Rutgers School of Dental Medicine
Newark, New Jersey, 07103, United States
NCT Number: NCT07810868
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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Notify Me11 year–18 year
All sexes
Interventional
Not applicable
Newark, New Jersey, 07103, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
A conventional manual toothbrush used for supervised brushing according to the assigned study protocol.
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.
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.
Rutgers, The State University of New Jersey
Other
Evaluate and Compare the Effectiveness of a Novel Toothbrush, Ortho-Buddy, Designed Specifically for Patients Undergoing Orthodontic Treatment With a Standard Toothbrush
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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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