Clinical Efficacy of Saffron Mouth Rinse in Periodontitis Patients With Renal Disease

Summary

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

Conditions

• Periodontal Diseases
• Periodontal Pocket
• Periodontal Inflammation

Interventions

OTHER

Saffron

Saffron powder (purchased from Moayeri Copmany2 in Oman, prepared from the stigma of Crocus sativus L.). Total of 10 mg of saffron powder will be added to 100 ml of distilled water. Then, it will be incubated on a shaker for 24 h. The material will be passed through several layers of muslin cloth. The extracts will then be poured into a round bottom balloon and placed in the freezer at a temperature of -80°C. After freezing, the extracts were placed in a freeze-dryer. In vacuum, the solvent will be removed and saffron powder will be obtained. After preparing the initial concentration, serial dilution with ratios of one-half and one-third will be performed in sterile vials and one-half of the final concentration will be discarded. After the preparation of extract, the 0.2% saffron mouthwash will be prepared by mixing the following ingredients: 1. propylene glycol (5 g) 2. saffron extract (0.2 g) 3. polysorbate 80 (1.8 g) 4. sodium benzoate (0.2 g) 5. water (91 g).

OTHER

chlorhexidine mouthwash

commercial product of 0.2% chlorhexidine mouthwash.

Sponsors & Collaborators

• British University In Egypt

  lead OTHER

Principal Investigators

• Dalia Ghalwash · The British University in Egypt

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

19 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-01-01

Primary Completion

2024-01-12

Completion

2024-03-01

Countries

• Egypt

Study Locations