Clinical trial NCT06122376: Plaque and Gingivitis Evaluation of a U-Shaped Toothbrush in a 30-Day Model
Official title: Clinical Safety and Efficacy of AutoBrush® 360° U-Shaped Sonic Toothbrush on Plaque and Gingivitis in a 30-Day Model
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Plaque Induced Gingivitis
Keywords: gingivitis
dental plaque
Power toothbrush
manual toothbrush
Lead sponsor: Lander Enterprises, LLC
Sponsor class: INDUSTRY
First posted: 2023-11-08
Enrollment: 75
Sex: ALL
Minimum age (years): 5
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this 30 day, randomized, two group, parallel, examiner-blind clinical trial is to assess the safety and efficacy of AutoBrush® 360° U-shaped Sonic Toothbrush on 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.

Detailed description: This single-center, randomized, controlled, examiner-blind, 30-day parallel study will consist of Screening and Baseline visits with approximately 80 subjects (age 5-65 years) who will read and sign an informed consent form and assent form, assessed for evidence of gingivitis and plaque according to the Modified Gingival Index (MGI) and the Lobene-Soparkar Modification of Turesky Modified Quigley-Hein Plaque Index (LSPI) at Baseline, Day 15 and Day 30. Gingival recession and gingival abrasion will be measured at all visits. Subjects will be randomly assigned to one of two groups twice daily brushing with ADA accepted fluoride toothpaste and 1) two-minute brushing with ADA reference standard manual toothbrush, or 2) 30-second brushing with AutoBrush® 360° U-shaped Sonic Toothbrush.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Gingivitis: Modified Gingival Index
timeFrame: Whole mouth mean change from Baseline in MGI scores at Day 30.
measure: Plaque: Lobene-Soparkar Modification of Turesky Modification of Quigley-Hein Plaque Index
timeFrame: Whole mouth mean change in LSPI scores at Day 30, immediate post-brushing (Pre- to Post-Brushing scores)
Secondary outcomes:
measure: Gingivitis
timeFrame: Change from Baseline at Day 15 and Day 30
measure: Plaque
timeFrame: Change from Baseline at Day 15 and Day 30
measure: Safety: gingival recession
timeFrame: Changes from Baseline at Day 15 and Day 30
measure: Safety: gingival abrasion
timeFrame: Changes from Baseline at Day 15 and Day 30
Other outcomes:
Locations:
city: Fort Wayne
country: United States
facility: Salus Research, Inc
state: Indiana
Study officials:
affiliation: Salus Research
name: Jeffery L Milleman
role: PRINCIPAL_INVESTIGATOR
References: