Dental PlaqueNCT06288581
U Shaped Toothbrush in Removing Plaque in Children
A study testing Traditional toothbrush group and U shaped toothbrush group in people with Dental Plaque, run by Damascus University at 1 site in Syria.
Trial summary
The aim of this study is to evaluate the effectiveness of a U-shaped toothbrush in removing plaque in preschool children which can be a simple, acceptable, and effective way to remove plaque in children in order to improve their oral health in the absence of parental supervision. Read more about this study
- Who is it for?
- Ages 4 to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Plaque
- What is being tested?
- Traditional toothbrush group and U shaped toothbrush group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSyria
- Study dates
- 1 Feb 2024to 15 Aug 2024
- 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 4 to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Medically free children. Complete temporary occlusion (no missing temporary teeth). The parents' approval for the child to enter the study.
Who cannot join
- Children with limited ability to communicate. Children with motor disabilities.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluating the Effectiveness of a U-shaped Toothbrush in Removing Plaque In Pre-school Children
The aim of this study is to evaluate the effectiveness of a U-shaped toothbrush in removing plaque in preschool children which can be a simple, acceptable, and effective way to remove plaque in children in order to improve their oral health in the absence of parental supervision.
Children accepted in the study will be randomly divided into two groups:
The traditional toothbrush group and the U-shaped toothbrush group, All children aged four to five years will have their plaque assessed with the Turesky Modified Quigley Hein Index (TMQH)
Read the detailed description
This study will evaluate the effectiveness U-shaped toothbrush in removing plaque and improving oral health. Children were randomly assigned to one of the following groups:
Group A: children in this group will use a traditional brush first to clean their teeth then will use U shaped brush later.
Group B: children in this group will use a U-shaped brush first to clean their teeth then will use a traditional brush later The plaque will be assessed by a blinded evaluator using the Turesky Modified Quigley Hein index (TMQH) in both groups at 4 different times(T0): before brush (T1): after brush (T2): a week after use (T3): a month of use The toothbrush will be changed after one month of use.
- Conditions
- Dental Plaque
- Being tested
- Traditional toothbrush group, U shaped toothbrush group
- Keywords
- U shaped toothbrush, Traditional toothbrush, Plaque removal, Oral hygiene, Pre-schooled children
- Medical subject headings
- Dental Plaque
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Traditional toothbrush groupOther
Children in this group will use a traditional brush with a traditional toothpaste first to clean their teeth then after 30 days they will use a U shaped brush with a traditional toothpaste for another 30 days.
U shaped toothbrush groupOther
Children in this group will use a U shaped brush with a traditional toothpaste first to clean their teeth then after 30 days they will use a traditional brush with a traditional toothpaste for another 30 days.
| Study group | Role | What they receive |
|---|---|---|
| Traditional toothbrush group | Experimental | Children in this group will use a traditional brush first to clean their teeth then will use U shaped brush later. Receives: Other: Traditional toothbrush group |
| U shaped toothbrush group | Experimental | children in this group will use a U-shaped brush first to clean their teeth then will use traditional brush later Receives: Other: U shaped toothbrush group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changing in plaque index
0 No plaque,1 Isolated flecks of plaque at the gingival margin, 2 A continuous band of plaque up to 1mm at the gingival margin, 3 Plaque greater than 1mm in width and covering up to one third of the tooth surface, 4 Plaque covering from one thirds to two thirds of the tooth surface, and 5 Plaque covering more than two thirds of the tooth surface
Measured: Plaque index will be measured before brushing (T0) and after brushing in both groups on the first day (T1), a week after use (T2), and after a month of use (T3) with each toothbrush
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2024
- Study start1 Feb 2024
- Primary completion1 May 2024
- Study completion15 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental PlaqueStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Damascus University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06288581
- Sponsor's protocol ID
- UDDS-Pedo-02-2024
- Status last verified
- Sep 2024
- First submitted
- 25 Feb 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: only with contacting the main researcher
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Effectiveness of a U-shaped Toothbrush in Removing Plaque In Pre-school Children
- ClinicalTrials.gov ID
- NCT06288581
- Acronym / sponsor ID
- UDDS-Pedo-02-2024
- Conditions
- Dental Plaque
- Keywords
- U shaped toothbrush, Traditional toothbrush, Plaque removal, Oral hygiene, Pre-schooled children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Damascus UniversityUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 1 May 2024 (actual)
- Study completion
- 15 Aug 2024 (actual)
- First posted
- 1 Mar 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.
The aim of this study is to evaluate the effectiveness of a U-shaped toothbrush in removing plaque in preschool children which can be a simple, acceptable, and effective way to remove plaque in children in order to improve their oral health in the absence of parental supervision.
Children accepted in the study will be randomly divided into two groups:
The traditional toothbrush group and the U-shaped toothbrush group, All children aged four to five years will have their plaque assessed with the Turesky Modified Quigley Hein Index (TMQH)
Detailed description
This study will evaluate the effectiveness U-shaped toothbrush in removing plaque and improving oral health. Children were randomly assigned to one of the following groups:
Group A: children in this group will use a traditional brush first to clean their teeth then will use U shaped brush later.
Group B: children in this group will use a U-shaped brush first to clean their teeth then will use a traditional brush later The plaque will be assessed by a blinded evaluator using the Turesky Modified Quigley Hein index (TMQH) in both groups at 4 different times(T0): before brush (T1): after brush (T2): a week after use (T3): a month of use The toothbrush will be changed after one month of use.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Traditional toothbrush group | Experimental | Other: Traditional toothbrush groupChildren in this group will use a traditional brush first to clean their teeth then will use U shaped brush later. |
| U shaped toothbrush group | Experimental | Other: U shaped toothbrush groupchildren in this group will use a U-shaped brush first to clean their teeth then will use traditional brush later |
Who may qualify
- Ages
- 4 to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Medically free children. Complete temporary occlusion (no missing temporary teeth). The parents' approval for the child to enter the study.
Key exclusion criteria (1 listed)
- Children with limited ability to communicate. Children with motor disabilities.
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 |
|---|---|---|
| Traditional toothbrush groupChildren in this group will use a traditional brush with a traditional toothpaste first to clean their teeth then after 30 days they will use a U shaped brush with a traditional toothpaste for another 30 days. | Other | Traditional toothbrush group |
| U shaped toothbrush groupChildren in this group will use a U shaped brush with a traditional toothpaste first to clean their teeth then after 30 days they will use a traditional brush with a traditional toothpaste for another 30 days. | Other | U shaped toothbrush group |
Primary outcome
Changing in plaque index
Time frame: Plaque index will be measured before brushing (T0) and after brushing in both groups on the first day (T1), a week after use (T2), and after a month of use (T3) with each toothbrush
0 No plaque,1 Isolated flecks of plaque at the gingival margin, 2 A continuous band of plaque up to 1mm at the gingival margin, 3 Plaque greater than 1mm in width and covering up to one third of the tooth surface, 4 Plaque covering from one thirds to two thirds of the tooth surface, and 5 Plaque covering more than two thirds of the tooth surface
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 19 Sep 2024.
- Individual participant dataSharing planned: No. only with contacting the main researcher
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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 Traditional toothbrush group and U shaped toothbrush group in people with Dental Plaque, run by Damascus University at 1 site in Syria.
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 1 inclusion and 1 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 19 Sep 2024. 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 Syria. 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?
Changing in plaque index (time frame: Plaque index will be measured before brushing (T0) and after brushing in both groups on the first day (T1), a week after use (T2), and after a month of use (T3) with each toothbrush). 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 19 Sep 2024.