NCT07563413

Brief Summary

Oral hygiene practices are fundamental to maintaining oral health, preventing dental plaque accumulation, halitosis, stains, gingival and periodontal diseases, and improving overall quality of life. Dental plaque plays a central role in the initiation of caries and periodontal disease by lowering enamel surface pH and promoting hydroxyapatite dissolution. Toothbrushing with toothpaste remains the most widely accepted and effective method for mechanical plaque control, with its efficacy influenced by toothbrush design, brushing technique, and duration. Recently, charcoal-infused toothbrushes have been introduced as an alternative oral hygiene aid. These brushes incorporate binchotan charcoal into nylon bristles, purportedly offering antimicrobial, deodorizing, and stain-removal properties by increasing oral pH, reducing bacterial load, and absorbing stain causing compounds. Despite growing commercial interest, scientific evidence supporting their clinical efficacy remains limited. Therefore, this randomized controlled clinical trial aims to evaluate and compare the effectiveness of charcoal-infused toothbrushes versus conventional toothbrushes in plaque reduction and stain removal among Egyptian adults. Plaque levels will be assessed using the Turesky and Gilmore modification of the Quigley-Hein Plaque Index, while stain removal efficacy will be evaluated through spectrophotometric color measurements using a Vita Easyshade device. Outcomes will be recorded at baseline and after four weeks of twice-daily brushing with standardized fluoride toothpaste. This study addresses a clear gap in the literature by providing clinical evidence on the effectiveness of charcoal-containing toothbrushes, thereby supporting evidence-based recommendations for modern oral hygiene practices.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2026

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2026

Completed
19 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 20, 2026

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 27, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 4, 2026

Completed
Last Updated

May 4, 2026

Status Verified

April 1, 2026

Enrollment Period

1 month

First QC Date

April 27, 2026

Last Update Submit

April 27, 2026

Conditions

Keywords

charcoal,toothbrush,plaque,stains

Outcome Measures

Primary Outcomes (1)

  • The plaque score

    (Turesky and Gilmore modification of Quigley Hein plaque index)

    4 weeks

Secondary Outcomes (1)

  • Stain removal efficacy , measured by color change

    4 weeks

Study Arms (2)

conventional toothbrush

ACTIVE COMPARATOR

Participants in the control group used a conventional nylon-bristled toothbrush . They were instructed to brush twice daily for 2 minutes using a standardized fluoride toothpaste and identical oral hygiene instructions. The use of any additional oral hygiene or whitening products was also prohibited throughout the 4-week study period.

Procedure: charcoal toothbrush

charcoal toothbrush

EXPERIMENTAL

Participants in the test group used a charcoal-infused toothbrush containing activated charcoal incorporated into nylon bristles. They were instructed to brush twice daily for 2 minutes using a standardized fluoride toothpaste and the same standardized brushing instructions provided at baseline. No additional oral hygiene aids or whitening products were permitted during the 4-week study period.

Procedure: charcoal toothbrush

Interventions

Participants were randomly assigned to either a charcoal-infused toothbrush (test group) or a conventional nylon toothbrush (control group). Both groups were instructed to brush twice daily for 2 minutes using standardized fluoride toothpaste and to follow the same brushing instructions provided at baseline. No additional oral hygiene aids or whitening products were allowed during the 4-week study period. Compliance was encouraged through regular reminders, and clinical assessments were performed at baseline and after 4 weeks.

charcoal toothbrushconventional toothbrush

Eligibility Criteria

Age21 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Subjects who will be given a consent to participate in the study, between 21 to 50 years old, with an original plaque score recorded above 2, and presence of at least twenty long lasting natural teeth (excluding wisdom tooth, teeth with orthodontic appliances) were included in the study.

You may not qualify if:

  • Subjects with any physical constraints that might prevent normal oral hygiene procedures, history of sensitivity to toothpaste, use of interdental aids (interdental floss, mouth rinses, etc), pregnant or breastfeeding females, subjects under medication such as anti inflammatory, antiepileptic and antihypertensive, medically compromised patients (systemic diseases such as cardiovascular disease, diabetes, etc), evidences of gingival or periodontal diseases or trauma at baseline, any lesion of hard and soft tissue, were excluded from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentistry Cairo University

Cairo, Egypt

Location

MeSH Terms

Conditions

Dental PlaqueAnthrax

Condition Hierarchy (Ancestors)

Dental DepositsTooth DiseasesStomatognathic DiseasesBacillaceae InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Participants were randomly assigned to either a charcoal-infused toothbrush (test group) or a conventional nylon toothbrush (control group). Both groups were instructed to brush twice daily for 2 minutes using standardized fluoride toothpaste and to follow the same brushing instructions provided at baseline. No additional oral hygiene aids or whitening products were allowed during the 4-week study period. Compliance was encouraged through regular reminders, and clinical assessments were performed at baseline and after 4 weeks.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer at faculty of dentistry Cairo university

Study Record Dates

First Submitted

April 27, 2026

First Posted

May 4, 2026

Study Start

January 1, 2026

Primary Completion

February 1, 2026

Study Completion

February 20, 2026

Last Updated

May 4, 2026

Record last verified: 2026-04

Locations