Safety and Efficacy of U-Shaped Sonic Toothbrush on Plaque and Gingivitis

NCT06126250 | Completed

• 1 other identifier: AB-GBP-2023-03
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this 30 day, randomized, two group, parallel, examiner-blind clinical study is to evaluate the safety and efficacy of AutoBrush® 360° U-shaped Sonic Toothbrush on supragingival dental plaque and gingivitis, compared to an American Dental Association (ADA) reference manual soft toothbrush. The extent of gingival abrasion and recession and oral safety will be evaluated.

Conditions

Plaque Induced Gingivitis

Outcome Measures

Primary Outcomes (2)

• Gingivitis: Modified Gingival Index (MGI)

  Gingival Inflammation, assessed on a 5-point scale (0 to 4), will be scored in six areas (disto-buccal, mid-buccal and mesio-buccal, disto-lingual, mid-lingual and mesio-lingual) of all scorable teeth using criteria: 0 = Normal (absence of inflammation), 1 = Mild inflammation (slight change in color, little change in texture) of any portion of the entire gingival unit; 2 = Mild inflammation of the entire gingival unit; 3 = Moderate inflammation (moderate glazing, redness, edema, and/or hypertrophy) of the gingival unit; 4 = Severe inflammation (marked redness and edema/hypertrophy, spontaneous bleeding, or ulceration) of the gingival unit.

  Whole mouth mean change in MGI scores at Day 30.

• Plaque: Lobene-Soparkar Modification of Turesky Modification of Quigley-Hein Plaque Index (LSPI)

  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.

  Whole mouth mean change in LSPI scores at Day 30, immediate post-brushing (Pre- to Post-Brushing scores)

Secondary Outcomes (4)

• Gingivitis

  Change from Baseline at Day 15 and Day 30]

• Plaque

  Change from Baseline at Day 15 and Day 30

• Safety: gingival recession

  Changes from Baseline at Day 15 and Day 30

• Safety: gingival abrasion

  Changes from Baseline at Day 15 and Day 30

Study Arms (2)

U-shaped power toothbrush

EXPERIMENTAL

Device: U-shaped Power Toothbrush with fluoride toothpaste

Device: Power sonic toothbrush

Manual Toothbrush

PLACEBO COMPARATOR

Device: Soft Manual Toothbrush with fluoride toothpaste

Device: Manual toothbrush

Interventions

Power sonic toothbrush DEVICE

Subjects will brush twice daily for 30 seconds using a fluoride toothpaste.

Also known as: AutoBrush 360 U-Shaped power toothbrush

U-shaped power toothbrush

Manual toothbrush DEVICE

Subjects will brush twice daily for 2 minutes using a fluoride toothpaste.

Also known as: ADA Reference standard soft manual toothbrush

Manual Toothbrush

Eligibility Criteria

• Age: 5 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• generally healthy males and females at least 5 to 65 years of age.
• If under age 18, willing to provide assent to participate and consent from a parent or legal guardian prior to being entered into the study; If 18 years of age or older, is able to read, sign and receive a copy of the signed informed consent form.
• regular manual toothbrush users and able to brush their own teeth on a daily basis.
• In good health based on medical history review by the investigator.
• willing to refrain from all oral hygiene for approximately 12-16 hours prior to each study visit and discontinue eating and drinking for approximately 30 minutes prior to each study visit, with the exception of sips of water.
• Have a minimum of 18 natural teeth, in the adult dentition, with scorable facial and lingual surfaces. If under the age of 12, must have at least 12 fully erupted teeth, primary or permanent teeth. Partially erupted permanent teeth and primary teeth that are loose or in process of exfoliation will not be included in the tooth count. Teeth that are grossly carious, orthodontically banded, exhibiting general cervical abrasion and/or enamel abrasion, \> 2 mm gingival recession will not be included in the tooth count.
• Present with a gingival index score ≥ 1.75 according to the Modified Gingival Index at Baseline, a plaque index score \> 1.80 according to the Lobene-Soparkar Modification of the Turesky Modification of the Quigley-Hein Plaque Index, following a 12 to 16-hour plaque accumulation period at Baseline.
• willing and able to refrain from dental treatment during the course of the study, except on an emergency basis.

You may not qualify if:

• history of adverse effects, oral soft or hard tissue sensitivity, to any ingredient in the test materials.
• Self-reported serious medical conditions.
• Self-reported as pregnant or nursing.
• Under treatment for a heart condition requiring use of pacemaker.
• Have any condition, in the opinion of the investigator, that would place the subject at increased risk or preclude the subject's full compliance with or completion of the study?
• Require antibiotic premedication prior to dental procedures.
• Have had antibiotic, anti-inflammatory, anti-coagulant medication or chemotherapeutic antiplaque/antigingivitis therapy within 30 days of screening exams.
• participated in any study involving oral care products, concurrently or within the 30 days of screening exams.
• Unwilling to discontinue use of other oral hygiene products for the duration of the study.
• Present use of any tobacco products.
• Presence of severe periodontal disease or being actively treated for periodontal disease.
• Have grossly carious, fully crowned, or extensively restored teeth.
• Have orthodontic appliances, peri/oral piercings, or removable partial dentures.
• Have significant oral soft tissue pathology based on a visual examination.

Sponsors & Collaborators

• Lander Enterprises, LLC: lead

Study Sites (1)

Timber Falls Dental Research

Fort Wayne, Indiana, 46825, United States

Location

Study Officials

• Robert T. Nierman, DMD, MS

  Timber Falls Dental Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Examiner-blind only, subjects will receive treatment assignment and instructions in a room separate from the examiner and exam area.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: November 6, 2023
• First Posted: November 13, 2023
• Study Start: September 11, 2023
• Primary Completion: October 27, 2023
• Study Completion: October 27, 2023
• Last Updated: November 13, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)