Effectiveness of Autobrush® Versus Manual Toothbrush Among Adolescents With Fixed Orthodontic Appliances

NCT07537790 | Completed

• 1 other identifier: 153-11-24
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a randomized crossover clinical trial designed to compare the effectiveness of a U-shaped automatic toothbrush (Autobrush®) versus a conventional manual toothbrush in reducing dental plaque among adolescents undergoing fixed orthodontic treatment. Each participant will be exposed to both interventions during the study period due to the crossover design. The inclusion criteria included healthy adolescents aged 12-15 years, whom were undergoing treatment with fixed orthodontic appliances attending the Orthodontic Department at KAUD Medically compromised adolescents, those with disabilities, individuals without fixed orthodontic appliances, and adolescents with known nylon allergies were excluded. Before appointment, participants were instructed to refrain from all oral hygiene measures (e.g., brushing, chewing gum) for 12 hours. On the appointment time, at the clinic, participants are assigned randomly to a toothbrush group and given disclosing solution to visualize plaque. The FMPS was recorded before brushing. Then, participants brush under supervision with their assigned toothbrush group, either manual toothbrush using Bass technique for 2 minutes or using Autobrush® with side-to-side motion for 30 seconds. After brushing, FMPS is reassessed using the same disclosing procedure. Following a washout period of at least 2 weeks, the participant repeats the procedure with the alternative toothbrush.

Conditions

Full Mouth Plaque Score (FMPS)

Keywords

Toothbrushing; Dental Plaque Index; Orthodontic Appliances; Adolescent; Oral Hygiene; Cross-Over Studies; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

• The main outcome variable is the Full Mouth Plaque Score (FMPS)

  Plaque levels were recorded on six sites per tooth (three buccal and three lingual), both before and after brushing. The FMPS difference is calculated as: FMPS difference = FMPS before brushing - FMPS after brushing This difference is expressed as a percentage: (Number of sites with plaque / Total number of sites examined) × 100

  14 days

Study Arms (2)

Group 1

EXPERIMENTAL

This is a randomized crossover clinical trial design. Participants were randomly assigned to use the Autobrush® during the first phase. After a washout period, the groups switched to a manual toothbrush.

Device: U-shaped toothbrush (Autobrush®); Device: Manual regular toothbrush

Group 2

EXPERIMENTAL

This is a randomized crossover clinical trial design. Participants were randomly assigned to use a manual toothbrush during the first phase. After a washout period, the groups switched to Autobrush® .

Device: U-shaped toothbrush (Autobrush®); Device: Manual regular toothbrush

Interventions

U-shaped toothbrush (Autobrush®) DEVICE

U-shaped toothbrush (Autobrush®) was used

Group 1; Group 2

Manual regular toothbrush DEVICE

Manual regular toothbrush

Group 1; Group 2

Eligibility Criteria

• Age: 12 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Healthy adolescents
• Aged 12-15 years
• With fixed orthodontic appliances
• Attending the Orthodontic Department at KAUD

You may not qualify if:

• Medically compromised adolescents, those with disabilities
• Individuals without fixed orthodontic appliances
• Adolescents with known nylon allergies

Sponsors & Collaborators

• Shahad Abudawood: lead
• King Abdulaziz University: collaborator

Study Sites (1)

King Abdulaziz University - Faculty of Dentistry

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: Assistent peofessor

Study Record Dates

• First Submitted: April 12, 2026
• First Posted: April 17, 2026
• Study Start: January 1, 2025
• Primary Completion: January 1, 2026
• Study Completion: March 1, 2026
• Last Updated: April 23, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1)