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NCT06122376 · ClinicalTrials.gov registry record · NA
Plaque and Gingivitis Evaluation of a U-Shaped Toothbrush in a 30-Day Model
A NA study of Plaque Induced Gingivitis, sponsored by Lander Enterprises.
- Completed
- Registry status
- NA
- Development phase
- 75
- Enrollment target
- 1
- Study location
NCT06122376: Completed NA study of Plaque Induced Gingivitis, sponsored by Lander Enterprises.
NCT06122376 is a NA study of Plaque Induced Gingivitis that has completed, run by Lander Enterprises. The registered enrollment target is 75 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06122376, a NA study of Plaque Induced Gingivitis, has completed, sponsored by Lander Enterprises.
- COMPLETED
- Registry status
- NA
- Development phase
- 75 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
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 hypertrop
Conditions Studied
Interventions
- DEVICE U-shaped Power Toothbrush
- DEVICE Soft Manual Toothbrush
Study Locations (1)
Indiana
- Salus Research, Inc - Fort Wayne
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 75 participants |
| Start Date | 2023-05-31 |
| Est. Completion | 2023-07-14 |
| Phase | NA |
What the finished NCT06122376 record still lists
NCT06122376 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 75 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower).
The record links to 1 condition, with Plaque Induced Gingivitis appearing as the primary indexed condition, and to 2 interventions - of which U-shaped Power Toothbrush is the first listed.
NCT06122376 reports a single indexed study location in Indiana.
Frequently Asked Questions
What is clinical trial NCT06122376 about?
NCT06122376 is a clinical study titled "Plaque and Gingivitis Evaluation of a U-Shaped Toothbrush in a 30-Day Model". 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 gi...
What is the current status of trial NCT06122376?
This trial is currently completed. It is a NA study. The enrollment target is 75 participants. The study started on 2023-05-31. Estimated completion is 2023-07-14.
What conditions does trial NCT06122376 study?
This clinical trial studies the following conditions: Plaque Induced Gingivitis.
What interventions are being tested in trial NCT06122376?
The interventions under investigation include: U-shaped Power Toothbrush (DEVICE), Soft Manual Toothbrush (DEVICE).
Who is sponsoring clinical trial NCT06122376?
This trial is sponsored by Lander Enterprises, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06122376 being conducted?
This trial has 1 study location across Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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