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

NCT ID: NCT06300073

Last Updated: 2024-03-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-14
• Study Completion Date: 2023-02-17

Brief Summary

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.

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.

Conditions

Dental Plaque

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Experimental: U-shaped Power Toothbrush

Intervention Type: DEVICE

Twice daily brushing for 30 seconds with fluoride toothpaste

Placebo Comparator: Soft Manual Toothbrush

Intervention Type: DEVICE

Twice daily brushing for 2 minutes with fluoride toothpaste

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.

Group Type: EXPERIMENTAL

Experimental: U-shaped Power Toothbrush

Intervention Type: DEVICE

Twice daily brushing for 30 seconds with fluoride toothpaste

Placebo Comparator: Soft Manual Toothbrush

Intervention Type: DEVICE

Twice daily brushing for 2 minutes with fluoride toothpaste

Interventions

Experimental: U-shaped Power Toothbrush

Twice daily brushing for 30 seconds with fluoride toothpaste

Intervention Type: DEVICE

Placebo Comparator: Soft Manual Toothbrush

Twice daily brushing for 2 minutes with fluoride toothpaste

Intervention Type: DEVICE

Eligibility Criteria

Inclusion 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.

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 8 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Lander Enterprises, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Salus Research, Inc

Fort Wayne, Indiana, United States

Countries

United States

Other Identifiers

AB-360-001-2022

Identifier Type: -

Identifier Source: org_study_id