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

NCT06235021 | Unknown DMC

• 1 other identifier: 23-064
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Saffron; Renal; Periodontitis

Outcome Measures

Primary Outcomes (1)

• Clinical attachment loss (CAL)

  With a periodontal probe, pocket depth (PD) and clinical attachment loss (CAL) will be measured on six locations of the teeth (mesio-buccal/facial, mid-buccal/facial, disto-buccal/facial, mesio-lingual/palatinal, mid-lingual/palatinal, disto-lingual/palatinal).

  6 weeks

Secondary Outcomes (3)

• Bleeding on probing

  6 weeks

• Plaque index

  6 weeks

• Gingival crevicular fluid (C- reactive protein)

  6 weeks

Study Arms (2)

Saffron

EXPERIMENTAL

The experimental group will receive scaling and root debridement and will be instructed to use a mouthwash containing aqueous extract of saffron twice a day for 6 weeks.

Other: Saffron

chlorhexidine mouthwash.

PLACEBO COMPARATOR

The control group will receive scaling and root debridement and gargle their mouth with commercial product of 0.2% chlorhexidine mouthwash.

Other: chlorhexidine mouthwash

Interventions

Saffron OTHER

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).

Saffron

chlorhexidine mouthwash OTHER

commercial product of 0.2% chlorhexidine mouthwash.

chlorhexidine mouthwash.

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Both genders, aged above 18 years.
• All patients must have a periodontal disease.
• Patients must be able to make reliable decision or communications.

You may not qualify if:

• \- Smoking, Alcohol.
• Vulnerable groups such as pregnant females, prisoners, mentally and physically handicapped individuals.
• Known hypersensitivity or severe adverse effects to the treatment drugs or to any ingredient of their preparation.

Sponsors & Collaborators

• British University In Egypt: lead

Study Sites (1)

The British University in Egypt

Cairo, 3753450, Egypt

RECRUITING

MeSH Terms

Conditions

Periodontal Diseases; Periodontal Pocket; Periodontitis

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Study Officials

• Dalia Ghalwash

  The British University in Egypt

  STUDY DIRECTOR

Central Study Contacts

Asmaa Ras, Phd

CONTACT

01098015060; asmaa.aboubakr@bue.edu.eg

Dalia Ghalwash, Phd

CONTACT

01005120159; Dalia.ghalwash@bue.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The clinical outcome assessor (A.A) will not be aware of which treatment will be being administered, thus yielding a single-blind controlled study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: The experimental group will receive scaling and root debridement and will be instructed to use a mouthwash containing aqueous extract of saffron twice a day for 6 weeks.

Study Record Dates

• First Submitted: January 2, 2024
• First Posted: January 31, 2024
• Study Start: January 1, 2024
• Primary Completion: January 12, 2024
• Study Completion: March 1, 2024
• Last Updated: January 31, 2024

Record last verified: 2024-01

Locations

EG (1)