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.

Study Overview

• Status: Completed
• Conditions: Periodontitis; Metabolic Syndrome; Oxidative Stress; Neurodegeneration; Optic Coherence Tomography
• Intervention / Treatment: Diagnostic test: 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

• Study Type: Observational
• Enrollment (Actual): 92

Contacts and Locations

Study Locations

• Turkey
  • Rize, Turkey, 53200
    • Department of Ophthalmology of the Faculty of Medicine of Recep Tayyip Erdogan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Rize, Türkiye

Description

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 Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Control; Systemically and periodontally healthy	Diagnostic test: 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; 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.
PD; systemically healthy periodontitis	Diagnostic test: 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; 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.
MetS; periodontally healthy metabolic syndrome	Diagnostic test: 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; 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.
PD-MetS; periodontitis and metabolic syndrome combined	Diagnostic test: 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
optical coherence tomography (OCT)	Retinal and choroidal imaging and measurements will perform with it.	6 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Recep Tayyip Erdogan University

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2022
• Primary Completion (Actual): July 30, 2022
• Study Completion (Actual): October 30, 2022

Study Registration Dates

• First Submitted: October 8, 2024
• First Submitted That Met QC Criteria: October 10, 2024
• First Posted (Actual): October 15, 2024

Study Record Updates

• Last Update Posted (Actual): October 15, 2024
• Last Update Submitted That Met QC Criteria: October 10, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: neurodegeneration; periodontitis; oxidative stress; metabolic syndrome; optic coherence tomography
• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Disease; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Insulin Resistance; Hyperinsulinism; Syndrome; Periodontitis; Metabolic Syndrome; Nerve Degeneration
• Other Study ID Numbers: 2022/157

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual data may be shared if requested with reasonable justification.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No