NCT07537803

Brief Summary

Demographic information were collected from the participants. Assigned the participant to the intervention group. Participants were instructed to avoid all kinds of oral cleaning procedures approximately 12 hours before their appointments. To assess the Full Mouth Plaque Score using a disclosing tablet. participants were assigned to the Autobrush (U-shaped toothbrush) (Manual bundle with double-sided nylon brush head U-shaped fits 9-12 Years, San Diego, California). First: Manual regular toothbrush (R): Modified Bass Technique for the mixed dentition was used. Second: Autobrush U-shaped Toothbrush (U) was used. Subsequently, the examiner conducted a second FMPS examination.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 21, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 27, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 27, 2024

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

April 12, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 17, 2026

Completed
Last Updated

April 23, 2026

Status Verified

April 1, 2026

Enrollment Period

1 month

First QC Date

April 12, 2026

Last Update Submit

April 20, 2026

Conditions

Full Mouth Plaque Score (FMPS)

Keywords

ToothbrushingDental Plaque IndexOral HygieneRandomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

  • Full Mouth Plaque Score

    Full Mouth Plaque Score (FMPS) was used to assess dental plaque accumulation, with scores ranging from 0% to 100%, where higher scores indicate greater plaque accumulation and therefore a worse oral hygiene outcome.

    At "Day 1" and "Day 14"

Study Arms (2)

Manual regular toothbrush

EXPERIMENTAL
Device: Manual regular toothbrush

Autobrush U-shaped Toothbrush

EXPERIMENTAL
Device: Autobrush U-shaped Toothbrush

Interventions

Autobrush U-shaped ToothbrushDEVICE

Autobrush U-shaped Toothbrush

Autobrush U-shaped Toothbrush
Manual regular toothbrushDEVICE

Manual regular toothbrush

Manual regular toothbrush

Eligibility Criteria

Age9 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Healthy children
  • Aged 9 to 12 years old
  • Does not have fixed orthodontic treatment
  • With Full Mouth Plaque Score (FMPS) of 30% or higher.

You may not qualify if:

  • Children with disabilities
  • Children with oral appliances
  • Children with nylon allergy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

King Abdulaziz University

Jeddah, Saudi Arabia

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assisstant Professor

Study Record Dates

First Submitted

April 12, 2026

First Posted

April 17, 2026

Study Start

December 21, 2023

Primary Completion

January 27, 2024

Study Completion

January 27, 2024

Last Updated

April 23, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Patient privacy

Locations

SA(1)