- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07365748
Evaluation of Bacterial Contamination and Antimicrobial Efficacy on Charcoal-Infused vs, Standard Nylon Toothbrush Bristles.
This study compares two types of toothbrushes to see which one stays cleaner after use. Researchers want to know if toothbrushes with charcoal-infused bristles have fewer bacteria than standard toothbrushes with nylon bristles.
Participants in this study are adults and children who do not have gum disease or other major health issues. Everyone in the study will be assigned one of two types of toothbrushes:
- An eco-friendly toothbrush with charcoal bristles.
- A standard toothbrush with nylon bristles. Participants will use their assigned toothbrush at home for two specific time periods (one day and one week). They will follow simple instructions on how to brush and store the toothbrush. After each time period, they will return the toothbrush to the researchers.
The research team will test the bristles in a lab to count the bacteria. They will also measure how well the charcoal bristles stop bacteria from growing compared to the nylon bristles. This will help determine if charcoal toothbrushes are a more sanitary and eco-friendly option for daily oral care.
Study Overview
Status
Detailed Description
Study Design and Randomization This study employs a randomized, parallel-group, ex-vivo microbiological design to assess bacterial retention and antimicrobial efficacy. Participants are stratified by age (children and adults) and randomized to receive either an eco-friendly charcoal-infused toothbrush or a standard nylon toothbrush. Allocation is managed using computer-generated random sequences concealed in sequentially numbered, opaque envelopes. To maintain blinding, laboratory outcome assessors are unaware of group assignment, and participants are instructed not to disclose their intervention to the assessment team.
Standardized Usage Protocol
To minimize variability in bacterial load due to behavioral factors, all participants adhere to a strict hygiene protocol:
- Brushing Technique: Participants brush twice daily (morning and evening) for two minutes using a standardized method (45-degree angle to the gingiva with short back-and-forth strokes, and vertical strokes for anterior lingual surfaces).
- Storage and Maintenance: Post-brushing, bristles are rinsed under running water without digital manipulation. Toothbrushes must be stored upright, uncovered, and positioned at least two feet away from sanitary fixtures (e.g., toilets) to minimize aerosol contamination.
- Restrictions: The use of antimicrobial mouthrinses, medicated toothpastes, or bristle covers is prohibited during the active study phases.
Sample Collection Timeline
The study involves two distinct usage periods separated by a washout phase:
- Phase 1 (24-Hour Assessment): Participants use the assigned toothbrush for one day, followed by immediate return in a sterile pouch.
- Washout: A 7-day period occurs where participants revert to their non-study oral hygiene routine.
- Phase 2 (7-Day Assessment): Participants receive a new toothbrush of the same allocation, use it for 7 days, and return it in a sterile pouch for analysis.
Microbiological Analysis Returned samples are processed under aseptic laboratory conditions. Approximately one-third of the bristle field is excised using sterile instrumentation and transferred to test tubes containing 5 mL of sterile saline. The tubes are agitated to elute adherent microorganisms into suspension. A 0.1 mL aliquot is inoculated onto blood agar plates using a sterile spreader.
Plates are incubated in anaerobic gas pack jars at 37°C. Colony Forming Units (CFUs) are quantified after 48 hours of incubation to determine total bacterial load. Additionally, the intrinsic antimicrobial activity of the bristles is evaluated by measuring the zone of inhibition (in millimeters) surrounding bristle samples placed on agar plates after 7days of incubation.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Cairo, Egypt, 11585
- Dental clinic
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Participants free of any systemic diseases.
- Participants falling into one of two specific age groups:
A) Children aged 8 to 11 years.
B) Adults aged 18 to 35 years.
- Willingness to use the assigned toothbrush type (Eco-friendly charcoal or standard nylon).
- Ability to follow study instructions regarding brushing technique and storage.
Exclusion Criteria:
- Patients with open carious lesions.
- Participants with poor oral hygiene, defined as plaque index scores greater than 2.
- Participants with severe gingivitis, defined as gingival index score greater than 2.
- Current throat infections.
- Irregular brushing frequency (not brushing twice daily).
- Current use of mouthwash or antibacterial toothpastes.
- Current smokers.
- Medically compromised individuals.
- Unwillingness to use a charcoal Eco-friendly toothbrush.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Antimicrobial effect of Eco-friendly tooth brush in children
this arm will use the Eco-friendly toothbrush and will be evaluated for its antimicrobial effect
|
it is an eco-friendly charcoal toothbrush assumed to have antibacterial property in children
|
|
Experimental: Antimicrobial effect of Eco-friendly tooth brush in adults
this arm will use the eco-friendly toothbrush and tested for its antimicrobial effect in adults
|
to see the antimicrobial effect of eco-friendly toothbrush in adults
|
|
Active Comparator: Nylon bristles toothbrush in children
this arm will use the nylon toothbrush bristles and be evaluated for its antibacterial effect
|
a normal man made toothbrush used by children
|
|
Active Comparator: nylon toothbrush bristles in adults
this arm will use the nylon bristles toothbrush and be evaluated for its antimicrobial effect
|
a normal man made toothbrush used by adults
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Colony-forming units (CFU)
Time Frame: 10 days
|
Bacterial load will be quantified as CFU per milliliter (CFU/mL) from toothbrush bristles after 1 day and 1 week of use.
One-third of the bristles will be aseptically cut, placed in 5 mL sterile saline, mixed to elute bacteria, then 0.1 mL will be plated onto blood agar.
Plates will be incubated under anaerobic conditions for 48 hours, then colonies will be counted and recorded as CFU/mL.
|
10 days
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- SUEZ Med - IRB Approval No: 95
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Supporting Information Type
- ICF
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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