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CompletedNCT03989479Updated Jun 21, 2019

Effectiveness of T-shaped Toothbrush

An interventional study of Brushing demonstration using T shaped toothbrush and Brushing demonstration using conventional toothbrush in Oral Hygiene, sponsored by University of Malaya. Completed. Open to participants aged 8 Years to 10 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-06-21.

Sponsored by University of Malaya · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 4 years 2 months after the study started (first participant enrolled Apr 2015, registered Jun 2019).
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
8 Years to 10 Years
Sex
All
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Study 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.

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.

02

Conditions studied

  • Oral Hygiene

Keywords

  • toothbrush
  • plaque removal
  • gingival health
03

In context

Lead sponsor

University of Malaya is the lead sponsor of 280 studies on the registry; 55 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
8 Years to 10 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • good systemic health
  • normal motor and cognitive development

Exclusion criteria

Exclusion Criteria:

  • 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
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Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
100 participants (actual)

Study arms

  • Active comparator
    Conventional Toothbrush

    Brushing with conventional Kid's Soft Toothbrush, Colgate (5-9-year-old)

    Behavioral: Brushing demonstration using conventional toothbrush

  • Experimental
    T-shaped Toothbrush

    Brushing with T-shaped toothbrush (Denson™, Malaysia)

    Behavioral: Brushing demonstration using T shaped toothbrush

Interventions

  • BehavioralBrushing demonstration using T shaped toothbrush

    Brushing demonstration given at baseline and reinforced at 2 weeks and 1 month

  • BehavioralBrushing demonstration using conventional toothbrush

    Brushing demonstration given at baseline and reinforced at 2 weeks and 1 month

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 3 months

  2. 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

    Time frame: 3 months

07

Study locations

No study locations are listed for this record.

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References and documents

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 documents

  • Informed consent form · Nov 26, 2014

Documents are hosted by the registry — open the source record to download them.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 21, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03989479
Lead sponsor
University of Malaya
Responsible party
Sponsor
First posted
Jun 18, 2019
Start date
Apr 2015
Primary completion
Sep 2015
Completion
Jan 2016
Last update
Jun 21, 2019

Study contacts

Shani Ann Mani, MDS
study chair · Faculty of Dentistry, University of Malaya

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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