A Phase 4 interventional study of Marketed toothpaste and Marketed Cavity Protection Toothpaste in Gingivitis, sponsored by Procter and Gamble. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-12-04.
Sponsored by Procter and Gamble · Phase 4, Interventional, and Treatment
The objective of this clinical study is to assess the effects of a 0.454% stannous fluoride dentifrice on gingivitis and plaque after 3 months when compared to a negative control.
590 studies on the registry are indexed under Gingivitis; 104 are open to participants now.
This study's enrollment of 84 is above the median of 64 across 478 interventional studies indexed under Gingivitis.
Browse Gingivitis studies →Procter and Gamble is the lead sponsor of 80 studies on the registry; none are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 10 (100%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Brush twice daily
Drug: Marketed toothpaste
Brush twice daily
Drug: Marketed Cavity Protection Toothpaste
Marketed stannous fluoride (0.454%) toothpaste
Marketed sodium monofluorophosphate (0.76 %) toothpaste
Löe-Silness Gingivitis Evaluation
Löe-Silness Gingivitis Evaluation is a validated assessment of gingival health looking at inflammation and bleeding based on a 4 point range 0 (normal gingiva) to 3 (severe inflammation).
Time frame: Baseline
Löe-Silness Gingivitis Evaluation
Löe-Silness Gingivitis Evaluation is a validated assessment of gingival health looking at inflammation and bleeding based on a 4 point range 0 (normal gingiva) to 3 (severe inflammation).
Time frame: 1 Month
Löe-Silness Gingivitis Evaluation
Löe-Silness Gingivitis Evaluation is a validated assessment of gingival health looking at inflammation and bleeding based on a 4 point range 0 (normal gingiva) to 3 (severe inflammation).
Time frame: 3 Months
Turesky Modified Quigley-Hein Index
The Turesky Modified Quigley-Hein Index is a validated assessment of dental plaque based on a scale of 0 (no plaque/debris) to 5 (plaque covering two-thirds or more of the side of the crown or tooth).
Time frame: Baseline
Turesky Modified Quigley-Hein Index
The Turesky Modified Quigley-Hein Index is a validated assessment of dental plaque based on a scale of 0 (no plaque/debris) to 5 (plaque covering two-thirds or more of the side of the crown or tooth).
Time frame: 1 Month
Turesky Modified Quigley-Hein Index
The Turesky Modified Quigley-Hein Index is a validated assessment of dental plaque based on a scale of 0 (no plaque/debris) to 5 (plaque covering two-thirds or more of the side of the crown or tooth).
Time frame: 3 Months
This study is completed, as verified in Dec 2019. You cannot join it, but the record below documents what was studied.
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Procter and Gamble