Effectiveness of ToothbrushNCT07373249
The Study of Parental Toothbrushing Efficacy Assessment With Triple-Headed and Single-Headed Toothbrushes in Preschool Children With Developmental Disability
A study testing Triple-headed toothbrush in people with Effectiveness of Toothbrush, run by Mahidol University at 1 site in Thailand.
Trial summary
The Objectives 1. To evaluate the efficacy of dental plaque removal between triple-headed and single-headed toothbrushes in preschool children with developmental disabilities through parental brushing 2. To assess the parental satisfaction with triple-headed toothbrushes Read more about this study
- Who is it for?
- Ages 3 to 6 years
- Conditions the study is for
- Effectiveness of Toothbrush
- What is being tested?
- Triple-headed toothbrush
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteThailand
- Study dates
- 17 Jun 2025to 9 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Developmental disability children aged 3 to 6 years old who have full primary dentition.
- The caregivers who responsible for brushing their child's teeth that must be the same person throughout the study and able to attend both study sessions
Who cannot join
- Developmental disability children who have periodontal disease, soft tissue ulcers or gingival abscess.
- Developmental disability children who have missing tooth more than one tooth per sextant.
- Developmental disability children who have definitely negative behavior (Frankl behavior rating scale one) (89) during oral examination
- Parents of Developmental disability children who have a physical or mental disability which may influence to their brushing ability.
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Tung Song Hong community center for preschool mentally retarded and the Dental Department at Bangkruai Hospital
Bangkok
About this study
Official title: The Study of Parental Toothbrushing Efficacy Assessment With Triple-Headed and Single-Headed Toothbrushes in Preschool Children With Developmental Disability: A Randomized Crossover Study
The Objectives
- To evaluate the efficacy of dental plaque removal between triple-headed and single-headed toothbrushes in preschool children with developmental disabilities through parental brushing
- To assess the parental satisfaction with triple-headed toothbrushes
Read the detailed description
This study was a single-blind, randomized crossover study. 24 Parents of children with developmental disabilities (DD) were invited to participate in the study. Baseline data including demographic information, plaque index, and dmft, were collected. Participants were randomly assigned to receive their first toothbrush, either a single-head toothbrush (Berman®; soft and flat bristles for preschool children) or a triple-head toothbrush (Dr. Barman's Superbrush®; soft and flat bristles, size 0-6 years). Parents received toothbrushing instruction via a video clip according to the randomly assigned sequence of toothbrush type. Parents were then allowed to perform toothbrushing for their children. The quality of toothbrushing performance for each sextant was evaluated by the examiner using a toothbrushing performance form. Overall toothbrushing time was also recorded.
All participants were advised to use their own toothbrush during the washout period. After a four-week washout period, participants crossed over to the alternate toothbrush type, and all procedures were repeated. At the end of the study, parents completed a satisfaction questionnaire regarding the triple-headed toothbrush.
- Conditions
- Effectiveness of Toothbrush
- Being tested
- Triple-headed toothbrush
- Keywords
- TRIPLE-HEADED TOOTHBRUSH, PLAQUE REMOVAL, DEVELOPMENTAL DISABILITY, SINGLE-HEADED TOOTHBRUSH
- Medical subject headings
- Developmental Disabilities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Triple-headed toothbrushDevice
The triple-headed toothbrush has been introduced to enhance brushing effectiveness as a design of three sides bristles, with each head capable of cleaning the buccal, lingual, and occlusal surfaces simultaneously. It is particularly suitable for individuals with limited manual skills, such as those with physical and mental handicaps, young or preschool children, especially important for caregivers when patient cooperation during brushing is limited.The round-end design is beneficial for easier brushing, reducing time, and improving cleaning efficiency, as proven in numerous studies
| Study group | Role | What they receive |
|---|---|---|
| Triple and single headed toothbrush | Experimental | Crossover study compared effectiveness of tripled and single headed toothbrush Receives: Device: Triple-headed toothbrush |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dental Plaque Reduction Score Assessed by the Greene and Vermillion Plaque Index
Dental plaque removal efficacy was assessed by the change in dental plaque scores measured using the Greene and Vermillion Plaque Index (score range: 0-3). Dental plaque was disclosed using Disclosing PCA 260 Liquid Solution (Curaprox, Switzerland) and evaluated on the labial/buccal and lingual/palatal surfaces of six primary teeth (teeth no. 51, 55, 65, 71, 75, and 85). Dental plaque scores were recorded immediately before and immediately after parent-performed toothbrushing using either a triple-headed toothbrush or a single-headed toothbrush, according to a randomized crossover design. The outcome measure was calculated as the difference between pre-brushing and post-brushing plaque index scores for each toothbrush type. Mean plaque score changes were compared between toothbrush types. A randomized crossover design with a four-week washout period was used to minimize carryover effects. Brushing time (in seconds) was recorded as a secondary parameter to support interpretation of pla
Measured: 4 weeks per participant
Secondary outcomes (1)
Parental Satisfaction With the Use of a Triple-Headed Toothbrush
Parental satisfaction with the triple-headed toothbrush was assessed using a self-administered satisfaction questionnaire completed after parents used the triple-headed toothbrush to brush their child's teeth.
The questionnaire consisted of two sections. The first section collected parent demographic information, including age, sex, educational level, and relationship to the child with developmental disability. The second section assessed overall satisfaction with the triple-headed toothbrush, including ease of use, perceived effectiveness, and overall acceptance. Satisfaction responses were summarized using descriptive statistics.
Measured: 4 weeks per participant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2026
- Study start17 Jun 2025
- Primary completion9 Oct 2025
- Study completion9 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Effectiveness of ToothbrushStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jantra Jitngamkusol, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07373249
- Sponsor's protocol ID
- MU-DT/PY-lRB 2024/ 060.2409
- Status last verified
- Jan 2026
- First submitted
- 11 Jan 2026
- Last updated
- 28 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Study of Parental Toothbrushing Efficacy Assessment With Triple-Headed and Single-Headed Toothbrushes in Preschool Children With Developmental Disability: A Randomized Crossover Study
- ClinicalTrials.gov ID
- NCT07373249
- Acronym / sponsor ID
- MU-DT/PY-lRB 2024/ 060.2409
- Conditions
- Effectiveness of Toothbrush
- Keywords
- TRIPLE-HEADED TOOTHBRUSH, PLAQUE REMOVAL, DEVELOPMENTAL DISABILITY, SINGLE-HEADED TOOTHBRUSH
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- 17 Jun 2025 (actual)
- Primary completion
- 9 Oct 2025 (actual)
- Study completion
- 9 Oct 2025 (actual)
- First posted
- 28 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Objectives
- To evaluate the efficacy of dental plaque removal between triple-headed and single-headed toothbrushes in preschool children with developmental disabilities through parental brushing
- To assess the parental satisfaction with triple-headed toothbrushes
Detailed description
This study was a single-blind, randomized crossover study. 24 Parents of children with developmental disabilities (DD) were invited to participate in the study. Baseline data including demographic information, plaque index, and dmft, were collected. Participants were randomly assigned to receive their first toothbrush, either a single-head toothbrush (Berman®; soft and flat bristles for preschool children) or a triple-head toothbrush (Dr. Barman's Superbrush®; soft and flat bristles, size 0-6 years). Parents received toothbrushing instruction via a video clip according to the randomly assigned sequence of toothbrush type. Parents were then allowed to perform toothbrushing for their children. The quality of toothbrushing performance for each sextant was evaluated by the examiner using a toothbrushing performance form. Overall toothbrushing time was also recorded.
All participants were advised to use their own toothbrush during the washout period. After a four-week washout period, participants crossed over to the alternate toothbrush type, and all procedures were repeated. At the end of the study, parents completed a satisfaction questionnaire regarding the triple-headed toothbrush.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Triple and single headed toothbrush | Experimental | Device: Triple-headed toothbrushCrossover study compared effectiveness of tripled and single headed toothbrush |
Who may qualify
- Ages
- 3 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Developmental disability children aged 3 to 6 years old who have full primary dentition.
- The caregivers who responsible for brushing their child's teeth that must be the same person throughout the study and able to attend both study sessions
Key exclusion criteria (4 listed)
- Developmental disability children who have periodontal disease, soft tissue ulcers or gingival abscess.
- Developmental disability children who have missing tooth more than one tooth per sextant.
- Developmental disability children who have definitely negative behavior (Frankl behavior rating scale one) (89) during oral examination
- Parents of Developmental disability children who have a physical or mental disability which may influence to their brushing ability.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Triple-headed toothbrushThe triple-headed toothbrush has been introduced to enhance brushing effectiveness as a design of three sides bristles, with each head capable of cleaning the buccal, lingual, and occlusal surfaces simultaneously. It is particularly suitable for individuals with limited manual skills, such as those with physical and mental handicaps, young or preschool children, especially important for caregivers when patient cooperation during brushing is limited.The round-end design is beneficial for easier brushing, reducing time, and improving cleaning efficiency, as proven in numerous studies | Device | Triple and single headed toothbrush |
Primary outcome
Dental Plaque Reduction Score Assessed by the Greene and Vermillion Plaque Index
Time frame: 4 weeks per participant
Dental plaque removal efficacy was assessed by the change in dental plaque scores measured using the Greene and Vermillion Plaque Index (score range: 0-3). Dental plaque was disclosed using Disclosing PCA 260 Liquid Solution (Curaprox, Switzerland) and evaluated on the labial/buccal and lingual/palatal surfaces of six primary teeth (teeth no. 51, 55, 65, 71, 75, and 85). Dental plaque scores were recorded immediately before and immediately after parent-performed toothbrushing using either a triple-headed toothbrush or a single-headed toothbrush, according to a randomized crossover design. The outcome measure was calculated as the difference between pre-brushing and post-brushing plaque index scores for each toothbrush type. Mean plaque score changes were compared between toothbrush types. A randomized crossover design with a four-week washout period was used to minimize carryover effects. Brushing time (in seconds) was recorded as a secondary parameter to support interpretation of pla
1 secondary outcome
Parental Satisfaction With the Use of a Triple-Headed Toothbrush
Time frame: 4 weeks per participant
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Triple-headed toothbrush in people with Effectiveness of Toothbrush, run by Mahidol University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dental Plaque Reduction Score Assessed by the Greene and Vermillion Plaque Index (time frame: 4 weeks per participant). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2026.