Trial Outcomes & Findings for Oral Tissue Tolerance of a Mouthrinse (NCT NCT01009554)

NCT ID: NCT01009554

Last Updated: 2015-07-03

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 96 participants
• Primary outcome timeframe: 8 weeks
• Results posted on: 2015-07-03

Participant Flow

Participant milestones

Measure	Crest® Regular Toothpaste Crest® Cavity Protection Regular Toothpaste (Brushing Only)	11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse) Crest® Cavity Protection followed by 1.5% Potassium Oxalate \& pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
Overall Study STARTED	48	48
Overall Study COMPLETED	46	41
Overall Study NOT COMPLETED	2	7

Reasons for withdrawal

Measure	Crest® Regular Toothpaste Crest® Cavity Protection Regular Toothpaste (Brushing Only)	11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse) Crest® Cavity Protection followed by 1.5% Potassium Oxalate \& pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
Overall Study Adverse Event	1	1
Overall Study Withdrawal by Subject	1	3
Overall Study Noncompliant with Study Product	0	3

Baseline Characteristics

Oral Tissue Tolerance of a Mouthrinse

Baseline characteristics by cohort

Measure	Crest® Regular Toothpaste n=48 Participants Crest® Cavity Protection Regular Toothpaste (Brushing Only)	11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse) n=48 Participants Crest® Cavity Protection followed by 1.5% Potassium Oxalate \& pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)	Total n=96 Participants Total of all reporting groups
Age, Continuous	47.6 years STANDARD_DEVIATION 9.96 • n=93 Participants	49.8 years STANDARD_DEVIATION 8.08 • n=4 Participants	48.7 years STANDARD_DEVIATION 9.08 • n=27 Participants
Sex: Female, Male Female	40 Participants n=93 Participants	40 Participants n=4 Participants	80 Participants n=27 Participants
Sex: Female, Male Male	8 Participants n=93 Participants	8 Participants n=4 Participants	16 Participants n=27 Participants
Region of Enrollment USA	48 participants n=93 Participants	48 participants n=4 Participants	96 participants n=27 Participants

PRIMARY outcome

Timeframe: 8 weeks

Population: Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy 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.

Outcome measures

Measure	Crest® Regular Toothpaste n=46 Participants Crest® Cavity Protection Regular Toothpaste (Brushing Only)	11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse) n=41 Participants Crest® Cavity Protection followed by 1.5% Potassium Oxalate \& pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
Change in Tooth Color as Represented by ΔE at 8 Weeks Post Baseline From the CIElab Assessment	0.909 units on a scale Standard Error 0.0612	1.035 units on a scale Standard Error 0.0650

PRIMARY outcome

Timeframe: through 8 weeks

Population: Analysis was based on the Safety Analysis Set, defined as all participants who used at least one dose of investigational product.

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.

Outcome measures

Measure	Crest® Regular Toothpaste n=48 Participants Crest® Cavity Protection Regular Toothpaste (Brushing Only)	11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse) n=48 Participants Crest® Cavity Protection followed by 1.5% Potassium Oxalate \& pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
Oral Tissue Tolerance Participants with ≥ one treatment-related AE	2.1 percentage of participants	0.0 percentage of participants
Oral Tissue Tolerance Sensitivity of teeth	2.1 percentage of participants	0.0 percentage of participants

SECONDARY outcome

Timeframe: 4 weeks

Population: Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy 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.

Outcome measures

Measure	Crest® Regular Toothpaste n=47 Participants Crest® Cavity Protection Regular Toothpaste (Brushing Only)	11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse) n=45 Participants Crest® Cavity Protection followed by 1.5% Potassium Oxalate \& pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
Change in Tooth Color as Represented by ΔE at 4 Weeks Post Baseline From the CIElab Assessment	0.875 units on a scale Standard Error 0.0464	0.882 units on a scale Standard Error 0.0475

SECONDARY outcome

Timeframe: 6 weeks

Population: Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy 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.

Outcome measures

Measure	Crest® Regular Toothpaste n=46 Participants Crest® Cavity Protection Regular Toothpaste (Brushing Only)	11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse) n=44 Participants Crest® Cavity Protection followed by 1.5% Potassium Oxalate \& pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
Change in Tooth Color as Represented by ΔE at 6 Weeks Post Baseline From the CIElab Assessment	0.805 units on a scale Standard Error 0.0496	1.040 units on a scale Standard Error 0.0507

SECONDARY outcome

Timeframe: 4 weeks

Population: Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy 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 change in the individual L* color parameter was calculated. The ΔL was calculated per tooth and then averaged over the teeth for a participant.

Outcome measures

Measure	Crest® Regular Toothpaste n=47 Participants Crest® Cavity Protection Regular Toothpaste (Brushing Only)	11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse) n=45 Participants Crest® Cavity Protection followed by 1.5% Potassium Oxalate \& pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
Change in Tooth Color as Represented by ΔL at 4 Weeks Post Baseline From the CIElab Assessment	0.013 units on a scale Standard Error 0.0857	0.054 units on a scale Standard Error 0.0876

SECONDARY outcome

Timeframe: 6 weeks

Population: Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy 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 change in the individual L* color parameter was calculated. The ΔL was calculated per tooth and then averaged over the teeth for a participant.

Outcome measures

Measure	Crest® Regular Toothpaste n=46 Participants Crest® Cavity Protection Regular Toothpaste (Brushing Only)	11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse) n=44 Participants Crest® Cavity Protection followed by 1.5% Potassium Oxalate \& pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
Change in Tooth Color as Represented by ΔL at 6 Weeks Post Baseline From the CIElab Assessment	0.071 units on a scale Standard Error 0.0959	-0.090 units on a scale Standard Error 0.0981

SECONDARY outcome

Timeframe: 8 weeks

Population: Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy 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 change in the individual L* color parameter was calculated. The ΔL was calculated per tooth and then averaged over the teeth for a participant.

Outcome measures

Measure	Crest® Regular Toothpaste n=46 Participants Crest® Cavity Protection Regular Toothpaste (Brushing Only)	11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse) n=41 Participants Crest® Cavity Protection followed by 1.5% Potassium Oxalate \& pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
Change in Tooth Color as Represented by ΔL at 8 Weeks Post Baseline From the CIElab Assessment	0.158 units on a scale Standard Error 0.0949	-0.043 units on a scale Standard Error 0.1006

SECONDARY outcome

Timeframe: 4 weeks

Population: Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy 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 change in the individual b* color parameter was calculated. The Δb was calculated per tooth and then averaged over the teeth for a participant.

Outcome measures

Measure	Crest® Regular Toothpaste n=47 Participants Crest® Cavity Protection Regular Toothpaste (Brushing Only)	11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse) n=45 Participants Crest® Cavity Protection followed by 1.5% Potassium Oxalate \& pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
Change in Tooth Color as Represented by Δb at 4 Weeks Post Baseline From the CIElab Assessment	0.077 units on a scale Standard Error 0.0518	-0.117 units on a scale Standard Error 0.0529

SECONDARY outcome

Timeframe: 6 weeks

Population: Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy 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 change in the individual b* color parameter was calculated. The Δb was calculated per tooth and then averaged over the teeth for a participant.

Outcome measures

Measure	Crest® Regular Toothpaste n=46 Participants Crest® Cavity Protection Regular Toothpaste (Brushing Only)	11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse) n=44 Participants Crest® Cavity Protection followed by 1.5% Potassium Oxalate \& pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
Change in Tooth Color as Represented by Δb at 6 Weeks Post Baseline From the CIElab Assessment	0.123 units on a scale Standard Error 0.0487	-0.212 units on a scale Standard Error 0.0498

SECONDARY outcome

Timeframe: 8 weeks

Population: Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy 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 change in the individual b* color parameter was calculated. The Δb was calculated per tooth and then averaged over the teeth for a participant.

Outcome measures

Measure	Crest® Regular Toothpaste n=46 Participants Crest® Cavity Protection Regular Toothpaste (Brushing Only)	11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse) n=41 Participants Crest® Cavity Protection followed by 1.5% Potassium Oxalate \& pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
Change in Tooth Color as Represented by Δb at 8 Weeks Post Baseline From the CIElab Assessment	0.107 units on a scale Standard Error 0.0639	-0.107 units on a scale Standard Error 0.0677

SECONDARY outcome

Timeframe: 4 weeks

Population: Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.

The mean stain score (0-9) per participant was determined by multiplying the individual area and intensity scores from each region and summing them then dividing by the number of sites scored. The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for area and intensity according to the following criteria. Stain area for mesial, gingival, and distal regions were scored on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain covers entire area) and for the body of tooth on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain outside pits/grooves, over 10% of surface affected). The intensity of yellow-brown stains occurring in each region was assessed on a 4-point ordinal scale (0=no stain; 3=heavy, dark stain).

Outcome measures

Measure	Crest® Regular Toothpaste n=47 Participants Crest® Cavity Protection Regular Toothpaste (Brushing Only)	11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse) n=45 Participants Crest® Cavity Protection followed by 1.5% Potassium Oxalate \& pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
Mean Stain Score Over All Tooth Sites at 4 Weeks	0.329 units on a scale Standard Error 0.0464	0.386 units on a scale Standard Error 0.0505

SECONDARY outcome

Timeframe: 6 weeks

Population: Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.

The mean stain score (0-9) per participant was determined by multiplying the individual area and intensity scores from each region and summing them then dividing by the number of sites scored. The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for area and intensity according to the following criteria. Stain area for mesial, gingival, and distal regions were scored on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain covers entire area) and for the body of tooth on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain outside pits/grooves, over 10% of surface affected). The intensity of yellow-brown stains occurring in each region was assessed on a 4-point ordinal scale (0=no stain; 3=heavy, dark stain).

Outcome measures

Measure	Crest® Regular Toothpaste n=46 Participants Crest® Cavity Protection Regular Toothpaste (Brushing Only)	11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse) n=44 Participants Crest® Cavity Protection followed by 1.5% Potassium Oxalate \& pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
Mean Stain Score Over All Tooth Sites at 6 Weeks	0.349 units on a scale Standard Error 0.0565	0.621 units on a scale Standard Error 0.0605

SECONDARY outcome

Timeframe: 8 weeks

Population: Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.

The mean stain score (0-9) per participant was determined by multiplying the individual area and intensity scores from each region and summing them then dividing by the number of sites scored. The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for area and intensity according to the following criteria. Stain area for mesial, gingival, and distal regions were scored on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain covers entire area) and for the body of tooth on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain outside pits/grooves, over 10% of surface affected). The intensity of yellow-brown stains occurring in each region was assessed on a 4-point ordinal scale (0=no stain; 3=heavy, dark stain).

Outcome measures

Measure	Crest® Regular Toothpaste n=46 Participants Crest® Cavity Protection Regular Toothpaste (Brushing Only)	11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse) n=41 Participants Crest® Cavity Protection followed by 1.5% Potassium Oxalate \& pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
Mean Stain Score Over All Tooth Sites at 8 Weeks	0.394 units on a scale Standard Error 0.0703	0.791 units on a scale Standard Error 0.0785

SECONDARY outcome

Timeframe: 4 weeks

Population: Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.

The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for intensity according to the following criteria. The intensity of yellow-brown stains occurring in each region is unrelated to the area covered with stained pellicle. All four regions were assessed on a 4-point ordinal scale as 0=no stain, 1=faint stain (can be seen with close examination), 2=moderate stain (clearly visible and aesthetically unacceptable), 3=heavy, dark stain (obvious and aesthetically unacceptable).

Outcome measures

Measure	Crest® Regular Toothpaste n=47 Participants Crest® Cavity Protection Regular Toothpaste (Brushing Only)	11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse) n=45 Participants Crest® Cavity Protection followed by 1.5% Potassium Oxalate \& pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
Mean Stain Intensity Over All Tooth Sites at 4 Weeks	0.154 units on a scale Standard Error 0.0224	0.184 units on a scale Standard Error 0.0243

SECONDARY outcome

Timeframe: 6 weeks

Population: Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.

The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for intensity according to the following criteria. The intensity of yellow-brown stains occurring in each region is unrelated to the area covered with stained pellicle. All four regions were assessed on a 4-point ordinal scale as 0=no stain, 1=faint stain (can be seen with close examination), 2=moderate stain (clearly visible and aesthetically unacceptable), 3=heavy, dark stain (obvious and aesthetically unacceptable).

Outcome measures

Measure	Crest® Regular Toothpaste n=46 Participants Crest® Cavity Protection Regular Toothpaste (Brushing Only)	11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse) n=44 Participants Crest® Cavity Protection followed by 1.5% Potassium Oxalate \& pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
Mean Stain Intensity Over All Tooth Sites at 6 Weeks	0.164 units on a scale Standard Error 0.0274	0.302 units on a scale Standard Error 0.0293

SECONDARY outcome

Timeframe: 8 weeks

Population: Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.

The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for intensity according to the following criteria. The intensity of yellow-brown stains occurring in each region is unrelated to the area covered with stained pellicle. All four regions were assessed on a 4-point ordinal scale as 0=no stain, 1=faint stain (can be seen with close examination), 2=moderate stain (clearly visible and aesthetically unacceptable), 3=heavy, dark stain (obvious and aesthetically unacceptable).

Outcome measures

Measure	Crest® Regular Toothpaste n=46 Participants Crest® Cavity Protection Regular Toothpaste (Brushing Only)	11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse) n=41 Participants Crest® Cavity Protection followed by 1.5% Potassium Oxalate \& pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
Mean Stain Intensity Over All Tooth Sites at 8 Weeks	0.181 units on a scale Standard Error 0.0334	0.375 units on a scale Standard Error 0.0372

SECONDARY outcome

Timeframe: 4 weeks

Population: Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.

The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for area according to the following criteria. Stain area for mesial, gingival, and distal regions were scored as 0=no stain present, natural tooth color; 1=thin line of stain, may be discontinuous; 2=thick line or band of stain; 3=stain covers entire area and for the body of tooth as 0=no stain present, natural tooth color, 1=stain limited to pits and grooves; 2=stain outside pits/grooves, up to 10% of surface affected; 3=stain outside pits/grooves, over 10% of surface affected.

Outcome measures

Measure	Crest® Regular Toothpaste n=47 Participants Crest® Cavity Protection Regular Toothpaste (Brushing Only)	11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse) n=45 Participants Crest® Cavity Protection followed by 1.5% Potassium Oxalate \& pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
Mean Stain Area Over All Tooth Sites at 4 Weeks	0.162 units on a scale Standard Error 0.0225	0.196 units on a scale Standard Error 0.0245

SECONDARY outcome

Timeframe: 6 weeks

Population: Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.

The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for area according to the following criteria. Stain area for mesial, gingival, and distal regions were scored as 0=no stain present, natural tooth color; 1=thin line of stain, may be discontinuous; 2=thick line or band of stain; 3=stain covers entire area and for the body of tooth as 0=no stain present, natural tooth color, 1=stain limited to pits and grooves; 2=stain outside pits/grooves, up to 10% of surface affected; 3=stain outside pits/grooves, over 10% of surface affected.

Outcome measures

Measure	Crest® Regular Toothpaste n=46 Participants Crest® Cavity Protection Regular Toothpaste (Brushing Only)	11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse) n=44 Participants Crest® Cavity Protection followed by 1.5% Potassium Oxalate \& pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
Mean Stain Area Over All Tooth Sites at 6 Weeks	0.166 units on a scale Standard Error 0.0270	0.303 units on a scale Standard Error 0.0290

SECONDARY outcome

Timeframe: 8 weeks

Population: Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.

The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for area according to the following criteria. Stain area for mesial, gingival, and distal regions were scored as 0=no stain present, natural tooth color; 1=thin line of stain, may be discontinuous; 2=thick line or band of stain; 3=stain covers entire area and for the body of tooth as 0=no stain present, natural tooth color, 1=stain limited to pits and grooves; 2=stain outside pits/grooves, up to 10% of surface affected; 3=stain outside pits/grooves, over 10% of surface affected.

Outcome measures

Measure	Crest® Regular Toothpaste n=46 Participants Crest® Cavity Protection Regular Toothpaste (Brushing Only)	11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse) n=41 Participants Crest® Cavity Protection followed by 1.5% Potassium Oxalate \& pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
Mean Stain Area Over All Tooth Sites at 8 Weeks	0.188 units on a scale Standard Error 0.0340	0.383 units on a scale Standard Error 0.0379

SECONDARY outcome

Timeframe: 4 weeks

Population: Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.

The mean stain score (0-9) per participant was determined by multiplying the individual area and intensity scores from each region and summing them then dividing by the number of sites scored. The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). Stain area for mesial and distal regions were scored on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain covers entire area). The intensity of yellow-brown stains occurring in each region was assessed on a 4-point ordinal scale (0=no stain; 3=heavy, dark stain).

Outcome measures

Measure	Crest® Regular Toothpaste n=47 Participants Crest® Cavity Protection Regular Toothpaste (Brushing Only)	11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse) n=45 Participants Crest® Cavity Protection followed by 1.5% Potassium Oxalate \& pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
Mean Stain Score for Interproximal (Mesial and Distal) Sites at 4 Weeks	0.408 units on a scale Standard Error 0.0590	0.463 units on a scale Standard Error 0.0643

SECONDARY outcome

Timeframe: 6 weeks

Population: Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.

The mean stain score (0-9) per participant was determined by multiplying the individual area and intensity scores from each region and summing them then dividing by the number of sites scored. The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). Stain area for mesial and distal regions were scored on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain covers entire area). The intensity of yellow-brown stains occurring in each region was assessed on a 4-point ordinal scale (0=no stain; 3=heavy, dark stain).

Outcome measures

Measure	Crest® Regular Toothpaste n=46 Participants Crest® Cavity Protection Regular Toothpaste (Brushing Only)	11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse) n=44 Participants Crest® Cavity Protection followed by 1.5% Potassium Oxalate \& pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
Mean Stain Score for Interproximal (Mesial and Distal) Sites at 6 Weeks	0.427 units on a scale Standard Error 0.0712	0.776 units on a scale Standard Error 0.0762

SECONDARY outcome

Timeframe: 8 weeks

Population: Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.

The mean stain score (0-9) per participant was determined by multiplying the individual area and intensity scores from each region and summing them then dividing by the number of sites scored. The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). Stain area for mesial and distal regions were scored on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain covers entire area). The intensity of yellow-brown stains occurring in each region was assessed on a 4-point ordinal scale (0=no stain; 3=heavy, dark stain).

Outcome measures

Measure	Crest® Regular Toothpaste n=46 Participants Crest® Cavity Protection Regular Toothpaste (Brushing Only)	11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse) n=41 Participants Crest® Cavity Protection followed by 1.5% Potassium Oxalate \& pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
Mean Stain Score for Interproximal (Mesial and Distal) Sites at 8 Weeks	0.451 units on a scale Standard Error 0.0889	0.994 units on a scale Standard Error 0.0991

SECONDARY outcome

Timeframe: 4 weeks

Population: Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.

The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). The interproximal (mesial and distal) regions were scored for intensity according to the following criteria. The intensity of yellow-brown stains occurring in each region is unrelated to the area covered with stained pellicle. The regions were assessed on a 4-point ordinal scale as 0=no stain, 1=faint stain (can be seen with close examination), 2=moderate stain (clearly visible and aesthetically unacceptable), 3=heavy, dark stain (obvious and aesthetically unacceptable).

Outcome measures

Measure	Crest® Regular Toothpaste n=47 Participants Crest® Cavity Protection Regular Toothpaste (Brushing Only)	11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse) n=45 Participants Crest® Cavity Protection followed by 1.5% Potassium Oxalate \& pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
Mean Stain Intensity For Interproximal (Mesial and Distal) Sites at 4 Weeks	0.192 units on a scale Standard Error 0.0284	0.224 units on a scale Standard Error 0.0309

SECONDARY outcome

Timeframe: 6 weeks

Population: Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.

The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). The interproximal (mesial and distal) regions were scored for intensity according to the following criteria. The intensity of yellow-brown stains occurring in each region is unrelated to the area covered with stained pellicle. The regions were assessed on a 4-point ordinal scale as 0=no stain, 1=faint stain (can be seen with close examination), 2=moderate stain (clearly visible and aesthetically unacceptable), 3=heavy, dark stain (obvious and aesthetically unacceptable).

Outcome measures

Measure	Crest® Regular Toothpaste n=46 Participants Crest® Cavity Protection Regular Toothpaste (Brushing Only)	11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse) n=44 Participants Crest® Cavity Protection followed by 1.5% Potassium Oxalate \& pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
Mean Stain Intensity For Interproximal (Mesial and Distal) Sites at 6 Weeks	0.205 units on a scale Standard Error 0.0350	0.379 units on a scale Standard Error 0.0374

SECONDARY outcome

Timeframe: 8 weeks

Population: Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.

The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). The interproximal (mesial and distal) regions were scored for intensity according to the following criteria. The intensity of yellow-brown stains occurring in each region is unrelated to the area covered with stained pellicle. The regions were assessed on a 4-point ordinal scale as 0=no stain, 1=faint stain (can be seen with close examination), 2=moderate stain (clearly visible and aesthetically unacceptable), 3=heavy, dark stain (obvious and aesthetically unacceptable).

Outcome measures

Measure	Crest® Regular Toothpaste n=46 Participants Crest® Cavity Protection Regular Toothpaste (Brushing Only)	11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse) n=41 Participants Crest® Cavity Protection followed by 1.5% Potassium Oxalate \& pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
Mean Stain Intensity For Interproximal (Mesial and Distal) Sites at 8 Weeks	0.210 units on a scale Standard Error 0.0422	0.475 units on a scale Standard Error 0.0470

SECONDARY outcome

Timeframe: 4 weeks

Population: Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.

The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). The interproximal (mesial and distal) regions were scored for area according to the following criteria. Stain area for mesial and distal regions were scored as 0=no stain present, natural tooth color; 1=thin line of stain, may be discontinuous; 2=thick line or band of stain; 3=stain covers entire area.

Outcome measures

Measure	Crest® Regular Toothpaste n=47 Participants Crest® Cavity Protection Regular Toothpaste (Brushing Only)	11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse) n=45 Participants Crest® Cavity Protection followed by 1.5% Potassium Oxalate \& pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
Mean Stain Area for Interproximal (Mesial and Distal) Sites at 4 Weeks	0.202 units on a scale Standard Error 0.0284	0.236 units on a scale Standard Error 0.0309

SECONDARY outcome

Timeframe: 6 weeks

Population: Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.

The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). The interproximal (mesial and distal) regions were scored for area according to the following criteria. Stain area for mesial and distal regions were scored as 0=no stain present, natural tooth color; 1=thin line of stain, may be discontinuous; 2=thick line or band of stain; 3=stain covers entire area.

Outcome measures

Measure	Crest® Regular Toothpaste n=46 Participants Crest® Cavity Protection Regular Toothpaste (Brushing Only)	11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse) n=44 Participants Crest® Cavity Protection followed by 1.5% Potassium Oxalate \& pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
Mean Stain Area for Interproximal (Mesial and Distal) Sites at 6 Weeks	0.206 units on a scale Standard Error 0.0348	0.383 units on a scale Standard Error 0.0373

SECONDARY outcome

Timeframe: 8 weeks

Population: Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.

The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). The interproximal (mesial and distal) regions were scored for area according to the following criteria. Stain area for mesial and distal regions were scored as 0=no stain present, natural tooth color; 1=thin line of stain, may be discontinuous; 2=thick line or band of stain; 3=stain covers entire area.

Outcome measures

Measure	Crest® Regular Toothpaste n=46 Participants Crest® Cavity Protection Regular Toothpaste (Brushing Only)	11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse) n=41 Participants Crest® Cavity Protection followed by 1.5% Potassium Oxalate \& pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
Mean Stain Area for Interproximal (Mesial and Distal) Sites at 8 Weeks	0.218 units on a scale Standard Error 0.0433	0.483 units on a scale Standard Error 0.0483

SECONDARY outcome

Timeframe: 4 weeks

Population: Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.

The mean stain score (0-9) per participant was determined by multiplying the individual area and intensity scores from each region and summing them then dividing by the number of sites scored. The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). Stain area for gingival regions were scored on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain covers entire area) and for the body of tooth on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain outside pits/grooves, over 10% of surface affected). The intensity of yellow-brown stains occurring in each region was assessed on a 4-point ordinal scale (0=no stain; 3=heavy, dark stain).

Outcome measures

Measure	Crest® Regular Toothpaste n=47 Participants Crest® Cavity Protection Regular Toothpaste (Brushing Only)	11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse) n=45 Participants Crest® Cavity Protection followed by 1.5% Potassium Oxalate \& pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
Mean Stain Score for Gingival Sites at 4 Weeks	0.383 units on a scale Standard Error 0.0596	0.521 units on a scale Standard Error 0.0652

SECONDARY outcome

Timeframe: 6 weeks

Population: Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.

The mean stain score (0-9) per participant was determined by multiplying the individual area and intensity scores from each region and summing them then dividing by the number of sites scored. The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). Stain area for gingival regions were scored on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain covers entire area) and for the body of tooth on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain outside pits/grooves, over 10% of surface affected). The intensity of yellow-brown stains occurring in each region was assessed on a 4-point ordinal scale (0=no stain; 3=heavy, dark stain).

Outcome measures

Measure	Crest® Regular Toothpaste n=46 Participants Crest® Cavity Protection Regular Toothpaste (Brushing Only)	11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse) n=44 Participants Crest® Cavity Protection followed by 1.5% Potassium Oxalate \& pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
Mean Stain Score for Gingival Sites at 6 Weeks	0.395 units on a scale Standard Error 0.0732	0.732 units on a scale Standard Error 0.0786

SECONDARY outcome

Timeframe: 8 weeks

Population: Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.

The mean stain score (0-9) per participant was determined by multiplying the individual area and intensity scores from each region and summing them then dividing by the number of sites scored. The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). Stain area for gingival regions were scored on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain covers entire area) and for the body of tooth on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain outside pits/grooves, over 10% of surface affected). The intensity of yellow-brown stains occurring in each region was assessed on a 4-point ordinal scale (0=no stain; 3=heavy, dark stain).

Outcome measures

Measure	Crest® Regular Toothpaste n=46 Participants Crest® Cavity Protection Regular Toothpaste (Brushing Only)	11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse) n=41 Participants Crest® Cavity Protection followed by 1.5% Potassium Oxalate \& pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
Mean Stain Score for Gingival Sites at 8 Weeks	0.526 units on a scale Standard Error 0.0914	0.920 units on a scale Standard Error 0.1023

SECONDARY outcome

Timeframe: 4 weeks

Population: Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.

The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). The gingival regions were scored for intensity according to the following criteria. The intensity of yellow-brown stains occurring in each region is unrelated to the area covered with stained pellicle. The gingival regions were assessed on a 4-point ordinal scale as 0=no stain, 1=faint stain (can be seen with close examination), 2=moderate stain (clearly visible and aesthetically unacceptable), 3=heavy, dark stain (obvious and aesthetically unacceptable).

Outcome measures

Measure	Crest® Regular Toothpaste n=47 Participants Crest® Cavity Protection Regular Toothpaste (Brushing Only)	11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse) n=45 Participants Crest® Cavity Protection followed by 1.5% Potassium Oxalate \& pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
Mean Stain Intensity for Gingival Sites at 4 Weeks	0.180 units on a scale Standard Error 0.0292	0.252 units on a scale Standard Error 0.0318

SECONDARY outcome

Timeframe: 6 weeks

Population: Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.

The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). The gingival regions were scored for intensity according to the following criteria. The intensity of yellow-brown stains occurring in each region is unrelated to the area covered with stained pellicle. The gingival regions were assessed on a 4-point ordinal scale as 0=no stain, 1=faint stain (can be seen with close examination), 2=moderate stain (clearly visible and aesthetically unacceptable), 3=heavy, dark stain (obvious and aesthetically unacceptable).

Outcome measures

Measure	Crest® Regular Toothpaste n=46 Participants Crest® Cavity Protection Regular Toothpaste (Brushing Only)	11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse) n=44 Participants Crest® Cavity Protection followed by 1.5% Potassium Oxalate \& pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
Mean Stain Intensity for Gingival Sites at 6 Weeks	0.180 units on a scale Standard Error 0.0350	0.358 units on a scale Standard Error 0.0375

SECONDARY outcome

Timeframe: 8 weeks

Population: Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.

The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). The gingival regions were scored for intensity according to the following criteria. The intensity of yellow-brown stains occurring in each region is unrelated to the area covered with stained pellicle. The gingival regions were assessed on a 4-point ordinal scale as 0=no stain, 1=faint stain (can be seen with close examination), 2=moderate stain (clearly visible and aesthetically unacceptable), 3=heavy, dark stain (obvious and aesthetically unacceptable).

Outcome measures

Measure	Crest® Regular Toothpaste n=46 Participants Crest® Cavity Protection Regular Toothpaste (Brushing Only)	11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse) n=41 Participants Crest® Cavity Protection followed by 1.5% Potassium Oxalate \& pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
Mean Stain Intensity for Gingival Sites at 8 Weeks	0.241 units on a scale Standard Error 0.0434	0.438 units on a scale Standard Error 0.0485

SECONDARY outcome

Timeframe: 4 weeks

Population: Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.

The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). The gingival regions were scored for area according to the following criteria. Stain area for gingival regions were scored as 0=no stain present, natural tooth color; 1=thin line of stain, may be discontinuous; 2=thick line or band of stain; 3=stain covers entire area.

Outcome measures

Measure	Crest® Regular Toothpaste n=47 Participants Crest® Cavity Protection Regular Toothpaste (Brushing Only)	11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse) n=45 Participants Crest® Cavity Protection followed by 1.5% Potassium Oxalate \& pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
Mean Stain Area for Gingival Sites at 4 Weeks	0.186 units on a scale Standard Error 0.0292	0.263 units on a scale Standard Error 0.0319

SECONDARY outcome

Timeframe: 6 weeks

Population: Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.

The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). The gingival regions were scored for area according to the following criteria. Stain area for gingival regions were scored as 0=no stain present, natural tooth color; 1=thin line of stain, may be discontinuous; 2=thick line or band of stain; 3=stain covers entire area.

Outcome measures

Measure	Crest® Regular Toothpaste n=46 Participants Crest® Cavity Protection Regular Toothpaste (Brushing Only)	11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse) n=44 Participants Crest® Cavity Protection followed by 1.5% Potassium Oxalate \& pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
Mean Stain Area for Gingival Sites at 6 Weeks	0.184 units on a scale Standard Error 0.0335	0.352 units on a scale Standard Error 0.0359

SECONDARY outcome

Timeframe: 8 weeks

Population: Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.

The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). The gingival regions were scored for area according to the following criteria. Stain area for gingival regions were scored as 0=no stain present, natural tooth color; 1=thin line of stain, may be discontinuous; 2=thick line or band of stain; 3=stain covers entire area.

Outcome measures

Measure	Crest® Regular Toothpaste n=46 Participants Crest® Cavity Protection Regular Toothpaste (Brushing Only)	11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse) n=41 Participants Crest® Cavity Protection followed by 1.5% Potassium Oxalate \& pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
Mean Stain Area for Gingival Sites at 8 Weeks	0.250 units on a scale Standard Error 0.0430	0.444 units on a scale Standard Error 0.0481

SECONDARY outcome

Timeframe: 4 weeks

Population: Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.

The mean stain score (0-9) per participant was determined by multiplying the individual area and intensity scores from each region and summing them then dividing by the number of sites scored. The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). Stain area for the body of the tooth was scored on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain outside pits/grooves, over 10% of surface affected). The intensity of yellow-brown stains occurring in each region was assessed on a 4-point ordinal scale (0=no stain; 3=heavy, dark stain).

Outcome measures

Measure	Crest® Regular Toothpaste n=47 Participants Crest® Cavity Protection Regular Toothpaste (Brushing Only)	11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse) n=45 Participants Crest® Cavity Protection followed by 1.5% Potassium Oxalate \& pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
Mean Stain Score for Body Sites at 4 Weeks	0.132 units on a scale Standard Error 0.0258	0.112 units on a scale Standard Error 0.0281

SECONDARY outcome

Timeframe: 6 weeks

Population: Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.

The mean stain score (0-9) per participant was determined by multiplying the individual area and intensity scores from each region and summing them then dividing by the number of sites scored. The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). Stain area for the body of the tooth was scored on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain outside pits/grooves, over 10% of surface affected). The intensity of yellow-brown stains occurring in each region was assessed on a 4-point ordinal scale (0=no stain; 3=heavy, dark stain).

Outcome measures

Measure	Crest® Regular Toothpaste n=46 Participants Crest® Cavity Protection Regular Toothpaste (Brushing Only)	11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse) n=44 Participants Crest® Cavity Protection followed by 1.5% Potassium Oxalate \& pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
Mean Stain Score for Body Sites at 6 Weeks	0.160 units on a scale Standard Error 0.0337	0.215 units on a scale Standard Error 0.0361

SECONDARY outcome

Timeframe: 8 weeks

Population: Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.

The mean stain score (0-9) per participant was determined by multiplying the individual area and intensity scores from each region and summing them then dividing by the number of sites scored. The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). Stain area for the body of the tooth was scored on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain outside pits/grooves, over 10% of surface affected). The intensity of yellow-brown stains occurring in each region was assessed on a 4-point ordinal scale (0=no stain; 3=heavy, dark stain).

Outcome measures

Measure	Crest® Regular Toothpaste n=46 Participants Crest® Cavity Protection Regular Toothpaste (Brushing Only)	11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse) n=41 Participants Crest® Cavity Protection followed by 1.5% Potassium Oxalate \& pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
Mean Stain Score for Body Sites at 8 Weeks	0.143 units on a scale Standard Error 0.0371	0.258 units on a scale Standard Error 0.0412

SECONDARY outcome

Timeframe: 4 weeks

Population: Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.

The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). The body regions were scored for intensity according to the following criteria. The intensity of yellow-brown stains occurring in each region is unrelated to the area covered with stained pellicle. The body regions were assessed on a 4-point ordinal scale as 0=no stain, 1=faint stain (can be seen with close examination), 2=moderate stain (clearly visible and aesthetically unacceptable), 3=heavy, dark stain (obvious and aesthetically unacceptable).

Outcome measures

Measure	Crest® Regular Toothpaste n=47 Participants Crest® Cavity Protection Regular Toothpaste (Brushing Only)	11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse) n=45 Participants Crest® Cavity Protection followed by 1.5% Potassium Oxalate \& pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
Mean Stain Intensity for Body Sites at 4 Weeks	0.058 units on a scale Standard Error 0.0121	0.045 units on a scale Standard Error 0.0132

SECONDARY outcome

Timeframe: 6 weeks

Population: Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.

The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). The body regions were scored for intensity according to the following criteria. The intensity of yellow-brown stains occurring in each region is unrelated to the area covered with stained pellicle. The body regions were assessed on a 4-point ordinal scale as 0=no stain, 1=faint stain (can be seen with close examination), 2=moderate stain (clearly visible and aesthetically unacceptable), 3=heavy, dark stain (obvious and aesthetically unacceptable).

Outcome measures

Measure	Crest® Regular Toothpaste n=46 Participants Crest® Cavity Protection Regular Toothpaste (Brushing Only)	11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse) n=44 Participants Crest® Cavity Protection followed by 1.5% Potassium Oxalate \& pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
Mean Stain Intensity for Body Sites at 6 Weeks	0.075 units on a scale Standard Error 0.0160	0.100 units on a scale Standard Error 0.0171

SECONDARY outcome

Timeframe: 8 weeks

Population: Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.

The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). The body regions were scored for intensity according to the following criteria. The intensity of yellow-brown stains occurring in each region is unrelated to the area covered with stained pellicle. The body regions were assessed on a 4-point ordinal scale as 0=no stain, 1=faint stain (can be seen with close examination), 2=moderate stain (clearly visible and aesthetically unacceptable), 3=heavy, dark stain (obvious and aesthetically unacceptable).

Outcome measures

Measure	Crest® Regular Toothpaste n=46 Participants Crest® Cavity Protection Regular Toothpaste (Brushing Only)	11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse) n=41 Participants Crest® Cavity Protection followed by 1.5% Potassium Oxalate \& pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
Mean Stain Intensity for Body Sites at 8 Weeks	0.063 units on a scale Standard Error 0.0166	0.112 units on a scale Standard Error 0.0184

SECONDARY outcome

Timeframe: 4 weeks

Population: Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.

The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). The body regions were scored for area according to the following criteria. Stain area for the body of the tooth was scored as 0=no stain present, natural tooth color, 1=stain limited to pits and grooves; 2=stain outside pits/grooves, up to 10% of surface affected; 3=stain outside pits/grooves, over 10% of surface affected.

Outcome measures

Measure	Crest® Regular Toothpaste n=47 Participants Crest® Cavity Protection Regular Toothpaste (Brushing Only)	11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse) n=45 Participants Crest® Cavity Protection followed by 1.5% Potassium Oxalate \& pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
Mean Stain Area for Body Sites at 4 Weeks	0.064 units on a scale Standard Error 0.0133	0.056 units on a scale Standard Error 0.0145

SECONDARY outcome

Timeframe: 6 weeks

Population: Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.

The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). The body regions were scored for area according to the following criteria. Stain area for the body of the tooth was scored as 0=no stain present, natural tooth color, 1=stain limited to pits and grooves; 2=stain outside pits/grooves, up to 10% of surface affected; 3=stain outside pits/grooves, over 10% of surface affected.

Outcome measures

Measure	Crest® Regular Toothpaste n=46 Participants Crest® Cavity Protection Regular Toothpaste (Brushing Only)	11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse) n=44 Participants Crest® Cavity Protection followed by 1.5% Potassium Oxalate \& pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
Mean Stain Area for Body Sites at 6 Weeks	0.076 units on a scale Standard Error 0.0158	0.100 units on a scale Standard Error 0.0169

SECONDARY outcome

Timeframe: 8 weeks

Population: Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.

The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). The body regions were scored for area according to the following criteria. Stain area for the body of the tooth was scored as 0=no stain present, natural tooth color, 1=stain limited to pits and grooves; 2=stain outside pits/grooves, up to 10% of surface affected; 3=stain outside pits/grooves, over 10% of surface affected.

Outcome measures

Measure	Crest® Regular Toothpaste n=46 Participants Crest® Cavity Protection Regular Toothpaste (Brushing Only)	11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse) n=41 Participants Crest® Cavity Protection followed by 1.5% Potassium Oxalate \& pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
Mean Stain Area for Body Sites at 8 Weeks	0.067 units on a scale Standard Error 0.0180	0.124 units on a scale Standard Error 0.0200

SECONDARY outcome

Timeframe: 4 weeks

Population: Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.

The mean stain score (0-9) per participant was determined by multiplying the individual area and intensity scores from each region and summing them then dividing by the number of sites scored. The facial surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for area and intensity according to the following criteria. Stain area for mesial, gingival, and distal regions were scored on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain covers entire area) and for the body of tooth on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain outside pits/grooves, over 10% of surface affected). The intensity of yellow-brown stains occurring in each region was assessed on a 4-point ordinal scale (0=no stain; 3=heavy, dark stain).

Outcome measures

Measure	Crest® Regular Toothpaste n=47 Participants Crest® Cavity Protection Regular Toothpaste (Brushing Only)	11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse) n=45 Participants Crest® Cavity Protection followed by 1.5% Potassium Oxalate \& pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
Mean Stain Score for Facial Sites at 4 Weeks	0.063 units on a scale Standard Error 0.0314	0.058 units on a scale Standard Error 0.0342

SECONDARY outcome

Timeframe: 6 weeks

Population: Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.

The mean stain score (0-9) per participant was determined by multiplying the individual area and intensity scores from each region and summing them then dividing by the number of sites scored. The facial surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for area and intensity according to the following criteria. Stain area for mesial, gingival, and distal regions were scored on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain covers entire area) and for the body of tooth on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain outside pits/grooves, over 10% of surface affected). The intensity of yellow-brown stains occurring in each region was assessed on a 4-point ordinal scale (0=no stain; 3=heavy, dark stain).

Outcome measures

Measure	Crest® Regular Toothpaste n=46 Participants Crest® Cavity Protection Regular Toothpaste (Brushing Only)	11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse) n=44 Participants Crest® Cavity Protection followed by 1.5% Potassium Oxalate \& pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
Mean Stain Score for Facial Sites at 6 Weeks	0.118 units on a scale Standard Error 0.0399	0.140 units on a scale Standard Error 0.0427

SECONDARY outcome

Timeframe: 8 weeks

Population: Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.

The mean stain score (0-9) per participant was determined by multiplying the individual area and intensity scores from each region and summing them then dividing by the number of sites scored. The facial surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for area and intensity according to the following criteria. Stain area for mesial, gingival, and distal regions were scored on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain covers entire area) and for the body of tooth on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain outside pits/grooves, over 10% of surface affected). The intensity of yellow-brown stains occurring in each region was assessed on a 4-point ordinal scale (0=no stain; 3=heavy, dark stain).

Outcome measures

Measure	Crest® Regular Toothpaste n=46 Participants Crest® Cavity Protection Regular Toothpaste (Brushing Only)	11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse) n=41 Participants Crest® Cavity Protection followed by 1.5% Potassium Oxalate \& pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
Mean Stain Score for Facial Sites at 8 Weeks	0.097 units on a scale Standard Error 0.0576	0.319 units on a scale Standard Error 0.0642

SECONDARY outcome

Timeframe: 4 weeks

Population: Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.

The facial surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for intensity according to the following criteria. The intensity of yellow-brown stains occurring in each region is unrelated to the area covered with stained pellicle. All four regions were assessed on a 4-point ordinal scale as 0=no stain, 1=faint stain (can be seen with close examination), 2=moderate stain (clearly visible and aesthetically unacceptable), 3=heavy, dark stain (obvious and aesthetically unacceptable).

Outcome measures

Measure	Crest® Regular Toothpaste n=47 Participants Crest® Cavity Protection Regular Toothpaste (Brushing Only)	11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse) n=45 Participants Crest® Cavity Protection followed by 1.5% Potassium Oxalate \& pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
Mean Stain Intensity for Facial Sites at 4 Weeks	0.027 units on a scale Standard Error 0.0153	0.025 units on a scale Standard Error 0.0167

SECONDARY outcome

Timeframe: 6 weeks

Population: Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.

The facial surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for intensity according to the following criteria. The intensity of yellow-brown stains occurring in each region is unrelated to the area covered with stained pellicle. All four regions were assessed on a 4-point ordinal scale as 0=no stain, 1=faint stain (can be seen with close examination), 2=moderate stain (clearly visible and aesthetically unacceptable), 3=heavy, dark stain (obvious and aesthetically unacceptable).

Outcome measures

Measure	Crest® Regular Toothpaste n=46 Participants Crest® Cavity Protection Regular Toothpaste (Brushing Only)	11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse) n=44 Participants Crest® Cavity Protection followed by 1.5% Potassium Oxalate \& pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
Mean Stain Intensity for Facial Sites at 6 Weeks	0.054 units on a scale Standard Error 0.0192	0.065 units on a scale Standard Error 0.0206

SECONDARY outcome

Timeframe: 8 weeks

Population: Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.

The facial surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for intensity according to the following criteria. The intensity of yellow-brown stains occurring in each region is unrelated to the area covered with stained pellicle. All four regions were assessed on a 4-point ordinal scale as 0=no stain, 1=faint stain (can be seen with close examination), 2=moderate stain (clearly visible and aesthetically unacceptable), 3=heavy, dark stain (obvious and aesthetically unacceptable).

Outcome measures

Measure	Crest® Regular Toothpaste n=46 Participants Crest® Cavity Protection Regular Toothpaste (Brushing Only)	11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse) n=41 Participants Crest® Cavity Protection followed by 1.5% Potassium Oxalate \& pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
Mean Stain Intensity for Facial Sites at 8 Weeks	0.042 units on a scale Standard Error 0.0257	0.144 units on a scale Standard Error 0.0286

SECONDARY outcome

Timeframe: 4 weeks

Population: Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.

The facial surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for area according to the following criteria. Stain area for mesial, gingival, and distal regions were scored as 0=no stain present, natural tooth color; 1=thin line of stain, may be discontinuous; 2=thick line or band of stain; 3=stain covers entire area and for the body of tooth as 0=no stain present, natural tooth color, 1=stain limited to pits and grooves; 2=stain outside pits/grooves, up to 10% of surface affected; 3=stain outside pits/grooves, over 10% of surface affected.

Outcome measures

Measure	Crest® Regular Toothpaste n=47 Participants Crest® Cavity Protection Regular Toothpaste (Brushing Only)	11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse) n=45 Participants Crest® Cavity Protection followed by 1.5% Potassium Oxalate \& pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
Mean Stain Area for Facial Sites at 4 Weeks	0.032 units on a scale Standard Error 0.0147	0.033 units on a scale Standard Error 0.0160

SECONDARY outcome

Timeframe: 6 weeks

Population: Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.

The facial surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for area according to the following criteria. Stain area for mesial, gingival, and distal regions were scored as 0=no stain present, natural tooth color; 1=thin line of stain, may be discontinuous; 2=thick line or band of stain; 3=stain covers entire area and for the body of tooth as 0=no stain present, natural tooth color, 1=stain limited to pits and grooves; 2=stain outside pits/grooves, up to 10% of surface affected; 3=stain outside pits/grooves, over 10% of surface affected.

Outcome measures

Measure	Crest® Regular Toothpaste n=46 Participants Crest® Cavity Protection Regular Toothpaste (Brushing Only)	11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse) n=44 Participants Crest® Cavity Protection followed by 1.5% Potassium Oxalate \& pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
Mean Stain Area for Facial Sites at 6 Weeks	0.059 units on a scale Standard Error 0.0188	0.075 units on a scale Standard Error 0.0201

SECONDARY outcome

Timeframe: 8 weeks

Population: Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.

The facial surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for area according to the following criteria. Stain area for mesial, gingival, and distal regions were scored as 0=no stain present, natural tooth color; 1=thin line of stain, may be discontinuous; 2=thick line or band of stain; 3=stain covers entire area and for the body of tooth as 0=no stain present, natural tooth color, 1=stain limited to pits and grooves; 2=stain outside pits/grooves, up to 10% of surface affected; 3=stain outside pits/grooves, over 10% of surface affected.

Outcome measures

Measure	Crest® Regular Toothpaste n=46 Participants Crest® Cavity Protection Regular Toothpaste (Brushing Only)	11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse) n=41 Participants Crest® Cavity Protection followed by 1.5% Potassium Oxalate \& pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
Mean Stain Area for Facial Sites at 8 Weeks	0.047 units on a scale Standard Error 0.0281	0.160 units on a scale Standard Error 0.0313

SECONDARY outcome

Timeframe: 4 weeks

Population: Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.

The mean stain score (0-9) per participant was determined by multiplying the individual area and intensity scores from each region and summing them then dividing by the number of sites scored. The lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for area and intensity according to the following criteria. Stain area for mesial, gingival, and distal regions were scored on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain covers entire area) and for the body of tooth on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain outside pits/grooves, over 10% of surface affected). The intensity of yellow-brown stains occurring in each region was assessed on a 4-point ordinal scale (0=no stain; 3=heavy, dark stain).

Outcome measures

Measure	Crest® Regular Toothpaste n=47 Participants Crest® Cavity Protection Regular Toothpaste (Brushing Only)	11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse) n=45 Participants Crest® Cavity Protection followed by 1.5% Potassium Oxalate \& pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
Mean Stain Score for Lingual Sites at 4 Weeks	0.596 units on a scale Standard Error 0.0831	0.716 units on a scale Standard Error 0.0910

SECONDARY outcome

Timeframe: 6 weeks

Population: Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.

The mean stain score (0-9) per participant was determined by multiplying the individual area and intensity scores from each region and summing them then dividing by the number of sites scored. The lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for area and intensity according to the following criteria. Stain area for mesial, gingival, and distal regions were scored on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain covers entire area) and for the body of tooth on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain outside pits/grooves, over 10% of surface affected). The intensity of yellow-brown stains occurring in each region was assessed on a 4-point ordinal scale (0=no stain; 3=heavy, dark stain).

Outcome measures

Measure	Crest® Regular Toothpaste n=46 Participants Crest® Cavity Protection Regular Toothpaste (Brushing Only)	11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse) n=44 Participants Crest® Cavity Protection followed by 1.5% Potassium Oxalate \& pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
Mean Stain Score for Lingual Sites at 6 Weeks	0.586 units on a scale Standard Error 0.0949	1.106 units on a scale Standard Error 0.1020

SECONDARY outcome

Timeframe: 8 weeks

Population: Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.

The mean stain score (0-9) per participant was determined by multiplying the individual area and intensity scores from each region and summing them then dividing by the number of sites scored. The lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for area and intensity according to the following criteria. Stain area for mesial, gingival, and distal regions were scored on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain covers entire area) and for the body of tooth on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain outside pits/grooves, over 10% of surface affected). The intensity of yellow-brown stains occurring in each region was assessed on a 4-point ordinal scale (0=no stain; 3=heavy, dark stain).

Outcome measures

Measure	Crest® Regular Toothpaste n=46 Participants Crest® Cavity Protection Regular Toothpaste (Brushing Only)	11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse) n=41 Participants Crest® Cavity Protection followed by 1.5% Potassium Oxalate \& pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
Mean Stain Score for Lingual Sites at 8 Weeks	0.677 units on a scale Standard Error 0.1146	1.244 units on a scale Standard Error 0.1283

SECONDARY outcome

Timeframe: 4 weeks

Population: Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.

The lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for intensity according to the following criteria. The intensity of yellow-brown stains occurring in each region is unrelated to the area covered with stained pellicle. All four regions were assessed on a 4-point ordinal scale as 0=no stain, 1=faint stain (can be seen with close examination), 2=moderate stain (clearly visible and aesthetically unacceptable), 3=heavy, dark stain (obvious and aesthetically unacceptable).

Outcome measures

Measure	Crest® Regular Toothpaste n=47 Participants Crest® Cavity Protection Regular Toothpaste (Brushing Only)	11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse) n=45 Participants Crest® Cavity Protection followed by 1.5% Potassium Oxalate \& pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
Mean Stain Intensity for Lingual Sites at 4 Weeks	0.282 units on a scale Standard Error 0.0406	0.344 units on a scale Standard Error 0.0444

SECONDARY outcome

Timeframe: 6 weeks

Population: Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.

The lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for intensity according to the following criteria. The intensity of yellow-brown stains occurring in each region is unrelated to the area covered with stained pellicle. All four regions were assessed on a 4-point ordinal scale as 0=no stain, 1=faint stain (can be seen with close examination), 2=moderate stain (clearly visible and aesthetically unacceptable), 3=heavy, dark stain (obvious and aesthetically unacceptable).

Outcome measures

Measure	Crest® Regular Toothpaste n=46 Participants Crest® Cavity Protection Regular Toothpaste (Brushing Only)	11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse) n=44 Participants Crest® Cavity Protection followed by 1.5% Potassium Oxalate \& pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
Mean Stain Intensity for Lingual Sites at 6 Weeks	0.279 units on a scale Standard Error 0.0467	0.541 units on a scale Standard Error 0.0501

SECONDARY outcome

Timeframe: 8 weeks

Population: Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.

The lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for intensity according to the following criteria. The intensity of yellow-brown stains occurring in each region is unrelated to the area covered with stained pellicle. All four regions were assessed on a 4-point ordinal scale as 0=no stain, 1=faint stain (can be seen with close examination), 2=moderate stain (clearly visible and aesthetically unacceptable), 3=heavy, dark stain (obvious and aesthetically unacceptable).

Outcome measures

Measure	Crest® Regular Toothpaste n=46 Participants Crest® Cavity Protection Regular Toothpaste (Brushing Only)	11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse) n=41 Participants Crest® Cavity Protection followed by 1.5% Potassium Oxalate \& pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
Mean Stain Intensity for Lingual Sites at 8 Weeks	0.314 units on a scale Standard Error 0.0549	0.596 units on a scale Standard Error 0.0614

SECONDARY outcome

Timeframe: 4 weeks

Population: Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.

The lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for area according to the following criteria. Stain area for mesial, gingival, and distal regions were scored as 0=no stain present, natural tooth color; 1=thin line of stain, may be discontinuous; 2=thick line or band of stain; 3=stain covers entire area and for the body of tooth as 0=no stain present, natural tooth color, 1=stain limited to pits and grooves; 2=stain outside pits/grooves, up to 10% of surface affected; 3=stain outside pits/grooves, over 10% of surface affected.

Outcome measures

Measure	Crest® Regular Toothpaste n=47 Participants Crest® Cavity Protection Regular Toothpaste (Brushing Only)	11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse) n=45 Participants Crest® Cavity Protection followed by 1.5% Potassium Oxalate \& pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
Mean Stain Area for Lingual Sites at 4 Weeks	0.293 units on a scale Standard Error 0.0409	0.359 units on a scale Standard Error 0.0448

SECONDARY outcome

Timeframe: 6 weeks

Population: Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.

The lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for area according to the following criteria. Stain area for mesial, gingival, and distal regions were scored as 0=no stain present, natural tooth color; 1=thin line of stain, may be discontinuous; 2=thick line or band of stain; 3=stain covers entire area and for the body of tooth as 0=no stain present, natural tooth color, 1=stain limited to pits and grooves; 2=stain outside pits/grooves, up to 10% of surface affected; 3=stain outside pits/grooves, over 10% of surface affected.

Outcome measures

Measure	Crest® Regular Toothpaste n=46 Participants Crest® Cavity Protection Regular Toothpaste (Brushing Only)	11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse) n=44 Participants Crest® Cavity Protection followed by 1.5% Potassium Oxalate \& pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
Mean Stain Area for Lingual Sites at 6 Weeks	0.277 units on a scale Standard Error 0.0460	0.533 units on a scale Standard Error 0.0495

SECONDARY outcome

Timeframe: 8 weeks

Population: Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.

The lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for area according to the following criteria. Stain area for mesial, gingival, and distal regions were scored as 0=no stain present, natural tooth color; 1=thin line of stain, may be discontinuous; 2=thick line or band of stain; 3=stain covers entire area and for the body of tooth as 0=no stain present, natural tooth color, 1=stain limited to pits and grooves; 2=stain outside pits/grooves, up to 10% of surface affected; 3=stain outside pits/grooves, over 10% of surface affected.

Outcome measures

Measure	Crest® Regular Toothpaste n=46 Participants Crest® Cavity Protection Regular Toothpaste (Brushing Only)	11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse) n=41 Participants Crest® Cavity Protection followed by 1.5% Potassium Oxalate \& pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
Mean Stain Area for Lingual Sites at 8 Weeks	0.325 units on a scale Standard Error 0.0560	0.598 units on a scale Standard Error 0.0628

Adverse Events

Crest® Regular Toothpaste

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Crest® Regular Toothpaste n=48 participants at risk Crest® Cavity Protection Regular Toothpaste (Brushing Only)	11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse) n=48 participants at risk Crest® Cavity Protection followed by 1.5% Potassium Oxalate \& pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
Infections and infestations Nasopharyngitis	6.2% 3/48 • Week 8, +30 days for serious adverse events. Adverse events were systematically collected at each study visit through Visit 4 (Week 8). Serious adverse events were reported through 30 days after product use. Spontaneously reported adverse events collected outside of the regularly scheduled visits were also recorded.	4.2% 2/48 • Week 8, +30 days for serious adverse events. Adverse events were systematically collected at each study visit through Visit 4 (Week 8). Serious adverse events were reported through 30 days after product use. Spontaneously reported adverse events collected outside of the regularly scheduled visits were also recorded.

Additional Information

Michael Lynch, DMD, PhD/Study Director

Johnson & Johnson Consumer and Personal Products Worldwide

Phone: 908-433-6423 USA EST

Email: mlynch23@its.jnj.com

Results disclosure agreements

• Principal investigator is a sponsor employee Principal investigator agreed not to publish the study results without prior sponsor approval.
• Publication restrictions are in place

Restriction type: OTHER