Plaque Removal Efficacy of a U-Shaped Sonic Power Toothbrush in Children

Plaque Removal Efficacy of AutoBrush®, a 360 Degree Sonic Power Toothbrush in Children

The objective of this single-use, examiner blinded, randomized, two-period, cross-over, IRB-approved clinical study is to evaluate the safety and plaque removal efficacy of AutoBrush®, a new children's 360° sonic toothbrush, compared to a marketed children's manual toothbrush.

Study Overview

• Status: Completed
• Conditions: Dental Plaque
• Intervention / Treatment: Device: Experimental: U-shaped Power Toothbrush; Device: Placebo Comparator: Soft Manual Toothbrush

Detailed Description

Up to 22 healthy children (5-8 years old) will be enrolled in a single-center, single-use, randomized, two-period, IRB approved cross-over study. Subjects will be randomly assigned to one of two treatment sequences: 1) brush two minutes with marketed children's manual toothbrush (MTB) or 2) brush 30 seconds with AutoBrush® 360° Sonic Toothbrush (AB) and fluoride toothpaste. Qualified subjects will have pre-brushing supragingival plaque levels ≥ 1.8 according to the Lobene-Soparkar Modified Turesky Modification of the Quigley-Hein Plaque Index (PI), following 12-16 hours plaque accumulation period. Under parent's supervision, subjects brushed at home with their assigned toothbrush, twice daily during a 2-day familiarization period. After refraining (12-16 hours) from oral hygiene, subjects returned for plaque assessment, supervised use of their assigned toothbrush and a post-brushing plaque evaluation. Subjects were given the second toothbrush to begin the next 2-day familiarization period and second period evaluation procedures. Analysis of covariance (ANCOVA) will be used for single-use brushing PI models to assess whole mouth and 8 other hard-to-reach tooth sites.

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Fort Wayne, Indiana, United States, 46825
      • Salus Research, Inc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

To be eligible for study participation, subjects must meet the following criteria:

1. Generally healthy males and females at least 5-8 years of age.
2. Volunteers provide assent to participate and consent from a parent or legal guardian prior to being enrolled into the study.
3. A minimum of 12 natural teeth with scorable facial and lingual surfaces. Partially erupted permanent teeth and primary teeth that are loose or in the process of exfoliation are not included in the tooth count. Teeth that ware grossly carious, orthodontically banded, exhibiting general cervical abrasion and/or enamel abrasion ware not included in the tooth count.
4. A plaque index score ≥ 1.80 according to the Lobene-Soparkar Modification of the Turesky Modification of the Quigley-Hein Plaque Index, following 12 to 16 hours plaque accumulation

Exclusion Criteria:

Subjects presenting with any of the following will not be included in the study:

1. Having a history of adverse effects, oral soft or hard tissue sensitivity, to any ingredient in the test materials.
2. Having self-reported serious medical conditions.
3. Being under treatment for a heart condition requiring use of a pacemaker.
4. Having anything that, in the opinion of the investigator, would place the subject at increased risk or preclude the subject's full compliance with or completion of the study.
5. Having had antibiotic, anti-inflammatory, anti-coagulant medication or chemotherapeutic antiplaque/antigingivitis therapy within 30 days of screening exams.
6. Having participated in any study involving oral care products, concurrently or within the 30 days of screening exams.
7. Presence of severe periodontal disease or being actively treated for periodontal disease.
8. Having grossly carious, fully crowned, or extensively restored teeth.
9. Having orthodontic appliances, peri/oral piercings, or removable partial dentures.
10. Having significant oral soft tissue pathology based on a visual examination.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AutoBrush U-shaped power toothbrush, then Manual Toothbrush; Participants first received the AutoBrush U-shaped power toothbrush with fluoride toothpaste for a single brushing use for 30 seconds; after a 2-day washout period, participants received the ADA reference manual toothbrush for a single brushing use for 2 minutes.	Device: Experimental: U-shaped Power Toothbrush; Twice daily brushing for 30 seconds with fluoride toothpaste; Device: Placebo Comparator: Soft Manual Toothbrush; Twice daily brushing for 2 minutes with fluoride toothpaste
Experimental: Manual Toothbrush; Participants first received the ADA reference manual toothbrush for a single brushing use for 2 minutes; after a 2-day washout period, participants received the AutoBrush U-shaped power toothbrush with fluoride toothpaste for a single brushing use for 30 seconds.	Device: Experimental: U-shaped Power Toothbrush; Twice daily brushing for 30 seconds with fluoride toothpaste; Device: Placebo Comparator: Soft Manual Toothbrush; Twice daily brushing for 2 minutes with fluoride toothpaste

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Within-Treatment Whole-Mouth Differences (vs Baseline) - Plaque removal Mean Change from baseline (pre-brushing to post-brushing) in plaque score after single supervised use based on all tooth surfaces of the whole mouth.	Supragingival dental plaque: Lobene-Soparkar Modification of Turesky Modification of Quigley-Hein Plaque Index Plaque will be disclosed using a red disclosing solution and each tooth will be scored in six areas (disto-buccal, mid-buccal and mesio-buccal, disto-lingual, mid-lingual and mesio-lingual), according to the criteria noted below: 0 = No plaque.; = Separate flecks or discontinuous band of plaque at the gingival (cervical) margin.; = Thin (up to 1 mm), continuous band of plaque at the gingival margin.; = Band of plaque wider than 1 mm but less than 1/3 of tooth surface area.; = Plaque covering 1/3 or more, but less than 2/3 of tooth surface area.; = Plaque covering 2/3 or more of tooth surface area.	Up to 2 weeks

Collaborators and Investigators

• Sponsor: Lander Enterprises, LLC

Study record dates

Study Major Dates

• Study Start (Actual): February 14, 2023
• Primary Completion (Actual): February 17, 2023
• Study Completion (Actual): February 17, 2023

Study Registration Dates

• First Submitted: February 29, 2024
• First Submitted That Met QC Criteria: March 5, 2024
• First Posted (Actual): March 8, 2024

Study Record Updates

• Last Update Posted (Actual): March 8, 2024
• Last Update Submitted That Met QC Criteria: March 5, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: gingivitis; toothbrush
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Dental Deposits; Dental Plaque
• Other Study ID Numbers: AB-360-001-2022

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No