U Shaped Toothbrush in Removing Plaque in Children

NCT06288581 | Completed

• 1 other identifier: UDDS-Pedo-02-2024
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to evaluate the effectiveness of a U-shaped toothbrush in removing plaque in preschool children which can be a simple, acceptable, and effective way to remove plaque in children in order to improve their oral health in the absence of parental supervision. Children accepted in the study will be randomly divided into two groups: The traditional toothbrush group and the U-shaped toothbrush group, All children aged four to five years will have their plaque assessed with the Turesky Modified Quigley Hein Index (TMQH)

Conditions

Dental Plaque

Keywords

U shaped toothbrush; Traditional toothbrush; Plaque removal; Oral hygiene; Pre-schooled children

Outcome Measures

Primary Outcomes (1)

• Changing in plaque index

  0 No plaque,1 Isolated flecks of plaque at the gingival margin, 2 A continuous band of plaque up to 1mm at the gingival margin, 3 Plaque greater than 1mm in width and covering up to one third of the tooth surface, 4 Plaque covering from one thirds to two thirds of the tooth surface, and 5 Plaque covering more than two thirds of the tooth surface

  Plaque index will be measured before brushing (T0) and after brushing in both groups on the first day (T1), a week after use (T2), and after a month of use (T3) with each toothbrush

Study Arms (2)

Traditional toothbrush group

EXPERIMENTAL

Children in this group will use a traditional brush first to clean their teeth then will use U shaped brush later.

Other: Traditional toothbrush group

U shaped toothbrush group

EXPERIMENTAL

children in this group will use a U-shaped brush first to clean their teeth then will use traditional brush later

Other: U shaped toothbrush group

Interventions

Traditional toothbrush group OTHER

Children in this group will use a traditional brush with a traditional toothpaste first to clean their teeth then after 30 days they will use a U shaped brush with a traditional toothpaste for another 30 days.

Traditional toothbrush group

U shaped toothbrush group OTHER

Children in this group will use a U shaped brush with a traditional toothpaste first to clean their teeth then after 30 days they will use a traditional brush with a traditional toothpaste for another 30 days.

U shaped toothbrush group

Eligibility Criteria

• Age: 4 Years - 5 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Medically free children. Complete temporary occlusion (no missing temporary teeth). The parents' approval for the child to enter the study.

You may not qualify if:

• Children with limited ability to communicate. Children with motor disabilities.

Sponsors & Collaborators

• Damascus University: lead

Study Sites (1)

Damascus University

Damascus, 20872, Syria

Location

MeSH Terms

Conditions

Dental Plaque

Condition Hierarchy (Ancestors)

Dental Deposits; Tooth Diseases; Stomatognathic Diseases

Study Design

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

Study Record Dates

• First Submitted: February 25, 2024
• First Posted: March 1, 2024
• Study Start: February 1, 2024
• Primary Completion: May 1, 2024
• Study Completion: August 15, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

SY (1)