, gingival index, bleeding index, clinical attachment level), Optical Coherence Tomographic Measurements, Serum IL1-β, TNF-α, IL-10, TAS, TOS, OSİ levels

Diagnostic Test

Probing pocket depth (PPD) was measured as the distance between the deepest point of the sulcus (or pocket) and the gingival margin, and clinical attachment level (CAL) was measured as the distance between the base of the pocket and the cementoenamel junction. PPD and CAL were measured at six different points (mesio-buccal, mid-buccal, disto-buccal, mesio-lingual, mid-lingual, and disto-lingual) in each tooth, and other index scores were taken at four different points (mesial, distal, vestibular and palatinal).

Serum IL1-β, TNF-α, and IL-10 levels were measured via immunosorbent assay method using human-specific kits according to the kit manufacturer's instructions.

Serum total antioxidant status (TAS) and total oxidant status (TOS) levels were mea-sured by a spectrophotometric method using specific kits.

Retinal and choroidal imaging and measurements were performed with optical coherence tomography (SS-OCT) with swept-source (SS) technology and non-invasive OCT angiography.

Primary outcomes

optical coherence tomography (OCT)

Time frame: 6 months

Retinal and choroidal imaging and measurements will perform with it.

Secondary outcomes

probing pocket depth (PPD)

Time frame: 6 months

It measures as the distance between the deepest point of the sulcus (or pocket) and the gingival margin
clinical attachment level (CAL)

Time frame: 6 months

CAL will measure as the distance between the base of the pocket and the cemento-enamel junction.

Sponsors and collaborators

Lead sponsor

Recep Tayyip Erdogan University

Other

Registry information

Important dates

Study start: 2022
Primary completion: 2022
Study completion: 2022
First posted: Oct 15, 2024
Registry last updated: Oct 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed