Manual ToothbrushNCT06554782
Children's Compliance With Toothbrushing Using Manual U-shaped Toothbrush Versus Regular Toothbrush
A study testing manual u-shaped toothbrush in people with Manual Toothbrush, run by Cairo University.
Trial summary
To assess the child's compliance towards manual U-shaped toothbrush versus regular manual toothbrush. Read more about this study
- Who is it for?
- Ages 5 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Manual Toothbrush
- What is being tested?
- manual u-shaped toothbrush
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- No sites listed yet
- Study dates
- Apr 2025to Jan 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 5 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- children aged 5 to 10 years, in good general health, and medically free.
- Cooperative patients who will comply with follow-ups.
- Parents who accept to sign informed consent.
Who cannot join
- Children with fixed or removable orthodontic appliances.
- Children with a physical disability, and medical disability.
- Children who will be unable to attend follow-up visits.
- Parents refuse to give written formed consent.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Children's Compliance With Toothbrushing Using Manual U-shaped Toothbrush Versus Regular Manual Toothbrush
To assess the child's compliance towards manual U-shaped toothbrush versus regular manual toothbrush.
Read the detailed description
Research has shown that an undesirably high proportion of communities find thorough toothbrushing with a standard manual toothbrush challenging to achieve a plaque-free state, as evidenced by high worldwide gingivitis and periodontitis. This is consistent with investigations that reveal insufficient frequency of brushing, poor brushing technique, and inadequate brushing session duration when compared with standard-of-care professional recommendations.
The U-shaped brush is an intervention chosen for the present study because it can attract children's attention and make brushing fun and routine. With bristles angled at 45° and available in various sizes according to age, the U-shaped brush is useful for removing plaque. It can be used starting at age three or older. It is dependable for children because its two-sided design can clean the upper and lower arches in one motion. Since design affects plaque removal to varying degrees, various authors have examined the effects of different toothbrush designs on plaque removal.
- Conditions
- Manual Toothbrush
- Being tested
- manual u-shaped toothbrush
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
manual u-shaped toothbrushDevice
manual u-shaped toothbrush with bristles angled 45 degrees to brush upper and lower teeth at the same time
| Study group | Role | What they receive |
|---|---|---|
| manual u-shaped toothbrush | Experimental | manual u-shaped toothbrush with arm angled 45 degrees to brush upper and lower arch at the same time Receives: Device: manual u-shaped toothbrush |
| manual toothbrush | Experimental | manual toothbrush with soft bristles and circular movement to clean each quadrant separately Receives: Device: manual u-shaped toothbrush |
What is being measured
The primary outcome is the main question the study is designed to answer.
compliance of patient
questioning the parents about compliance either yes or no
Measured: 1 week
Secondary outcomes (1)
full mouth plaque score
Turesky modified Quigley-Hein plaque index technique index score: total score/number of surfaces examined 0-1= low >2= high
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2024
- Study startApr 2025 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionJan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Manual ToothbrushStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 47 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rana Sobhy Saeed, Cairo University
- Investigators
- Randa Youssef AbdelGawad, professor, Study director, Cairo UniversityRana Tarek Bartaw, assistant professor, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06554782
- Sponsor's protocol ID
- U-shaped toothbrush
- Status last verified
- Feb 2025
- First submitted
- 2 Aug 2024
- Last updated
- 11 Feb 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ashkenazi M, Bidoosi M, Levin L. Factors associated with reduced compliance of children to dental preventive measures. Odontology. 2012 Jul;100(2):241-8. doi: 10.1007/s10266-011-0034-1. Epub 2011 Jun 23.
PubMed 21698350Davidovich E, Ccahuana-Vasquez RA, Timm H, Grender J, Cunningham P, Zini A. Randomised clinical study of plaque removal efficacy of a power toothbrush in a paediatric population. Int J Paediatr Dent. 2017 Nov;27(6):558-567. doi: 10.1111/ipd.12298. Epub 2017 May 11.
PubMed 28494116
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Children's Compliance With Toothbrushing Using Manual U-shaped Toothbrush Versus Regular Manual Toothbrush
- ClinicalTrials.gov ID
- NCT06554782
- Acronym / sponsor ID
- U-shaped toothbrush
- Conditions
- Manual Toothbrush
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 47 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Apr 2025 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Jan 2026 (estimated)
- First posted
- 15 Aug 2024 (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.
To assess the child's compliance towards manual U-shaped toothbrush versus regular manual toothbrush.
Detailed description
Research has shown that an undesirably high proportion of communities find thorough toothbrushing with a standard manual toothbrush challenging to achieve a plaque-free state, as evidenced by high worldwide gingivitis and periodontitis. This is consistent with investigations that reveal insufficient frequency of brushing, poor brushing technique, and inadequate brushing session duration when compared with standard-of-care professional recommendations.
The U-shaped brush is an intervention chosen for the present study because it can attract children's attention and make brushing fun and routine. With bristles angled at 45° and available in various sizes according to age, the U-shaped brush is useful for removing plaque. It can be used starting at age three or older. It is dependable for children because its two-sided design can clean the upper and lower arches in one motion. Since design affects plaque removal to varying degrees, various authors have examined the effects of different toothbrush designs on plaque removal.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| manual u-shaped toothbrush | Experimental | Device: manual u-shaped toothbrushmanual u-shaped toothbrush with arm angled 45 degrees to brush upper and lower arch at the same time |
| manual toothbrush | Experimental | Device: manual u-shaped toothbrushmanual toothbrush with soft bristles and circular movement to clean each quadrant separately |
Who may qualify
- Ages
- 5 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- children aged 5 to 10 years, in good general health, and medically free.
- Cooperative patients who will comply with follow-ups.
- Parents who accept to sign informed consent.
Key exclusion criteria (4 listed)
- Children with fixed or removable orthodontic appliances.
- Children with a physical disability, and medical disability.
- Children who will be unable to attend follow-up visits.
- Parents refuse to give written formed consent.
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 |
|---|---|---|
| manual u-shaped toothbrushmanual u-shaped toothbrush with bristles angled 45 degrees to brush upper and lower teeth at the same time | Device | manual toothbrush, manual u-shaped toothbrush |
Primary outcome
compliance of patient
Time frame: 1 week
questioning the parents about compliance either yes or no
1 secondary outcome
full mouth plaque score
Time frame: 1 week
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2025.
- Background: PubMed 21698350Ashkenazi M, Bidoosi M, Levin L. Factors associated with reduced compliance of children to dental preventive measures. Odontology. 2012 Jul;100(2):241-8. doi: 10.1007/s10266-011-0034-1. Epub 2011 Jun 23.
- Results publication: PubMed 28494116Davidovich E, Ccahuana-Vasquez RA, Timm H, Grender J, Cunningham P, Zini A. Randomised clinical study of plaque removal efficacy of a power toothbrush in a paediatric population. Int J Paediatr Dent. 2017 Nov;27(6):558-567. doi: 10.1111/ipd.12298. Epub 2017 May 11.
- 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.
Randa Youssef AbdelGawad, professor study director
Cairo University
Rana Tarek Bartaw, assistant professor study director
Cairo University
Questions about this trial
What is this clinical trial studying?
A study testing manual u-shaped toothbrush in people with Manual Toothbrush, run by Cairo University.
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 3 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: opening soon, as of the sponsor's last update on 11 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rana Sobhy Saeed, bachelor (01156633838, ranaelagamy@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
compliance of patient (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06554782, which also lists 2 linked publications.
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 11 Feb 2025.