Effectiveness of T-shaped Toothbrush

NCT ID: NCT03989479

Last Updated: 2019-06-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-30

Study Completion Date

2016-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Oral Hygiene

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Conventional Toothbrush

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

Group Type ACTIVE_COMPARATOR

Brushing demonstration using conventional toothbrush

Intervention Type BEHAVIORAL

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

T-shaped Toothbrush

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

Group Type EXPERIMENTAL

Brushing demonstration using T shaped toothbrush

Intervention Type BEHAVIORAL

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Brushing demonstration using T shaped toothbrush

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

Intervention Type BEHAVIORAL

Brushing demonstration using conventional toothbrush

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

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

8 Years

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Malaya

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Shani Ann Mani, MDS

Role: STUDY_CHAIR

Faculty of Dentistry, University of Malaya

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 35392881 (View on PubMed)

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Informed Consent Form

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

T1

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.