## Protocol Section
### Identification Module
**NCT ID:** NCT03989479

**Brief Title:** Effectiveness of T-shaped Toothbrush

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

#### Organization Study ID Info
**ID:** T1
#### Organization
**Class:** OTHER
**Full Name:** University of Malaya
### Status Module
#### Completion Date
**Date:** 2016-01

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2019-06-21

**Type:** ACTUAL

**Last Update Submit Date:** 2019-06-19

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2015-09

**Type:** ACTUAL

#### Start Date
**Date:** 2015-04

**Type:** ACTUAL

**Status Verified Date:** 2019-06

#### Study First Post Date
**Date:** 2019-06-18
**Type:** ACTUAL
**Study First Submit Date:** 2019-06-13
**Study First Submit QC Date:** 2019-06-13
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** University of Malaya

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**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

**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.

### Conditions Module

**Conditions:**

- Oral Hygiene

**Keywords:**

- toothbrush

- plaque removal

- gingival health

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** SINGLE

**Who Masked:**

- INVESTIGATOR

**Primary Purpose:** PREVENTION

#### Enrollment Info

**Count:** 100

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

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

**Intervention Names:**

- Behavioral: Brushing demonstration using conventional toothbrush

**Label:** Conventional Toothbrush

**Type:** ACTIVE_COMPARATOR

#### Arm Group 2

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

**Intervention Names:**

- Behavioral: Brushing demonstration using T shaped toothbrush

**Label:** T-shaped Toothbrush

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- T-shaped Toothbrush

**Description:** Brushing demonstration given at baseline and reinforced at 2 weeks and 1 month

**Name:** Brushing demonstration using T shaped toothbrush

**Type:** BEHAVIORAL

#### Intervention 2

**Arm Group Labels:**

- Conventional Toothbrush

**Description:** Brushing demonstration given at baseline and reinforced at 2 weeks and 1 month

**Name:** Brushing demonstration using conventional toothbrush

**Type:** BEHAVIORAL

### Outcomes Module

#### Primary Outcomes

**Description:** 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.

**Measure:** Plaque score

**Time Frame:** 3 months

**Description:** 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

**Measure:** Gingival status

**Time Frame:** 3 months

### Eligibility Module

**Eligibility Criteria:** 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

**Healthy Volunteers:** True

**Maximum Age:** 10 Years

**Minimum Age:** 8 Years

**Sex:** ALL

**Standard Ages:**

- CHILD

### Contacts Locations Module

#### Overall Officials

**Official 1:**

**Affiliation:** Faculty of Dentistry, University of Malaya

**Name:** Shani Ann Mani, MDS

**Role:** STUDY_CHAIR

### References Module

#### References

**Citation:** 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

## Document Section

### Large Document Module

#### Large Docs

- Date: 2014-11-26

- Filename: ICF_000.pdf

- Has ICF: True

- Has Protocol: False

- Has SAP: False

- Label: Informed Consent Form

- Size: 263270

- Type Abbrev: ICF

- Upload Date: 2019-06-11T00:52

## Derived Section

### Intervention Browse Module - Browse Branches

- Abbrev: Infe

- Name: Anti-Infective Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M140080

- Name: Listerine

- Relevance: LOW

- As Found: Unknown

- ID: M15771

- Name: Sodium Fluoride

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24
