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Effectiveness of Ortho-Buddy on Plaque Control in Orthodontic Patients

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07810868
Enrollment
48
Registered
2026-09-09
Start date
2022-05-18
Completion date
2024-11-04
Last updated
2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dental Plaque Accumulation

Keywords

Orthodontics, Fixed Orthodontic Appliances, Oral Hygiene, Dental Plaque, Ortho-Buddy

Brief summary

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.

Detailed description

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.

Interventions

DEVICEStandard Toothbrush

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

DEVICEOrtho-Buddy

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.

Sponsors

Rutgers, The State University of New Jersey
Lead SponsorOTHER
Ortho-Buddy, Inc
CollaboratorUNKNOWN

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
11 Years to 18 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in Dental Plaque Using the Turesky Modification of the Quigley-Hein Plaque IndexImmediately before and immediately after the 2-minute brushing intervention during a single study visitDental 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.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORAnil Ardeshna, BDS, DMD, MSD

Rutgers School of Dental Medicine

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 15, 2026