Clinical trial NCT06638580: Periodontitis Provokes Retinal Neurodegenerative Effects of Metabolic Syndrome: A Cross-Sectional Study
Official title: Periodontitis Provokes Retinal Neurodegenerative Effects of Metabolic Syndrome: A Cross-Sectional Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Periodontitis
Metabolic Syndrome
Neurodegeneration
Oxidative Stress
Optic Coherence Tomography
Keywords: periodontitis
metabolic syndrome
neurodegeneration
oxidative stress
optic coherence tomography
Lead sponsor: Recep Tayyip Erdogan University
Sponsor class: OTHER
First posted: 2024-10-15
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Rize, Türkiye

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.


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.

Primary outcomes:
measure: optical coherence tomography (OCT)
timeFrame: 6 months
Secondary outcomes:
measure: probing pocket depth (PPD)
timeFrame: 6 months
measure: clinical attachment level (CAL)
timeFrame: 6 months
Other outcomes:
Locations:
city: Rize
country: Turkey
facility: Department of Ophthalmology of the Faculty of Medicine of Recep Tayyip Erdogan University
Study officials:
References: