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NCT04696536 · ClinicalTrials.gov registry record · Phase 4
A Twelve Week Study of Supervised Mouth Rinse and Flossing
A Phase 4 study of Healthy, sponsored by Johnson & Johnson Consumer Inc. (J&JCI).
- Completed
- Registry status
- Phase 4
- Development phase
- 149
- Enrollment target
- 1
- Study location
NCT04696536: Completed Phase 4 study of Healthy, sponsored by Johnson & Johnson Consumer Inc. (J&JCI).
NCT04696536 is a Phase 4 study of Healthy that has completed, run by Johnson & Johnson Consumer Inc. (J&JCI). The registered enrollment target is 149 participants, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (77% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04696536, a Phase 4 study of Healthy, has completed, sponsored by Johnson & Johnson Consumer Inc. (J&JCI).
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 149 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to evaluate the efficacy of twice daily alcohol containing essential oil mouth rinse and brushing versus dental flossing and brushing under once daily supervision for the prevention and reduction of plaque and gingivitis.
Primary Outcome
Plaque area will be assessed using the Turesky Modification of the Quigley- Hein Plaque Index, on six surfaces (disto-buccal, mid-buccal, mesio-buccal and disto-lingual, mid-lingual, and mesio-lingual) of all scorable teeth, following disclosing: 0 - No plaque; 1 - Separate flecks or discontinuous band of plaque at the gingival (cervical0 margin); 2- Thin (up to 1 millimeter), continuous band of plaque at the gingival margin; 3 - Band of plaque wider than 1 mm but less than 1/3 of surface; 4 - P
Conditions Studied
Interventions
- OTHER Colgate Cavity Protection Toothpaste
- OTHER American Dental Association (ADA) Referenced Toothbrush
- OTHER 5% Hydroalcohol Mouth Rinse
- OTHER REACH Dental Floss
- OTHER Alcohol-containing Essential Oil (AEO) Mouth Rinse (Listerine Cool Mint, marketed)
Study Locations (1)
Indiana
- Salus Research, Inc. - Fort Wayne
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 149 participants |
| Start Date | 2018-09-26 |
| Est. Completion | 2018-12-21 |
| Phase | Phase 4 |
What the finished NCT04696536 record still lists
NCT04696536 is an interventional study that assigns participants to a tested intervention. The registered 149 participants enrollment target is mid-sized for trials with a published cap, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (77% lower).
The record links to 1 condition, with Healthy appearing as the primary indexed condition, and to 5 interventions - of which Colgate Cavity Protection Toothpaste is the first listed.
NCT04696536 reports a single indexed study location in Indiana.
Frequently Asked Questions
What is clinical trial NCT04696536 about?
NCT04696536 is a clinical study titled "A Twelve Week Study of Supervised Mouth Rinse and Flossing". The purpose of this study is to evaluate the efficacy of twice daily alcohol containing essential oil mouth rinse and brushing versus dental flossing and brushing under once daily supervision for the prevention and reduction of plaque and gingivitis.
What is the current status of trial NCT04696536?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 149 participants. The study started on 2018-09-26. Estimated completion is 2018-12-21.
What conditions does trial NCT04696536 study?
This clinical trial studies the following conditions: Healthy.
What interventions are being tested in trial NCT04696536?
The interventions under investigation include: Colgate Cavity Protection Toothpaste (OTHER), American Dental Association (ADA) Referenced Toothbrush (OTHER), 5% Hydroalcohol Mouth Rinse (OTHER), REACH Dental Floss (OTHER), Alcohol-containing Essential Oil (AEO) Mouth Rinse (Listerine Cool Mint, marketed) (OTHER).
Who is sponsoring clinical trial NCT04696536?
This trial is sponsored by Johnson & Johnson Consumer Inc. (J&JCI), which has 40 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04696536 being conducted?
This trial has 1 study location across Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Healthy
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04696536's enrollment target sits among peer trials
149 157th of 1090 higher than 934 of 1,090 other Healthy trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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