Dental Plaque AccumulationNCT07810868
Effectiveness of Ortho-Buddy on Plaque Control in Orthodontic Patients
A study testing Standard Toothbrush and Ortho-Buddy in people with Dental Plaque Accumulation, run by Rutgers, The State University of New Jersey at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 11 to 18 years
- Conditions the study is for
- Dental Plaque Accumulation
- What is being tested?
- Standard Toothbrush and Ortho-Buddy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 18 May 2022to 4 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- Pregnancy
- Current chronic antibiotic therapy or antibiotic use within one month before the study
- Chronic NSAID use
- Chronic steroid use
Trial locations and contacts
1 site in 1 country.
United States1 site
Rutgers School of Dental Medicine
Newark, New Jersey, 07103
About this study
Official title: Evaluate and Compare the Effectiveness of a Novel Toothbrush, Ortho-Buddy, Designed Specifically for Patients Undergoing Orthodontic Treatment With a Standard Toothbrush
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?
Read more
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.
Read the 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.
- Conditions
- Dental Plaque Accumulation
- Being tested
- Standard Toothbrush, Ortho-Buddy
- Keywords
- Orthodontics, Fixed Orthodontic Appliances, Oral Hygiene, Dental Plaque, Ortho-Buddy
- Medical subject headings
- Dental Plaque
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard ToothbrushDevice
A conventional manual toothbrush used for supervised brushing according to the assigned study protocol.
Ortho-BuddyDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Standard Toothbrush Only | Active comparator | Participants brushed for 2 minutes with a standard toothbrush, with 1 minute of brushing per arch. Receives: Device: Standard Toothbrush |
| Standard Toothbrush + Ortho-Buddy | Experimental | Participants brushed with a standard toothbrush for 1 minute (30 seconds per arch), followed by the Ortho-Buddy brush for 1 minute (30 seconds per arch). Receives: Device: Standard Toothbrush; Device: Ortho-Buddy |
| Ortho-Buddy Only | Experimental | Participants brushed for 2 minutes with the Ortho-Buddy brush, with 1 minute of brushing per arch. Receives: Device: Ortho-Buddy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Dental Plaque Using the Turesky Modification of the Quigley-Hein Plaque Index
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.
Measured: Immediately before and immediately after the 2-minute brushing intervention during a single study visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2026
- Study start18 May 2022
- Primary completion4 Nov 2024
- Study completion4 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental Plaque AccumulationStudies of the same condition, open and under way.
- More trials run by Rutgers, The State University of New JerseyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Collaborators
- Ortho-Buddy, Inc
- Responsible party
- Principal investigator, Anil Ardeshna, BDS, DMD, MSD, Rutgers, The State University of New Jersey
- Investigators
- Anil Ardeshna, BDS, DMD, MSD, Principal investigator, Rutgers School of Dental Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07810868
- Sponsor's protocol ID
- Pro2021002077
- Status last verified
- Sep 2026
- First submitted
- 2 Sep 2026
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared because no formal data-sharing plan was established for this study.
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluate and Compare the Effectiveness of a Novel Toothbrush, Ortho-Buddy, Designed Specifically for Patients Undergoing Orthodontic Treatment With a Standard Toothbrush
- ClinicalTrials.gov ID
- NCT07810868
- Acronym / sponsor ID
- Pro2021002077
- Conditions
- Dental Plaque Accumulation
- Keywords
- Orthodontics, Fixed Orthodontic Appliances, Oral Hygiene, Dental Plaque, Ortho-Buddy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Collaborators
- Ortho-Buddy, Inc
- Study start
- 18 May 2022 (actual)
- Primary completion
- 4 Nov 2024 (actual)
- Study completion
- 4 Nov 2024 (actual)
- First posted
- 9 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standard Toothbrush Only | Active comparator | Device: Standard ToothbrushParticipants brushed for 2 minutes with a standard toothbrush, with 1 minute of brushing per arch. |
| Standard Toothbrush + Ortho-Buddy | Experimental | Device: Standard Toothbrush, Device: Ortho-BuddyParticipants brushed with a standard toothbrush for 1 minute (30 seconds per arch), followed by the Ortho-Buddy brush for 1 minute (30 seconds per arch). |
| Ortho-Buddy Only | Experimental | Device: Ortho-BuddyParticipants brushed for 2 minutes with the Ortho-Buddy brush, with 1 minute of brushing per arch. |
Who may qualify
- Ages
- 11 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard ToothbrushA conventional manual toothbrush used for supervised brushing according to the assigned study protocol. | Device | Standard Toothbrush + Ortho-Buddy, Standard Toothbrush Only |
| Ortho-BuddyA 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. | Device | Ortho-Buddy Only, Standard Toothbrush + Ortho-Buddy |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared because no formal data-sharing plan was established for this study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anil Ardeshna, BDS, DMD, MSD principal investigator
Rutgers School of Dental Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard Toothbrush and Ortho-Buddy in people with Dental Plaque Accumulation, run by Rutgers, The State University of New Jersey at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2026.