Effectiveness of T-shaped Toothbrush

NCT03989479 | Completed DMC

• 1 other identifier: T1
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief 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

Conditions

Oral Hygiene

Keywords

toothbrush; plaque removal; gingival health

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Conventional Toothbrush

ACTIVE COMPARATOR

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

Behavioral: Brushing demonstration using conventional toothbrush

T-shaped Toothbrush

EXPERIMENTAL

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

Behavioral: Brushing demonstration using T shaped toothbrush

Interventions

Brushing demonstration using T shaped toothbrush BEHAVIORAL

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

T-shaped Toothbrush

Brushing demonstration using conventional toothbrush BEHAVIORAL

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

Conventional Toothbrush

Eligibility Criteria

• Age: 8 Years - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• good systemic health
• normal motor and cognitive development

You may not qualify if:

• acute intraoral lesion
• history of antibiotic and/ or antiseptic therapy in the past one month
• interproximal caries or restorations
• or more missing teeth in one quadrant

Sponsors & Collaborators

• University of Malaya: lead

Related Publications (1)

• 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.

  PMID: 35392881 DERIVED

Study Officials

• Shani Ann Mani, MDS

  Faculty of Dentistry, University of Malaya

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2019
• First Posted: June 18, 2019
• Study Start: April 1, 2015
• Primary Completion: September 1, 2015
• Study Completion: January 1, 2016
• Last Updated: June 21, 2019

Record last verified: 2019-06