Effectiveness of Ortho-Buddy on Plaque Control in Orthodontic Patients

NCT07810868 | Completed

• 1 other identifier: Pro2021002077
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Dental Plaque Accumulation

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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.

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

Study Arms (3)

Standard Toothbrush Only

ACTIVE COMPARATOR

Participants brushed for 2 minutes with a standard toothbrush, with 1 minute of brushing per arch.

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).

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.

Device: Ortho-Buddy

Interventions

Standard Toothbrush DEVICE

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

Standard Toothbrush + Ortho-Buddy; Standard Toothbrush Only

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.

Ortho-Buddy Only; Standard Toothbrush + Ortho-Buddy

Eligibility Criteria

• Age: 11 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead
• Ortho-Buddy, Inc: collaborator

Study Sites (1)

Rutgers School of Dental Medicine

Newark, New Jersey, 07103, United States

Location

MeSH Terms

Conditions

Dental Plaque

Condition Hierarchy (Ancestors)

Dental Deposits; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Anil Ardeshna, BDS, DMD, MSD

  Rutgers School of Dental Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Department of Orthodontics, Rutgers School of Dental Medicine

Study Record Dates

• First Submitted: September 2, 2026
• First Posted: September 9, 2026
• Study Start: May 18, 2022
• Primary Completion: November 4, 2024
• Study Completion: November 4, 2024
• Last Updated: September 14, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)