Oral Tissue Tolerance of a Mouthrinse
Assessment of the Oral Tissue Tolerance of a Potassium Oxalate Containing Mouthrinse
Sponsor study identifier
interventional
96
1 country
1
Study Start
October 2009
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2009
Actual (reported)Study Completion
December 2009
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2009
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 2009
Date type not reportedThis date has not been verified as actual or estimated.
November 5, 2009
Actual (reported)November 6, 2009
Actual (reported)December 2009
Actual (reported)December 2009
Actual (reported)July 3, 2015
Actual (reported)Change in Tooth Color as Represented by ΔE at 8 Weeks Post Baseline From the CIElab Assessment
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 the improvements in tooth lightness, redness, and yellowness, respectively. An overall change in tooth color was calculated using the CIE color equation ΔE = \[(ΔL\*)\^2 + (Δa\*)\^2 + (Δb\*)\^2\]\^1/2. The ΔE was calculated per tooth and then averaged over the teeth for a participant.
8 weeks
Oral Tissue Tolerance
Oral tissue tolerance was assessed by oral tissue adverse events for which the relationship to treatment was considered as possible, probable, or very likely. If the relationship to treatment was missing, the adverse event was categorized as a treatment-related adverse event.
through 8 weeks
Change in Tooth Color as Represented by ΔE at 4 Weeks Post Baseline From the CIElab Assessment
4 weeks
Change in Tooth Color as Represented by ΔE at 6 Weeks Post Baseline From the CIElab Assessment
6 weeks
Change in Tooth Color as Represented by ΔL at 4 Weeks Post Baseline From the CIElab Assessment
4 weeks
Change in Tooth Color as Represented by ΔL at 6 Weeks Post Baseline From the CIElab Assessment
6 weeks
Change in Tooth Color as Represented by ΔL at 8 Weeks Post Baseline From the CIElab Assessment
8 weeks
1.5% potassium oxalate sensitive mouthwash
Sodium Fluoride Dentifrice
Rinse with 10 mL for 60 seconds, twice daily after brushing in usual manner with a sodium fluoride dentifrice
Brush in usual manner, twice daily, with a sodium fluoride dentifrice
TKL Reearch, Inc.
Paramus, New Jersey, 07652, United States
Michael Lynch, DMD, PhD
Johnson & Johnson Consumer and Personal Products Worldwide
96 participants (actual enrollment reported by the registry).
First Submitted
November 5, 2009
First Posted
November 6, 2009
Study Start
October 2009
Date type not reportedThis date has not been verified as actual or estimated.
CHEER Oral Health in Pregnancy Study
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
December 2009
Actual (reported)Study Completion
December 2009
Actual (reported)Last Updated
July 3, 2015
Results First Posted
July 3, 2015
Record last verified: 2015-06
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Source: ClinicalTrials.gov.
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