NCT06908265

Clinical Evaluation of the Antibacterial Activity of Thioglycosides Extracted from White Mustard - Bamberka in Oral Hygiene. Evaluation of Periodontal Parameters and Oral Microbiota in Patients.

Clinical Evaluation of the Antibacterial Activity of Thioglycosides Extracted from White Mustard - Bamberka in Oral Hygiene.

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 113 (actual)
• Sponsor: Medical University of Warsaw · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

Brief Summary The goal of this randomized clinical trial is to evaluate the clinical and antibacterial effects of a herbal toothpaste containing white mustard (Sinapis alba) extract in patients diagnosed with gingivitis. The main questions it aims to answer are: Does the herbal toothpaste significantly reduce plaque index (PI), approximal plaque index (API), gingival index (GI), and bleeding on probing (BoP) compared to a placebo toothpaste? Does the herbal toothpaste effectively reduce the bacterial loads of Streptococcus mutans and Lactobacillus spp. in saliva compared to a placebo? Researchers will compare the effects of the herbal toothpaste to a placebo toothpaste to determine its efficacy in improving periodontal parameters and reducing bacterial levels. Participants will: Be randomly assigned to one of two groups: test group (herbal toothpaste) or control group (placebo toothpaste). Use the assigned toothpaste twice daily for 4 weeks. Undergo clinical evaluations at baseline (T0) and after 4 weeks (T1), including measurements of PI, API, GI, and BoP. Provide saliva samples at T0 and T1 for microbiological analysis of Streptococcus mutans and Lactobacillus spp. bacterial loads.

Conditions

• Gingival and Periodontal Disease
• Caries, Dental

Interventions

Type	Name	Description
DRUG	Toothpaste including mustard extract	Intervention: Herbal toothpaste containing 0.5% white mustard (Sinapis alba) extract. To assess its effect on plaque index (PI), approximal plaque index (API), gingival index (GI), bleeding on probing (BoP), and bacterial loads of Streptococcus mutans and Lactobacillus spp. Dosage and Usage: Participants brush their teeth twice daily for 4 weeks with the assigned toothpaste.
DRUG	Placebo	lacebo toothpaste, formulated identically to the experimental toothpaste but without white mustard extract. Serves as a control to compare the antibacterial and clinical effects of the herbal toothpaste. Dosage and Usage: Participants brush their teeth twice daily for 4 weeks with the placebo toothpaste.

Timeline

• Start date: 2015-03-01
• Primary completion: 2016-08-01
• Completion: 2017-01-01
• First posted: 2025-04-03
• Last updated: 2025-04-03