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

NCT ID: NCT06638580

Last Updated: 2024-10-15

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 92 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-05-01
• Study Completion Date: 2022-10-30

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

Study Design

• Observational Model Type: ECOLOGIC_OR_COMMUNITY
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Control

Systemically and periodontally healthy

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

Intervention Type: 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.

PD

systemically healthy periodontitis

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

Intervention Type: 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.

MetS

periodontally healthy metabolic syndrome

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

Intervention Type: 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.

PD-MetS

periodontitis and metabolic syndrome combined

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

Intervention Type: 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.

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

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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Recep Tayyip Erdogan University

OTHER

Sponsor Role: lead

Responsible Party

Hatice Yemenoglu

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

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

Rize, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

2022/157

Identifier Type: -

Identifier Source: org_study_id