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

NCT06300073 | Completed

• 1 other identifier: AB-360-001-2022
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Dental Plaque

Keywords

gingivitis; toothbrush

Outcome Measures

Primary Outcomes (1)

• 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. 1. = Separate flecks or discontinuous band of plaque at the gingival (cervical) margin. 2. = Thin (up to 1 mm), continuous band of plaque at the gingival margin. 3. = Band of plaque wider than 1 mm but less than 1/3 of tooth surface area. 4. = Plaque covering 1/3 or more, but less than 2/3 of tooth surface area. 5. = Plaque covering 2/3 or more of tooth surface area.

  Up to 2 weeks

Study Arms (2)

AutoBrush U-shaped power toothbrush, then Manual Toothbrush

EXPERIMENTAL

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; Device: Placebo Comparator: Soft Manual Toothbrush

Manual Toothbrush

EXPERIMENTAL

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; Device: Placebo Comparator: Soft Manual Toothbrush

Interventions

Experimental: U-shaped Power Toothbrush DEVICE

Twice daily brushing for 30 seconds with fluoride toothpaste

AutoBrush U-shaped power toothbrush, then Manual Toothbrush; Manual Toothbrush

Placebo Comparator: Soft Manual Toothbrush DEVICE

Twice daily brushing for 2 minutes with fluoride toothpaste

AutoBrush U-shaped power toothbrush, then Manual Toothbrush; Manual Toothbrush

Eligibility Criteria

• Age: 5 Years - 8 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may not qualify if:

• Subjects presenting with any of the following will not be included in the study:
• Having a history of adverse effects, oral soft or hard tissue sensitivity, to any ingredient in the test materials.
• Having self-reported serious medical conditions.
• Being under treatment for a heart condition requiring use of a pacemaker.
• 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.
• Having had antibiotic, anti-inflammatory, anti-coagulant medication or chemotherapeutic antiplaque/antigingivitis therapy within 30 days of screening exams.
• Having participated in any study involving oral care products, concurrently or within the 30 days of screening exams.
• Presence of severe periodontal disease or being actively treated for periodontal disease.
• Having grossly carious, fully crowned, or extensively restored teeth.
• Having orthodontic appliances, peri/oral piercings, or removable partial dentures.
• Having significant oral soft tissue pathology based on a visual examination.

Sponsors & Collaborators

• Lander Enterprises, LLC: lead

Study Sites (1)

Salus Research, Inc

Fort Wayne, Indiana, 46825, United States

Location

MeSH Terms

Conditions

Dental Plaque; Gingivitis

Condition Hierarchy (Ancestors)

Dental Deposits; Tooth Diseases; Stomatognathic Diseases; Infections; Gingival Diseases; Periodontal Diseases; Mouth Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Examiner and data recorder will not have access to the room for test materials dispensing and instructions.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: single-use, randomized, two-period, cross-over study

Study Record Dates

• First Submitted: February 29, 2024
• First Posted: March 8, 2024
• Study Start: February 14, 2023
• Primary Completion: February 17, 2023
• Study Completion: February 17, 2023
• Last Updated: March 8, 2024

Record last verified: 2024-03

Locations

US (1)