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

Completed

• Conditions: Periodontitis; Metabolic Syndrome; Neurodegeneration; Oxidative Stress; Optic Coherence Tomography

• Registration Number: NCT06638580
• Lead Sponsor: Recep Tayyip Erdogan University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-05-01
• Primary Completion: 2022-07-30
• Study Completion: 2022-10-30
• Status Verified: 2024-10
• Study First Submitted: 2024-10-08
• Study First Submitted QC: 2024-10-10
• Last Update Submitted: 2024-10-10
• Study First Posted: 2024-10-11
• Last Update Posted: 2024-10-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 92

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
optical coherence tomography (OCT)	6 months	Retinal and choroidal imaging and measurements will perform with it.

Secondary Outcome Measures

Name	Time	Method
probing pocket depth (PPD)	6 months	It measures as the distance between the deepest point of the sulcus (or pocket) and the gingival margin
clinical attachment level (CAL)	6 months	CAL will measure as the distance between the base of the pocket and the cemento-enamel junction.

Trial Locations

Locations (1)

Department of Ophthalmology of the Faculty of Medicine of Recep Tayyip Erdogan University; 🇹🇷 Rize, Turkey