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NCT01009554 · ClinicalTrials.gov registry record · NA
Oral Tissue Tolerance of a Mouthrinse
A NA study, sponsored by Johnson & Johnson Consumer and Personal Products Worldwide.
- Completed
- Registry status
- NA
- Development phase
- 96
- Enrollment target
NCT01009554: Completed NA study, sponsored by Johnson & Johnson Consumer and Personal Products Worldwide.
NCT01009554 is a NA study that has completed, run by Johnson & Johnson Consumer and Personal Products Worldwide. The registered enrollment target is 96 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01009554, a NA study, has completed, sponsored by Johnson & Johnson Consumer and Personal Products Worldwide.
- COMPLETED
- Registry status
- NA
- Development phase
- 96 participants
- Enrollment target
Study Summary
This study is 8 weeks long. People participating in this study will be asked to brush their teeth two times a day. Some people will get a mouthwash. People with a mouthwash will rinse two times a day after brushing their teeth. The mouth, teeth, tongue and gums will be looked at by a dentist. The dentist will look at the mouth to make sure the mouthwash does not irritate the mouth. The dentist will also look at the color of the teeth and amount of stain on the front teeth.
Primary Outcome
The tooth color of the four maxillary incisor teeth (teeth #7-10, facial surface) was measured instrumentally using the MHT SpectroShade System. Assessments were made under standardized lighting conditions after participants brushed their teeth with water. The aperture tip was placed perpendicularly to the facial surface of the tooth and the color measured using the CIElab color system. The changes in the individual L\*, a\*, and b\* color parameters were calculated to determine quantitatively t
Interventions
- DRUG Sodium Fluoride Dentifrice
- DEVICE Potassium Oxylate Mouthwash
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 96 participants |
| Start Date | 2009-10 |
| Est. Completion | 2009-12 |
| Phase | NA |
What the finished NCT01009554 record still lists
NCT01009554 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 96 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (93% lower).
The record links to 0 conditions, and to 2 interventions - of which Sodium Fluoride Dentifrice is the first listed.
NCT01009554 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01009554 about?
NCT01009554 is a clinical study titled "Oral Tissue Tolerance of a Mouthrinse". This study is 8 weeks long. People participating in this study will be asked to brush their teeth two times a day. Some people will get a mouthwash. People with a mouthwash will rinse two times a day after brushing their teeth. The mouth, teeth, tongue and gums will be looked at by a dentist. The de...
What is the current status of trial NCT01009554?
This trial is currently completed. It is a NA study. The enrollment target is 96 participants. The study started on 2009-10. Estimated completion is 2009-12.
What interventions are being tested in trial NCT01009554?
The interventions under investigation include: Sodium Fluoride Dentifrice (DRUG), Potassium Oxylate Mouthwash (DEVICE).
Who is sponsoring clinical trial NCT01009554?
This trial is sponsored by Johnson & Johnson Consumer and Personal Products Worldwide, which has 26 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01009554's enrollment target sits among peer trials
96 925th of 2000 higher than 1,070 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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