Oral HygieneNCT03989479
Effectiveness of T-shaped Toothbrush
A study testing Brushing demonstration using T shaped toothbrush and Brushing demonstration using conventional toothbrush in people with Oral Hygiene, run by University of Malaya.
Trial summary
This study evaluated the effectiveness of two manual toothbrushes, the T-shaped toothbrush (Denson™, Malaysia) and a conventional toothbrush (Kid's Soft Toothbrush, Colgate) in removing plaque and maintaining gingival health among 8-10-year old children. Read more about this study
- Who is it for?
- Ages 8 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Oral Hygiene
- What is being tested?
- Brushing demonstration using T shaped toothbrush and Brushing demonstration using conventional toothbrush
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Apr 2015to Jan 2016
- 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 8 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- good systemic health
- normal motor and cognitive development
Who cannot join
- acute intraoral lesion
- history of antibiotic and/ or antiseptic therapy in the past one month
- interproximal caries or restorations
- 3 or more missing teeth in one quadrant
About this study
Official title: The Effectiveness of T-shaped Toothbrush in Plaque Removal and Maintaining Gingival Health Among Children
This study evaluated the effectiveness of two manual toothbrushes, the T-shaped toothbrush (Denson™, Malaysia) and a conventional toothbrush (Kid's Soft Toothbrush, Colgate) in removing plaque and maintaining gingival health among 8-10-year old children.
Brushing demonstration was provided at baseline and reinforced at 2 weeks and 1 month interval.Plaque scores and gingival scores were measured at 2 weeks and 1 month and 3 months
Read the detailed description
T-shaped toothbrush (Denson™, Malaysia) was introduced that is designed to efficiently clean and reduce gingival inflammation. Unlike most common conventional manual toothbrush, this new toothbrush was designed to employ a vertical motion on all tooth surfaces which simulates the natural up and down movement of the hand, suggesting that this makes the brushing process to be more controlled and stable.
One hundred and ten participants were assigned randomly to conventional toothbrush (Kid's Soft Toothbrush, Colgate) as a control group, while another half were assigned the T-shaped toothbrush (Denson™, Malaysia) as an experimental group.
Gingival status was scored using the Loe and Silness Gingival Index 25. The amount of plaque was scored using the modified Quigley and Hein Plaque Index (TQHI) 26. Both indices were recorded at 6 sites around all the teeth (mesiobuccal, midbuccal, distobuccal, mesiopalatal, midpalatal, distopalatal). All teeth were included except teeth with prosthetic crowns or cervical restorations.
One hundred children completed the study.
- Conditions
- Oral Hygiene
- Being tested
- Brushing demonstration using T shaped toothbrush, Brushing demonstration using conventional toothbrush
- Keywords
- toothbrush, plaque removal, gingival health
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brushing demonstration using T shaped toothbrushBehavioural
Brushing demonstration given at baseline and reinforced at 2 weeks and 1 month
Brushing demonstration using conventional toothbrushBehavioural
Brushing demonstration given at baseline and reinforced at 2 weeks and 1 month
| Study group | Role | What they receive |
|---|---|---|
| Conventional Toothbrush | Active comparator | Brushing with conventional Kid's Soft Toothbrush, Colgate (5-9-year-old) Receives: Behavioral: Brushing demonstration using conventional toothbrush |
| T-shaped Toothbrush | Experimental | Brushing with T-shaped toothbrush (Denson™, Malaysia) Receives: Behavioral: Brushing demonstration using T shaped toothbrush |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plaque score
Plaque score measurement performed at baseline, after 2 weeks, 1 month and 3 months.
Plaque score measurement (amount of plaque) was recorded on both the buccal and lingual sides of all teeth using the modified Quigley and Hein Plaque Index (Turesky et al., 1970) {0-no plaque present, 1- separate flecks of plaque at the cervical margin, 2- a thin, continous band of plaque at the cervical margin, 3- a band of plaque wider than 1mm but covering less than 1/3 of the surface, 4- plaque covering at least 1/3 but less than 2/3 of the surface, 5- plaque covering more than 2/3 of the surface}. Each tooth was scored in six areas: mesiofacial, midfacial, distofacial, mesiolingual, midlingual and distolingual. The minimum and maximum score per tooth was 0 and 30. The scores for each participant was summed and divided by the total number of measurements (number of teeth scored multiplied by six). Higher scores indicated worse outcome.
Measured: 3 months
Gingival status
Gingival status measurement performed at baseline, after 2 weeks, 1 month and 3 months.
Gingival status (gingival inflammation) was scored using the Loe and Silness (Loe \& Silness, 1963) {0-absence of inflammation, 1- mild inflammation, 2- moderate inflammation, 3- severe inflammation}. Each tooth was scored in six areas: mesiofacial, midfacial, distofacial, mesiolingual, midlingual and distolingual. The minimum and maximum score per tooth was 0 and 18. The scores for each participant was calculated by adding all the individual plaque scores and dividing this sum by the total number of measurements (number of teeth scored multiplied by six). Higher scores indicated worse outcome
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2019
- Study startApr 2015
- Primary completionSep 2015
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Oral HygieneStudies 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
- Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Malaya
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shani Ann Mani, MDS, Study chair, Faculty of Dentistry, University of Malaya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03989479
- Sponsor's protocol ID
- T1
- Status last verified
- Jun 2019
- First submitted
- 13 Jun 2019
- Last updated
- 21 Jun 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Mamat N, Mani SA, Danaee M. T-shaped toothbrush for plaque removal and gingival health in children: a randomized controlled trial. BMC Oral Health. 2022 Apr 7;22(1):113. doi: 10.1186/s12903-022-02137-x.
PubMed 35392881
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of T-shaped Toothbrush in Plaque Removal and Maintaining Gingival Health Among Children
- ClinicalTrials.gov ID
- NCT03989479
- Acronym / sponsor ID
- T1
- Conditions
- Oral Hygiene
- Keywords
- toothbrush, plaque removal, gingival health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of MalayaUniversity, hospital or other
- Study start
- Apr 2015 (actual)
- Primary completion
- Sep 2015 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 18 Jun 2019 (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.
This study evaluated the effectiveness of two manual toothbrushes, the T-shaped toothbrush (Denson™, Malaysia) and a conventional toothbrush (Kid's Soft Toothbrush, Colgate) in removing plaque and maintaining gingival health among 8-10-year old children.
Brushing demonstration was provided at baseline and reinforced at 2 weeks and 1 month interval.Plaque scores and gingival scores were measured at 2 weeks and 1 month and 3 months
Detailed description
T-shaped toothbrush (Denson™, Malaysia) was introduced that is designed to efficiently clean and reduce gingival inflammation. Unlike most common conventional manual toothbrush, this new toothbrush was designed to employ a vertical motion on all tooth surfaces which simulates the natural up and down movement of the hand, suggesting that this makes the brushing process to be more controlled and stable.
One hundred and ten participants were assigned randomly to conventional toothbrush (Kid's Soft Toothbrush, Colgate) as a control group, while another half were assigned the T-shaped toothbrush (Denson™, Malaysia) as an experimental group.
Gingival status was scored using the Loe and Silness Gingival Index 25. The amount of plaque was scored using the modified Quigley and Hein Plaque Index (TQHI) 26. Both indices were recorded at 6 sites around all the teeth (mesiobuccal, midbuccal, distobuccal, mesiopalatal, midpalatal, distopalatal). All teeth were included except teeth with prosthetic crowns or cervical restorations.
One hundred children completed the study.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional Toothbrush | Active comparator | Behavioral: Brushing demonstration using conventional toothbrushBrushing with conventional Kid's Soft Toothbrush, Colgate (5-9-year-old) |
| T-shaped Toothbrush | Experimental | Behavioral: Brushing demonstration using T shaped toothbrushBrushing with T-shaped toothbrush (Denson™, Malaysia) |
Who may qualify
- Ages
- 8 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- good systemic health
- normal motor and cognitive development
Key exclusion criteria (4 listed)
- acute intraoral lesion
- history of antibiotic and/ or antiseptic therapy in the past one month
- interproximal caries or restorations
- 3 or more missing teeth in one quadrant
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 |
|---|---|---|
| Brushing demonstration using T shaped toothbrushBrushing demonstration given at baseline and reinforced at 2 weeks and 1 month | Behavioural | T-shaped Toothbrush |
| Brushing demonstration using conventional toothbrushBrushing demonstration given at baseline and reinforced at 2 weeks and 1 month | Behavioural | Conventional Toothbrush |
Primary outcome
Plaque score
Time frame: 3 months
Plaque score measurement performed at baseline, after 2 weeks, 1 month and 3 months. Plaque score measurement (amount of plaque) was recorded on both the buccal and lingual sides of all teeth using the modified Quigley and Hein Plaque Index (Turesky et al., 1970) {0-no plaque present, 1- separate flecks of plaque at the cervical margin, 2- a thin, continous band of plaque at the cervical margin, 3- a band of plaque wider than 1mm but covering less than 1/3 of the surface, 4- plaque covering at least 1/3 but less than 2/3 of the surface, 5- plaque covering more than 2/3 of the surface}. Each tooth was scored in six areas: mesiofacial, midfacial, distofacial, mesiolingual, midlingual and distolingual. The minimum and maximum score per tooth was 0 and 30. The scores for each participant was summed and divided by the total number of measurements (number of teeth scored multiplied by six). Higher scores indicated worse outcome.
Gingival status
Time frame: 3 months
Gingival status measurement performed at baseline, after 2 weeks, 1 month and 3 months. Gingival status (gingival inflammation) was scored using the Loe and Silness (Loe \& Silness, 1963) {0-absence of inflammation, 1- mild inflammation, 2- moderate inflammation, 3- severe inflammation}. Each tooth was scored in six areas: mesiofacial, midfacial, distofacial, mesiolingual, midlingual and distolingual. The minimum and maximum score per tooth was 0 and 18. The scores for each participant was calculated by adding all the individual plaque scores and dividing this sum by the total number of measurements (number of teeth scored multiplied by six). Higher scores indicated worse outcome
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 21 Jun 2019.
- Derived from this study: PubMed 35392881Mamat N, Mani SA, Danaee M. T-shaped toothbrush for plaque removal and gingival health in children: a randomized controlled trial. BMC Oral Health. 2022 Apr 7;22(1):113. doi: 10.1186/s12903-022-02137-x.
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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.
Shani Ann Mani, MDS study chair
Faculty of Dentistry, University of Malaya
Questions about this trial
What is this clinical trial studying?
A study testing Brushing demonstration using T shaped toothbrush and Brushing demonstration using conventional toothbrush in people with Oral Hygiene, run by University of Malaya.
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 21 Jun 2019. 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?
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?
Plaque score (time frame: 3 months). The study lists 2 primary outcomes in all. 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 NCT03989479, which also lists 1 linked publication.
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 21 Jun 2019.