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Completed

NCT Number: NCT07810868

Effectiveness of Ortho-Buddy on Plaque Control in Orthodontic Patients

The goal of this clinical trial is to learn whether the Ortho-Buddy toothbrush can improve plaque removal in adolescents undergoing orthodontic treatment with fixed appliances. The main question it aims to answer is:

Does using the Ortho-Buddy toothbrush, alone or together with a standard toothbrush, reduce dental plaque more effectively than using a standard toothbrush alone?

Researchers compared three brushing methods to see which was most effective for plaque removal.

Participants:

* Had dental plaque disclosed and measured before brushing * Brushed for 2 minutes using either a standard toothbrush, the Ortho-Buddy toothbrush, or a combination of both * Had dental plaque measured again immediately after brushing.

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Key information

Age range

11 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rutgers School of Dental Medicine

Newark, New Jersey, 07103, United States

About this study

The Ortho-Buddy is a toothbrush adjunct designed to help clean around fixed orthodontic appliances, where plaque accumulation can be difficult to control with a conventional toothbrush alone. This randomized clinical trial compared the immediate plaque-removal effectiveness of three supervised brushing approaches in orthodontic patients with fixed appliances.

Participants were assigned to one of three groups: standard toothbrush alone, standard toothbrush followed by Ortho-Buddy, or Ortho-Buddy alone. Dental plaque was disclosed and scored before brushing and again immediately after a 2-minute supervised brushing session using the assigned method.

Plaque was assessed using the Turesky modification of the Quigley-Hein Plaque Index. The study was conducted at the Rutgers School of Dental Medicine orthodontic clinic during a single study visit.

That gives useful context without repeating the exact outcome measures or arm descriptions that you will enter elsewhere. Your IRB describes the study as a one-visit pilot evaluating Ortho-Buddy for oral hygiene in patients with fixed orthodontic appliances.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Full complement of permanent teeth from first molar to first molar
  • Presence of full fixed orthodontic appliances on both arches for at least two weeks
  • Patients who had undergone premolar extractions for orthodontic purposes were eligible

Exclusion criteria

  • Poor systemic health
  • Professional dental cleaning or scaling within two weeks before the study
  • Documented poor oral hygiene
  • History of tobacco use
  • Presence of a heart murmur
  • History of rheumatic fever
  • Pregnancy
  • Current chronic antibiotic therapy or antibiotic use within one month before the study
  • Chronic NSAID use
  • Chronic steroid use

Treatment and study plan

Standard Toothbrush

Device

A conventional manual toothbrush used for supervised brushing according to the assigned study protocol.

Ortho-Buddy

Device

A toothbrush adjunct designed for cleaning around fixed orthodontic appliances. The device consists of a wire with nylon fibers arranged in a cylindrical configuration to facilitate cleaning around orthodontic brackets and archwires. Participants received standardized instructions for its use.

Primary outcomes

  1. Change in Dental Plaque Using the Turesky Modification of the Quigley-Hein Plaque Index

    Time frame: Immediately before and immediately after the 2-minute brushing intervention during a single study visit

    Dental plaque was disclosed and scored using the Turesky modification of the Quigley-Hein Plaque Index. The mesial, middle, and distal facial/buccal surfaces were scored from 0 to 5, where 0 indicated no plaque and 5 indicated plaque covering more than two-thirds of the tooth surface. Plaque scores were recorded before and immediately after the assigned 2-minute brushing intervention. The primary analysis compared the percentage change in plaque scores among the three intervention groups.

Sponsors and collaborators

Lead sponsor

Rutgers, The State University of New Jersey

Other

Collaborators

  • Ortho-Buddy, Inc

Registry information

Official study title

Evaluate and Compare the Effectiveness of a Novel Toothbrush, Ortho-Buddy, Designed Specifically for Patients Undergoing Orthodontic Treatment With a Standard Toothbrush

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Sep 9, 2026
Registry last updated
Sep 9, 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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