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OpenTrials
Completed

NCT Number: NCT07537790

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

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.

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Key information

Age range

12 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

King Abdulaziz University - Faculty of Dentistry

Jeddah, Saudi Arabia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

U-shaped toothbrush (Autobrush®)

Device

U-shaped toothbrush (Autobrush®) was used

Manual regular toothbrush

Device

Manual regular toothbrush

Primary outcomes

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

    Time frame: 14 days

    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

Sponsors and collaborators

Lead sponsor

Shahad Abudawood

Other

Collaborators

  • King Abdulaziz University

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 17, 2026
Registry last updated
Apr 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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