Effectiveness of T-shaped Toothbrush

Oral Hygiene Clinical Trial

Official title:

The Effectiveness of T-shaped Toothbrush in Plaque Removal and Maintaining Gingival Health Among Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03989479
• Other study ID #: T1
• Status: Completed
• Phase: N/A
• Start date: April 2015
• Est. completion date: January 2016

Study information

• Verified date: June 2019
• Source: University of Malaya
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: January 2016
• Est. primary completion date: September 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years to 10 Years

Eligibility

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

Related Conditions & MeSH terms

• Oral Hygiene

Intervention

Behavioral:
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Malaya

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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