Trial Outcomes & Findings for Clinical Evaluation of the Efficacy of a Marketed Dentifrice on Plaque and Gingivitis (NCT NCT03214406)

Last Updated: 2021-05-11

Results Overview

change in score as measured by Gingival Index (0=absence of inflammation, 1=mild inflammation: slight change in color, little change in texture of any portion of but not the entire marginal or papillary gingival unit, 2=mild inflammation: slight change in color, little change in texture to entire marginal or papillary gingival unit, 3=moderate inflammation: glazing, redness, edema and/or hypertrophy of the marginal or papillary gingival unit, 4=severe inflammation: marked redness, edema and/or hypertrophy of the marginal or papillary gingival unit, spontaneous bleeding, congestion, or ulceration. The scale ranges from 0-4.

Recruitment status

COMPLETED

Study phase

Target enrollment

181 participants

Primary outcome timeframe

16 weeks

Results posted on

2021-05-11

Participant Flow

Participant milestones

Participant milestones
Measure	Arm & Hammer Advance White Brilliant Sparkle (Test Product) 2X daily brushing for 12 weeks with Arm \& Hammer Advance White Brilliant Sparkle (Test product) Arm \& Hammer Advance White Brilliant Sparkle (Test product): 20% sodium bicarbonate	Crest Cavity Protection Regular Toothpaste (Negative Control) 2X daily brushing for 12 weeks with Crest Cavity Protection Regular Toothpaste (Negative Control) Crest Cavity Protection Regular Toothpaste (Negative Control): Negative control
Overall Study STARTED	88	93
Overall Study COMPLETED	78	78
Overall Study NOT COMPLETED	10	15

Reasons for withdrawal

Reasons for withdrawal
Measure	Arm & Hammer Advance White Brilliant Sparkle (Test Product) 2X daily brushing for 12 weeks with Arm \& Hammer Advance White Brilliant Sparkle (Test product) Arm \& Hammer Advance White Brilliant Sparkle (Test product): 20% sodium bicarbonate	Crest Cavity Protection Regular Toothpaste (Negative Control) 2X daily brushing for 12 weeks with Crest Cavity Protection Regular Toothpaste (Negative Control) Crest Cavity Protection Regular Toothpaste (Negative Control): Negative control
Overall Study did not meet enrollment criteria	9	13
Overall Study Withdrawal by Subject	1	0
Overall Study Lost to Follow-up	0	2

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm & Hammer Advance White Brilliant Sparkle (Test Product) n=78 Participants 2X daily brushing for 12 weeks with Arm \& Hammer Advance White Brilliant Sparkle (Test product) Arm \& Hammer Advance White Brilliant Sparkle (Test product): 20% sodium bicarbonate	Crest Cavity Protection Regular Toothpaste (Negative Control) n=78 Participants 2X daily brushing for 12 weeks with Crest Cavity Protection Regular Toothpaste (Negative Control) Crest Cavity Protection Regular Toothpaste (Negative Control): Negative control	Total n=156 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=78 Participants	0 Participants n=78 Participants	0 Participants n=156 Participants
Age, Categorical Between 18 and 65 years	78 Participants n=78 Participants	78 Participants n=78 Participants	156 Participants n=156 Participants
Age, Categorical >=65 years	0 Participants n=78 Participants	0 Participants n=78 Participants	0 Participants n=156 Participants
Sex: Female, Male Female	56 Participants n=78 Participants	51 Participants n=78 Participants	107 Participants n=156 Participants
Sex: Female, Male Male	22 Participants n=78 Participants	27 Participants n=78 Participants	49 Participants n=156 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Gingvial Efficacy	2.039 units on a scale STANDARD_DEVIATION .053 • n=78 Participants	2.039 units on a scale STANDARD_DEVIATION .057 • n=78 Participants	2.039 units on a scale STANDARD_DEVIATION .055 • n=156 Participants
Gingival Bleeding Efficacy	.228 units on a scale STANDARD_DEVIATION .046 • n=78 Participants	.230 units on a scale STANDARD_DEVIATION .044 • n=78 Participants	.229 units on a scale STANDARD_DEVIATION .045 • n=156 Participants
Plaque Efficacy	2.575 units on a scale STANDARD_DEVIATION .295 • n=78 Participants	2.534 units on a scale STANDARD_DEVIATION .248 • n=78 Participants	2.555 units on a scale STANDARD_DEVIATION .272 • n=156 Participants

PRIMARY outcome

Timeframe: 16 weeks

Outcome measures

Outcome measures
Measure	Arm & Hammer Advance White Brilliant Sparkle (Test Product) n=78 Participants 2X daily brushing for 12 weeks with Arm \& Hammer Advance White Brilliant Sparkle (Test product) Arm \& Hammer Advance White Brilliant Sparkle (Test product): 20% sodium bicarbonate	Crest Cavity Protection Regular Toothpaste (Negative Control) n=78 Participants 2X daily brushing for 12 weeks with Crest Cavity Protection Regular Toothpaste (Negative Control) Crest Cavity Protection Regular Toothpaste (Negative Control): Negative control
Within-Treatment Whole-Mouth Differences (vs Baseline) - Gingival Efficacy 4 weeks	.230 units on a scale Standard Deviation .105	.155 units on a scale Standard Deviation .123
Within-Treatment Whole-Mouth Differences (vs Baseline) - Gingival Efficacy 8 weeks	.3701 units on a scale Standard Deviation .130	.205 units on a scale Standard Deviation .077
Within-Treatment Whole-Mouth Differences (vs Baseline) - Gingival Efficacy 12 weeks	.444 units on a scale Standard Deviation .139	.214 units on a scale Standard Deviation .110
Within-Treatment Whole-Mouth Differences (vs Baseline) - Gingival Efficacy 16 weeks	.330 units on a scale Standard Deviation .118	.157 units on a scale Standard Deviation .084

PRIMARY outcome

Timeframe: 16 weeks

change in score as measured by Gingival Bleeding Index (0=absence of bleeding after 30 seconds, 1= bleeding observed after 30 seconds, 2= bleeding occurs instantly). The scale ranges from 0-2.

Outcome measures

Outcome measures
Measure	Arm & Hammer Advance White Brilliant Sparkle (Test Product) n=78 Participants 2X daily brushing for 12 weeks with Arm \& Hammer Advance White Brilliant Sparkle (Test product) Arm \& Hammer Advance White Brilliant Sparkle (Test product): 20% sodium bicarbonate	Crest Cavity Protection Regular Toothpaste (Negative Control) n=78 Participants 2X daily brushing for 12 weeks with Crest Cavity Protection Regular Toothpaste (Negative Control) Crest Cavity Protection Regular Toothpaste (Negative Control): Negative control
Within-Treatment Whole-Mouth Differences (vs Baseline) Gingival Bleeding Efficacy 4 weeks	.134 units on a scale Standard Deviation .055	.119 units on a scale Standard Deviation .056
Within-Treatment Whole-Mouth Differences (vs Baseline) Gingival Bleeding Efficacy 8 weeks	.162 units on a scale Standard Deviation .042	.145 units on a scale Standard Deviation .039
Within-Treatment Whole-Mouth Differences (vs Baseline) Gingival Bleeding Efficacy 12 weeks	.190 units on a scale Standard Deviation .045	.162 units on a scale Standard Deviation .056
Within-Treatment Whole-Mouth Differences (vs Baseline) Gingival Bleeding Efficacy 16 weeks	.180 units on a scale Standard Deviation .043	.144 units on a scale Standard Deviation .056

PRIMARY outcome

Timeframe: 16 weeks

change in score as measured by Plaque Index (0=no visible plaque, 1=separate flecks of plaque at the cervical margin of the tooth, 2=a thin, continuous band of plaque (up to 1mm wide) at the cervical margin, 3= a band of plaque wider than 1 mm but covering less than one-third of the crown, 4=plaque covering at least one-third but less than two-thirds of the crown, 5= plaque covering two-thirds or more of the crown. The scale ranges from 0-5.

Outcome measures

Outcome measures
Measure	Arm & Hammer Advance White Brilliant Sparkle (Test Product) n=78 Participants 2X daily brushing for 12 weeks with Arm \& Hammer Advance White Brilliant Sparkle (Test product) Arm \& Hammer Advance White Brilliant Sparkle (Test product): 20% sodium bicarbonate	Crest Cavity Protection Regular Toothpaste (Negative Control) n=78 Participants 2X daily brushing for 12 weeks with Crest Cavity Protection Regular Toothpaste (Negative Control) Crest Cavity Protection Regular Toothpaste (Negative Control): Negative control
Within-Treatment Whole-Mouth Differences (vs Baseline) - Plaque Efficacy 4 weeks	.648 units on a scale Standard Deviation .327	.468 units on a scale Standard Deviation .264
Within-Treatment Whole-Mouth Differences (vs Baseline) - Plaque Efficacy 8 weeks	.776 units on a scale Standard Deviation .369	.574 units on a scale Standard Deviation .283
Within-Treatment Whole-Mouth Differences (vs Baseline) - Plaque Efficacy 12 weeks	.765 units on a scale Standard Deviation .295	.533 units on a scale Standard Deviation .332
Within-Treatment Whole-Mouth Differences (vs Baseline) - Plaque Efficacy 16 weeks	.275 units on a scale Standard Deviation .378	.275 units on a scale Standard Deviation .378

Adverse Events

Arm & Hammer Advance White Brilliant Sparkle (Test Product)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Crest Cavity Protection Regular Toothpaste (Negative Control)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Annahita Ghassemi

Church & Dwight Co., Inc

Phone: 6098061200

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Confidentiality agreement in place with Investigator.
Publication restrictions are in place

Restriction type: OTHER