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CompletedNCT06908265Updated Apr 3, 2025

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.

An Early Phase 1 interventional study of Toothpaste including mustard extract and Placebo in Gingival and Periodontal Disease and Caries, Dental, sponsored by Medical University of Warsaw. Completed. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-04-03.

Sponsored by Medical University of Warsaw · Early Phase 1, Interventional, and Prevention

From the registry’s dates

  • Registered 10 years after the study started (first participant enrolled Mar 2015, registered Mar 2025).
Phase
Early Phase 1
Study type
Interventional
Enrollment
113
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Gingival and Periodontal Disease
  • Caries, Dental

Keywords

  • Caries.
  • thioglycosides
  • periodontitis
  • gingivitis
  • lactobacillus
  • toothpaste
  • mustard
03

In context

Periodontal Diseases

855 studies on the registry are indexed under Periodontal Diseases; 189 are open to participants now.

This study's enrollment of 113 is above the median of 45 across 546 interventional studies indexed under Periodontal Diseases.

Browse Periodontal Diseases studies →

Lead sponsor

Medical University of Warsaw is the lead sponsor of 325 studies on the registry; 87 are open to participants now.

Browse Medical University of Warsaw studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Early Phase 1
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
113 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • DrugToothpaste 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.

  • DrugPlacebo

    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.

06

What researchers measure

Primary outcomes

  1. 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).

    Time frame: From start of intervention, 4 weeks to end of intervention and data collection.

  2. 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).

    Time frame: From start of intervention, 4 weeks to end of intervention and data collection.

Secondary outcomes

  1. 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).

    Time frame: 4 weeks

  2. 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).

    Time frame: 4 weeks

  3. 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).

    Time frame: 4 weeks

07

Study locations

No study locations are listed for this record.

08

References and documents

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. PubMed 20936314 ↗
  • 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. PubMed 31430999 ↗
  • 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. PubMed 23575118 ↗
  • 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. PubMed 32448381 ↗

Individual participant data

Plan to share: Yes — We will share data including results and statistical analyses in publication after the complement od the study.

Supporting information: Study protocol

Time frame: The publication will be available in open-access journal

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Mar 2015 to primary completion in Aug 2016, 17 months.

Of 13 phase 1 interventional studies under Periodontal Diseases, half reached primary completion within 10 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 17. This study's 17 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 19, 2025
First posted
Apr 3, 2025
StartActual
Mar 2015
Primary completionActual
Aug 2016
CompletionActual
Jan 2017
Last update
Apr 3, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 3, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06908265
Lead sponsor
Medical University of Warsaw
Responsible party
Sponsor
First posted
Apr 3, 2025
Start date
Mar 2015
Primary completion
Aug 2016
Completion
Jan 2017
Last update
Apr 3, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.

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