Effectiveness of T-shaped Toothbrush

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

Study Overview

• Status: Completed
• Conditions: Oral Hygiene
• Intervention / Treatment: Behavioral: Brushing demonstration using conventional toothbrush; Behavioral: Brushing demonstration using T shaped toothbrush

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 Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 10 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• good systemic health
• normal motor and cognitive development

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Conventional Toothbrush; Brushing with conventional Kid's Soft Toothbrush, Colgate (5-9-year-old)	Behavioral: Brushing demonstration using conventional toothbrush; Brushing demonstration given at baseline and reinforced at 2 weeks and 1 month
Experimental: T-shaped Toothbrush; Brushing with T-shaped toothbrush (Denson™, Malaysia)	Behavioral: Brushing demonstration using T shaped toothbrush; Brushing demonstration given at baseline and reinforced at 2 weeks and 1 month

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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	3 months

Collaborators and Investigators

• Sponsor: University of Malaya
• Investigators: Study Chair: Shani Ann Mani, MDS, Faculty of Dentistry, University of Malaya

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2015
• Primary Completion (Actual): September 1, 2015
• Study Completion (Actual): January 1, 2016

Study Registration Dates

• First Submitted: June 13, 2019
• First Submitted That Met QC Criteria: June 13, 2019
• First Posted (Actual): June 18, 2019

Study Record Updates

• Last Update Posted (Actual): June 21, 2019
• Last Update Submitted That Met QC Criteria: June 19, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Keywords: toothbrush; plaque removal; gingival health
• Other Study ID Numbers: T1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No