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 1CompletedNCT06908265

Medical University of Warsaw113 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

113

Conditions

Gingival and Periodontal Disease Caries, Dental

Interventions

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

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

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

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

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