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NCT06235021
Clinical Efficacy of Saffron Mouth Rinse in Periodontitis Patients With Renal Disease
NA trial testing Saffron in Periodontal Diseases in 20 participants. Status unknown.
12 January 2024
Quick facts
| Lead sponsor | British University In Egypt |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 20 |
| Start date | 1 January 2024 |
| Primary completion | 12 January 2024 |
| Estimated completion | 1 March 2024 |
| Sites | 1 location across Egypt |
Drugs / interventions tested
- Saffron
- chlorhexidine mouthwash — full drug profile →
Conditions studied
- Periodontal Diseases — all drugs for Periodontal Diseases →
- Periodontal Pocket — all drugs for Periodontal Pocket →
- Periodontal Inflammation — all drugs for Periodontal Inflammation →
Sponsor
British University In Egypt
Who can join
19 and older, any sex, with Periodontal Diseases or Periodontal Pocket. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The commensal oral bacteria are responsible for the initiation and propagation of the disease through the process of dysbiosis, or microbial imbalance. The disease proceeds cyclically with periods of activity and quiescence until therapeutic action is taken, or the tooth and surrounding structures are destroyed by the disease process that may result in the loss of the tooth. As periodontal disease progresses from gingivitis to periodontitis, a greater number of anaerobic organisms colonize deeper periodontal pockets, such as Aggregatibacter actinomycetemcomitans and Porphyromonas gingivalis, which triggers the host inflammatory response. This response includes the production and dissemination of C-reactive protein (CRP), a biomarker of inflammation, as well as various neutrophil and macrophage compounds such as tumor necrosis factor-alpha (TNF-a), matrix metalloproteinases (MMPs), and interleukins (IL-1 and IL-8). An elevated serum CRP level suggests that the inflammation arising as a result of periodontitis may correlate with cardiovascular pathology. Additionally, smoking creates an increasingly favorable environment for the growth of periodontal pathogens, thus furthering the disease process. In recent meta-analysis, published articles on the effect of saffron supplementation on three inflammatory biomarkers (CRP, TNF-α, and IL-6) were evaluated. Combining eight eligible trials, it was demonstrated that saffron supplementation did not have a significant effect on serum levels of the three inflammatory biomarkers. However, in the subgroup analysis, saffron was found to significantly reduce CRP and TNF-α serum concentrations
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06235021
- Europe PMC full search
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Related trials
Other trials of Saffron
Trials testing the same drug.
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- NCT04750681 — Evaluation of the Effects of Saffron Extract on Sleep Quality and Stress · NA · completed
Other recruiting trials for Periodontal Diseases
Currently open trials in the same condition.
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- NCT07312045 — HALP Score, Blood-Based Inflammatory Indices, and Salivary MMP-8 in Periodontal Disease and Healing After Non-Surgical T · recruiting
- NCT07384221 — Periodontal Status and Disease Severity in Pemphigus Vulgaris Patients · recruiting
- NCT07530978 — ORAL HYGIENE, PERIODONTAL STATUS AND QUALITY OF LIFE · recruiting
- NCT06848790 — Interdental Hygiene Methods in Young Adults · NA · recruiting
Other British University In Egypt trials
Trials by the same sponsor.
- NCT07492576 — Evaluation of the Magnesium Shield Compared to Dual Zone Grafting Approach in Immediate Implant Site Management · NA · recruiting
- NCT07457749 — Clinical Performance of a Novel Self-cured Resin Composite Compared to a Light-cured Bioactive Resin Composite Restorati · EARLY_PHASE1 · recruiting
- NCT07368621 — Effectiveness of Connective Tissue Graft With and Without Leukocyte Platelet Rich Fibrin on Peri-implant Soft Tissue Thi · NA · recruiting
- NCT07480070 — Two-Year Clinical Performance of Self-Cured Resin Composite in Comparison to Light-Cured Bioactive Resin Composite in Re · NA · completed
- NCT07115758 — Vestibular Versus Trapezoid Flap in Immediate Implants · NA · not yet recruiting
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 NCT06235021 (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 British University In Egypt
- Last refreshed: 31 January 2024
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