U Shaped Toothbrush in Removing Plaque in Children

Dental Plaque Clinical Trial

Official title:

Evaluating the Effectiveness of a U-shaped Toothbrush in Removing Plaque In Pre-school Children

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06288581
• Other study ID #: UDDS-Pedo-02-2024
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 1, 2024
• Est. completion date: August 1, 2024

Study information

• Verified date: May 2024
• Source: Damascus University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Description:

This study will evaluate the effectiveness U-shaped toothbrush in removing plaque and improving oral health. Children were randomly assigned to one of the following groups:

Group A: children in this group will use a traditional brush first to clean their teeth then will use U shaped brush later.

Group B: children in this group will use a U-shaped brush first to clean their teeth then will use a traditional brush later The plaque will be assessed by a blinded evaluator using the Turesky Modified Quigley Hein index (TMQH) in both groups at 4 different times(T0): before brush (T1): after brush (T2): a week after use (T3): a month of use The toothbrush will be changed after one month of use.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: August 1, 2024
• Est. primary completion date: May 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Years to 5 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Dental Plaque

Intervention

Other:
• Traditional toothbrush group
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.
• U shaped toothbrush group
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.

Locations

Country	Name	City	State
Syrian Arab Republic	Damascus University	Damascus

Sponsors (1)

Lead Sponsor	Collaborator
Damascus University

Country where clinical trial is conducted

Syrian Arab Republic, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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