Status:
COMPLETED
Plaque and Gingivitis Evaluation of a U-Shaped Toothbrush in a 30-Day Model
Lead Sponsor:
Lander Enterprises, LLC
Conditions:
Plaque Induced Gingivitis
Eligibility:
All Genders
5-65 years
Phase:
NA
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,...
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 a...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 31 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 14 2023
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT06122376
Start Date
May 31 2023
End Date
July 14 2023
Last Update
November 8 2023
Active Locations (1)
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1
Salus Research, Inc
Fort Wayne, Indiana, United States, 46825