Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
100 participants
INTERVENTIONAL
2015-04-30
2016-01-31
Brief Summary
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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
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Conventional Toothbrush
Brushing with conventional Kid's Soft Toothbrush, Colgate (5-9-year-old)
Brushing demonstration using conventional toothbrush
Brushing demonstration given at baseline and reinforced at 2 weeks and 1 month
T-shaped Toothbrush
Brushing with T-shaped toothbrush (Denson™, Malaysia)
Brushing demonstration using T shaped toothbrush
Brushing demonstration given at baseline and reinforced at 2 weeks and 1 month
Interventions
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Brushing demonstration using T shaped toothbrush
Brushing demonstration given at baseline and reinforced at 2 weeks and 1 month
Brushing demonstration using conventional toothbrush
Brushing demonstration given at baseline and reinforced at 2 weeks and 1 month
Eligibility Criteria
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Inclusion Criteria
* normal motor and cognitive development
Exclusion Criteria
* history of antibiotic and/ or antiseptic therapy in the past one month
* interproximal caries or restorations
* 3 or more missing teeth in one quadrant
8 Years
10 Years
ALL
Yes
Sponsors
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University of Malaya
OTHER
Responsible Party
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Principal Investigators
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Shani Ann Mani, MDS
Role: STUDY_CHAIR
Faculty of Dentistry, University of Malaya
References
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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.
Provided Documents
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Document Type: Informed Consent Form
Other Identifiers
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T1
Identifier Type: -
Identifier Source: org_study_id
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