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NCT01224158 · ClinicalTrials.gov registry record · NA

Study of an Experimental Toothbrush for Treatment and Prevention of Gingivitis

A NA study, sponsored by Johnson & Johnson Consumer and Personal Products Worldwide.

Completed
Registry status
NA
Development phase
153
Enrollment target

NCT01224158: Completed NA study, sponsored by Johnson & Johnson Consumer and Personal Products Worldwide.

NCT01224158 is a NA study that has completed, run by Johnson & Johnson Consumer and Personal Products Worldwide. The registered enrollment target is 153 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (89% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01224158, a NA study, has completed, sponsored by Johnson & Johnson Consumer and Personal Products Worldwide.

COMPLETED
Registry status
NA
Development phase
153 participants
Enrollment target

Study Summary

This study is 6 weeks long with 6 visits to a clinical site. People participating in this study will be asked to brush their teeth two times a day with a provided toothbrush. For one of those six weeks people will be asked to rinse with a mouthwash. During that time, people will use the mouthwash two times a day and will not be allowed to brush their teeth at all. The mouth, teeth, tongue and gums will be looked at by a dentist. At each visit, people will rinse with a pink liquid that will dye their mouths pink. The dye is temporary and will go away by the end of the day. They may also be asked to complete a short questionnaire about their experience.

Primary Outcome

Gingivitis was assessed by the Modified Gingival Index on the buccal and lingual marginal gingiva and interdental papillae of all scorable teeth by the dental examiner using following scale score range from 0 to 4, where 0 - Normal (absence of inflammation); 1 - Mild inflammation (slight change in color, little change in texture) of any portion of the gingival unit; 2 - Mild inflammation of the entire gingival unit; 3 - Moderate inflammation (moderate glazing, redness, edema, and/or hypertrophy)

Interventions

  • DEVICE Experimental Power Toothbrush
  • DEVICE Flat trimmed Manual Toothbrush

Trial Details

FieldValue
Enrollment Target 153 participants
Start Date 2010-09-13
Est. Completion 2010-10-29
Phase NA

What the finished NCT01224158 record still lists

NCT01224158 is an interventional study that assigns participants to a tested intervention. The registered 153 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (89% lower).

The record links to 0 conditions, and to 2 interventions - of which Experimental Power Toothbrush is the first listed.

NCT01224158 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01224158 about?

NCT01224158 is a clinical study titled "Study of an Experimental Toothbrush for Treatment and Prevention of Gingivitis". This study is 6 weeks long with 6 visits to a clinical site. People participating in this study will be asked to brush their teeth two times a day with a provided toothbrush. For one of those six weeks people will be asked to rinse with a mouthwash. During that time, people will use the mouthwash tw...

What is the current status of trial NCT01224158?

This trial is currently completed. It is a NA study. The enrollment target is 153 participants. The study started on 2010-09-13. Estimated completion is 2010-10-29.

What interventions are being tested in trial NCT01224158?

The interventions under investigation include: Experimental Power Toothbrush (DEVICE), Flat trimmed Manual Toothbrush (DEVICE).

Who is sponsoring clinical trial NCT01224158?

This trial is sponsored by Johnson & Johnson Consumer and Personal Products Worldwide, which has 26 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01224158's enrollment target sits among peer trials

153 656th of 2000 higher than 1,343 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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Source: ClinicalTrials.gov NCT01224158, the US trial registry maintained by the National Library of Medicine. NCT01224158 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.