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.

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.

Study Overview

• Status: Completed
• Conditions: Caries, Dental; Gingival and Periodontal Disease
• Intervention / Treatment: Drug: Toothpaste including mustard extract; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 113
• Phase: Early Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• age between 18 and 65 years,
• the presence of at least 20 teeth excluding third molars,
• a diagnosis of gingivitis according to the 2017 World Workshop
• non-smokers.
• the motivation to take part in the study,
• proper oral home hygiene
• sign a consent agreement for the participation in the study

Exclusion Criteria:

• patients aged <18
• the presence of less than 20 teeth
• severe systemic diseases and diseases that require regular systemic drugs (diabetes mellitus)
• the use of systemic antibiotics during the last 3 months or local antiseptics that may affect biofilm formation (antibacterial mouth rinses containing chlorhexidine 4 weeks or less prior recruitment)
• allergy to mustard or any other compound of experimental toothpaste
• patients undergoing orthodontic treatment
• women who were pregnant or breastfeeding.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental Group; Participants in this group receive a herbal toothpaste containing white mustard (Sinapis alba) extract. The toothpaste is formulated with 0.5% white mustard extract, known for its antibacterial properties. Participants are instructed to brush their teeth twice daily for 4 weeks using this toothpaste. The primary goal is to evaluate its effect on plaque index (PI), approximal plaque index (API), gingival index (GI), bleeding on probing (BoP), and the bacterial loads of Streptococcus mutans and Lactobacillus spp.	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.
Placebo Comparator: Control Group; Participants in this group receive a placebo toothpaste, which has the same base formulation as the experimental toothpaste but without white mustard extract. They are also instructed to brush their teeth twice daily for 4 weeks using the assigned toothpaste. This arm serves as a control group to compare the effects of the herbal toothpaste with a non-herbal alternative.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Plaque Index (PI) from Baseline (T0) to Week 4 (T1)	Change in Plaque Index (PI) from Baseline (T0) to Week 4 (T1) Measured using the Silness and Loe Plaque Index (PI) Scale to assess plaque accumulation on tooth surfaces. Unit: Plaque score (0-3 scale). Time Frame: Baseline (T0) and Week 4 (T1).	From start of intervention, 4 weeks to end of intervention and data collection.
Change in Bleeding on Probing (BoP) from Baseline (T0) to Week 4 (T1)	Change in Bleeding on Probing (BoP) from Baseline (T0) to Week 4 (T1) Measured using the Ainamo and Bay method, which evaluates gingival bleeding after gentle probing. Unit: Percentage of bleeding sites. Time Frame: Baseline (T0) and Week 4 (T1).	From start of intervention, 4 weeks to end of intervention and data collection.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Approximal Plaque Index (API) from Baseline (T0) to Week 4 (T1)	Measured based on the presence of plaque in interdental areas. Unit: Percentage of interdental sites with plaque. Time Frame: Baseline (T0) and Week 4 (T1).	4 weeks
Change in Gingival Index (GI) from Baseline (T0) to Week 4 (T1)	Measured using the Loe and Silness Gingival Index (GI) Scale to assess the degree of gingival inflammation. Unit: Gingival index score (0-3 scale). Time Frame: Baseline (T0) and Week 4 (T1).	4 weeks
Change in Salivary Bacterial Loads of Streptococcus mutans and Lactobacillus spp. from Baseline (T0) to Week 4 (T1)	Measured using the Caries Risk Test (CRT, Ivoclar Vivadent) to determine bacterial colony counts in saliva samples. Unit: Colony-forming units per milliliter (CFU/ml). Time Frame: Baseline (T0) and Week 4 (T1).	4 weeks

Collaborators and Investigators

• Sponsor: Medical University of Warsaw

Publications and helpful links

General Publications

• Arweiler NB, Pergola G, Kuenz J, Hellwig E, Sculean A, Auschill TM. Clinical and antibacterial effect of an anti-inflammatory toothpaste formulation with Scutellaria baicalensis extract on experimental gingivitis. Clin Oral Investig. 2011 Dec;15(6):909-13. doi: 10.1007/s00784-010-0471-1. Epub 2010 Oct 9.
• Melrose J. The Glucosinolates: A Sulphur Glucoside Family of Mustard Anti-Tumour and Antimicrobial Phytochemicals of Potential Therapeutic Application. Biomedicines. 2019 Aug 19;7(3):62. doi: 10.3390/biomedicines7030062.
• David JR, Ekanayake A, Singh I, Farina B, Meyer M. Effect of white mustard essential oil on inoculated Salmonella sp. in a sauce with particulates. J Food Prot. 2013 Apr;76(4):580-7. doi: 10.4315/0362-028X.JFP-12-375.
• Eichel V, Schuller A, Biehler K, Al-Ahmad A, Frank U. Antimicrobial effects of mustard oil-containing plants against oral pathogens: an in vitro study. BMC Complement Med Ther. 2020 May 24;20(1):156. doi: 10.1186/s12906-020-02953-0.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2015
• Primary Completion (Actual): August 1, 2016
• Study Completion (Actual): January 1, 2017

Study Registration Dates

• First Submitted: March 19, 2025
• First Submitted That Met QC Criteria: March 26, 2025
• First Posted (Actual): April 3, 2025

Study Record Updates

• Last Update Posted (Actual): April 3, 2025
• Last Update Submitted That Met QC Criteria: March 26, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: periodontitis; gingivitis; lactobacillus; toothpaste; mustard; Caries.; thioglycosides
• Additional Relevant MeSH Terms: Mouth Diseases; Stomatognathic Diseases; Tooth Diseases; Tooth Demineralization; Periodontal Diseases; Dental Caries; Antineoplastic Agents; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents, Alkylating; Alkylating Agents; Mechlorethamine
• Other Study ID Numbers: KB/58/2011

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: We will share data including results and statistical analyses in publication after the complement od the study.
• IPD Sharing Time Frame: The publication will be available in open-access journal
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No