Trials / Completed
CompletedNCT06638580
Periodontitis Provokes Retinal Neurodegenerative Effects of Metabolic Syndrome: A Cross-Sectional Study
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 92 (actual)
- Sponsor
- Recep Tayyip Erdogan University · Academic / Other
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2022-05-01
- Primary completion
- 2022-07-30
- Completion
- 2022-10-30
- First posted
- 2024-10-15
- Last updated
- 2024-10-15
Locations
1 site across 1 country: Turkey (Türkiye)
Source: ClinicalTrials.gov record NCT06638580. Inclusion in this directory is not an endorsement.