Gingival and Periodontal DiseaseEarly Phase 1NCT06908265

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.

A Early Phase 1 study testing Toothpaste including mustard extract in people with Gingival and Periodontal Disease and Caries, Dental, run by Medical University of Warsaw.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Gingival and Periodontal Disease, Caries, Dental
What is being tested?: Toothpaste including mustard extract
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 113 participants
Where: No sites listed yet
Study dates: Mar 2015to Jan 2017
Phase: Early Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

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.

About this study

Official title: 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.

Conditions: Gingival and Periodontal Disease, Caries, Dental
Being tested: Toothpaste including mustard extract, Placebo
Keywords: Caries., thioglycosides, periodontitis, gingivitis, lactobacillus, toothpaste, mustard
Medical subject headings: Periodontal Diseases, Dental Caries, Periodontitis, Gingivitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Toothpaste including mustard extractDrug
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.
PlaceboDrug
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.

Study groups in NCT06908265
Study group	Role	What they receive
Experimental Group	Experimental	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. Receives: Drug: Toothpaste including mustard extract
Control Group	Placebo comparator	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. Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: 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).
Measured: From start of intervention, 4 weeks to end of intervention and data collection.

Secondary outcomes (3)

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).
Measured: 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).
Measured: 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).
Measured: 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2015Jan 2017

First posted3 Apr 2025
Study startMar 2015
Primary completionAug 2016
Study completionJan 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (4)Papers the sponsor has linked to this study.
Other trials for Gingival and Periodontal DiseaseStudies of the same condition, open and under way.
More trials run by Medical University of WarsawThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Early Phase 1
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Model description: Participants were divided into two groups, experimental and control. The experimental group received an intervention - mustard toothpaste. The control group received a control toothpaste without mustard extract.
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 113 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06908265
Sponsor's protocol ID: KB/58/2011
Status last verified: Mar 2025
First submitted: 19 Mar 2025
Last updated: 3 Apr 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: We will share data including results and statistical analyses in publication after the complement od the study.

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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Enrolling by invitation
Comparison of the Effects of Oral Hygiene Regimens on Clinical, Immunomodulatory, and Microbial Outcomes and Oral Tolerance in People With Gingivitis
Microbiome, Cytokines
Active, not recruitingPhase 3
A Study to Assess the Efficacy of Two Brushing Regimens in the Reduction of Established Dental Plaque and Gingivitis
Plaque, Gingivitis
Not yet recruitingPhase 2
Efficacy of Thymus Vulgaris Mouthwash in the Management of Biofilm-Induced Gingivitis
Plaque-Induced Gingivitis
Not yet recruitingPhase 3
Periodontal Disease and Small Vulnerable Newborns in Rural Nepal: A Community-based Trial
Preterm Birth, Low Birth Weight
Not yet recruiting
Spirulina Gel in the Treatment of Periodontitis
Periodontitis, Periodontitis Stage II

All Gingival and Periodontal Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Evaluation of the Antibacterial Activity of Thioglycosides Extracted from White Mustard - Bamberka in Oral Hygiene.
ClinicalTrials.gov ID: NCT06908265
Acronym / sponsor ID: KB/58/2011
Conditions: Gingival and Periodontal Disease, Caries, Dental
Keywords: Caries., thioglycosides, periodontitis, gingivitis, lactobacillus, toothpaste, mustard
Phase: Early Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 113 participants (actual)
Lead sponsor: Medical University of WarsawUniversity, hospital or other
Study start: Mar 2015 (actual)
Primary completion: Aug 2016 (actual)
Study completion: Jan 2017 (actual)
First posted: 3 Apr 2025 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Brief Summary

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 design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2
Model description: Participants were divided into two groups, experimental and control. The experimental group received an intervention - mustard toothpaste. The control group received a control toothpaste without mustard extract.

Arm	Type	Receives
Experimental Group	Experimental	Drug: Toothpaste including mustard extractParticipants 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 comparator	Drug: PlaceboParticipants 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.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

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,

Key exclusion criteria (7 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Toothpaste including mustard extractIntervention: 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	Experimental Group
Placebolacebo 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.	Drug	Control Group

Primary outcome

Change in Plaque Index (PI) from Baseline (T0) to Week 4 (T1)
Time frame: 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)
Time frame: 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).

3 secondary outcomes

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

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2025.
Background: PubMed 20936314Arweiler 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.
Background: PubMed 31430999Melrose 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.
Background: PubMed 23575118David 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.
Background: PubMed 32448381Eichel 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.
Individual participant dataSharing planned: Yes. We will share data including results and statistical analyses in publication after the complement od the study.

Related trials for Gingival and Periodontal Disease

Enrolling by invitation
Comparison of the Effects of Oral Hygiene Regimens on Clinical, Immunomodulatory, and Microbial Outcomes and Oral Tolerance in People With Gingivitis
Microbiome, Cytokines
Active, not recruitingPhase 3
A Study to Assess the Efficacy of Two Brushing Regimens in the Reduction of Established Dental Plaque and Gingivitis
Plaque, Gingivitis
Not yet recruitingPhase 2
Efficacy of Thymus Vulgaris Mouthwash in the Management of Biofilm-Induced Gingivitis
Plaque-Induced Gingivitis
Not yet recruitingPhase 3
Periodontal Disease and Small Vulnerable Newborns in Rural Nepal: A Community-based Trial
Preterm Birth, Low Birth Weight
Not yet recruiting
Spirulina Gel in the Treatment of Periodontitis
Periodontitis, Periodontitis Stage II

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Toothpaste including mustard extract in people with Gingival and Periodontal Disease and Caries, Dental, run by Medical University of Warsaw.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Plaque Index (PI) from Baseline (T0) to Week 4 (T1) (time frame: From start of intervention, 4 weeks to end of intervention and data collection.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06908265, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2025.