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.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

113 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-31

Study Completion Date

2017-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Gingival and Periodontal Disease Caries, Dental

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Participants were randomly assigned to two groups and blinded - Experimental vs placebo. They got toothpaste samples in identically marked white tubes.

Study Groups

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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.

Group Type EXPERIMENTAL

Toothpaste including mustard extract

Intervention Type DRUG

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.

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.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type 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.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes