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

NCT06638580 | Completed

• 1 other identifier: 2022/157
• Study Type: observational
• Target: 92
• Locations: 1 country
• Sites: 1

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.

Conditions

Periodontitis; Metabolic Syndrome; Neurodegeneration; Oxidative Stress; Optic Coherence Tomography

Keywords

periodontitis; metabolic syndrome; neurodegeneration; oxidative stress; optic coherence tomography

Outcome Measures

Primary Outcomes (1)

• optical coherence tomography (OCT)

  Retinal and choroidal imaging and measurements will perform with it.

  6 months

Secondary Outcomes (2)

• probing pocket depth (PPD)

  6 months

• clinical attachment level (CAL)

  6 months

Study Arms (4)

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

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

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

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

Interventions

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.

Control; MetS; PD; PD-MetS

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Rize, Türkiye

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Recep Tayyip Erdogan University: lead

Study Sites (1)

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

Rize, 53200, Turkey (Türkiye)

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum

MeSH Terms

Conditions

Periodontitis; Metabolic Syndrome; Nerve Degeneration

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: October 8, 2024
• First Posted: October 15, 2024
• Study Start: May 1, 2022
• Primary Completion: July 30, 2022
• Study Completion: October 30, 2022
• Last Updated: October 15, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)