Clinical trial 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.
Official title: Clinical Evaluation of the Antibacterial Activity of Thioglycosides Extracted from White Mustard - Bamberka in Oral Hygiene.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Gingival and Periodontal Disease
Caries, Dental
Keywords: Caries.
thioglycosides
periodontitis
gingivitis
lactobacillus
toothpaste
mustard
Lead sponsor: Medical University of Warsaw
Sponsor class: OTHER
First posted: 2025-04-03
Enrollment: 113
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: PREVENTION

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in Plaque Index (PI) from Baseline (T0) to Week 4 (T1)
timeFrame: From start of intervention, 4 weeks to end of intervention and data collection.
measure: Change in Bleeding on Probing (BoP) from Baseline (T0) to Week 4 (T1)
timeFrame: From start of intervention, 4 weeks to end of intervention and data collection.
Secondary outcomes:
measure: Change in Approximal Plaque Index (API) from Baseline (T0) to Week 4 (T1)
timeFrame: 4 weeks
measure: Change in Gingival Index (GI) from Baseline (T0) to Week 4 (T1)
timeFrame: 4 weeks
measure: Change in Salivary Bacterial Loads of Streptococcus mutans and Lactobacillus spp. from Baseline (T0) to Week 4 (T1)
timeFrame: 4 weeks
Other outcomes:
Locations:
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.