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NCT06638580
Periodontitis Provokes Retinal Neurodegenerative Effects of Metabolic Syndrome: A Cross-Sectional Study
trial testing 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 in Periodontitis in 92 participants. Completed in 30 October 2022.
30 July 2022
Quick facts
| Lead sponsor | Recep Tayyip Erdogan University |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 92 |
| Start date | 1 May 2022 |
| Primary completion | 30 July 2022 |
| Estimated completion | 30 October 2022 |
| Sites | 1 location across Turkey (Türkiye) |
Drugs / interventions tested
- 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
Conditions studied
- Periodontitis — all drugs for Periodontitis →
- Metabolic Syndrome — all drugs for Metabolic Syndrome →
- Neurodegeneration — all drugs for Neurodegeneration →
- Oxidative Stress — all drugs for Oxidative Stress →
Sponsor
Recep Tayyip Erdogan University
Who can join
Adults 18 to 65, any sex, with Periodontitis or Metabolic Syndrome. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT06638580
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06638580 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Recep Tayyip Erdogan University
- Last refreshed: 15 October 2024
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