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.

Early Phase 1

Completed

• Conditions: Gingival and Periodontal Disease; Caries, Dental
• Interventions: Drug: Toothpaste including mustard extract; Drug: Placebo

• Registration Number: NCT06908265
• Lead Sponsor: Medical University of Warsaw

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-03
• Primary Completion: 2016-08
• Study Completion: 2017-01
• Status Verified: 2025-03
• Study First Submitted: 2025-03-19
• Study First Submitted QC: 2025-03-26
• Last Update Submitted: 2025-03-26
• Study First Posted: 2025-04-03
• Last Update Posted: 2025-04-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 113

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental Group	Toothpaste including mustard extract	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.
Control Group	Placebo	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.

Primary Outcome Measures

Name	Time	Method
Change in Plaque Index (PI) from Baseline (T0) to Week 4 (T1)	From start of intervention, 4 weeks to end of intervention and data collection.	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).
Change in Bleeding on Probing (BoP) from Baseline (T0) to 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) 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).

Secondary Outcome Measures

Name	Time	Method
Change in Approximal Plaque Index (API) from Baseline (T0) to Week 4 (T1)	4 weeks	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).
Change in Gingival Index (GI) from Baseline (T0) to Week 4 (T1)	4 weeks	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).
Change in Salivary Bacterial Loads of Streptococcus mutans and Lactobacillus spp. from Baseline (T0) to Week 4 (T1)	4 weeks	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).