Trial Outcomes & Findings for A Clinical Trial to Test the Effect of a Marketed Mouth Rinse on Stain Removal (NCT NCT02151058)

NCT ID: NCT02151058

Last Updated: 2015-06-01

Results Overview

Tooth stain surface and stain intensity were assessed by using scores on the Lobene Stain Index (two part visual scale), scored 0 - 3. Where 0 = no stain, 1 = light stain, 2 = moderate stain and 3 = heavy stain. The second part of the scale examined the surface of the tooth on a scale of 0-3, where 0= no stain, 1 = covering up to 1/3 of the region, 2 = covering \> 1/3 to 2/3 of the region and 3 = covering \> 2/3 of the region. The mean composite score (0-9) was determined by multiplying the individual tooth stain surface and stain intensity scores and summing then dividing by the number of regions scored for the subject (or tooth).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

227 participants

Primary outcome timeframe

15 Days

Results posted on

2015-06-01

Participant Flow

Participant milestones

Participant milestones
Measure	Negative Control Colgate® Regular Cavity Protection Toothpaste (Brushing Only)	Crest 3D Colgate® Regular Cavity Protection Toothpaste followed by Crest® 3D Whitening Rinse (Brushing followed by Mouth Rinse)	Investigative Mouth Rinse Colgate® Regular Cavity Protection Toothpaste followed by Investigative Hydrogen Peroxide/Sodium Fluoride Mouth Rinse (Brushing followed by Mouth Rinse)
Overall Study STARTED	45	91	91
Overall Study COMPLETED	43	90	86
Overall Study NOT COMPLETED	2	1	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Negative Control Colgate® Regular Cavity Protection Toothpaste (Brushing Only)	Crest 3D Colgate® Regular Cavity Protection Toothpaste followed by Crest® 3D Whitening Rinse (Brushing followed by Mouth Rinse)	Investigative Mouth Rinse Colgate® Regular Cavity Protection Toothpaste followed by Investigative Hydrogen Peroxide/Sodium Fluoride Mouth Rinse (Brushing followed by Mouth Rinse)
Overall Study Withdrawal by Subject	1	1	3
Overall Study Lost to Follow-up	1	0	2

Baseline Characteristics

A Clinical Trial to Test the Effect of a Marketed Mouth Rinse on Stain Removal

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Negative Control n=45 Participants Colgate® Regular Cavity Protection Toothpaste (Brushing Only)	Crest 3D n=91 Participants Colgate® Regular Cavity Protection Toothpaste followed by Crest® 3D Whitening Rinse (Brushing followed by Mouth Rinse)	Investigative Mouth Rinse n=91 Participants Colgate® Regular Cavity Protection Toothpaste followed by Investigative Hydrogen Peroxide/Sodium Fluoride Mouth Rinse (Brushing followed by Mouth Rinse)	Total n=227 Participants Total of all reporting groups
Age, Continuous	44.2 years STANDARD_DEVIATION 12.57 • n=5 Participants	43.3 years STANDARD_DEVIATION 12.15 • n=7 Participants	44.0 years STANDARD_DEVIATION 12.40 • n=5 Participants	43.8 years STANDARD_DEVIATION 12.29 • n=4 Participants
Sex: Female, Male Female	35 Participants n=5 Participants	60 Participants n=7 Participants	69 Participants n=5 Participants	164 Participants n=4 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	31 Participants n=7 Participants	22 Participants n=5 Participants	63 Participants n=4 Participants
Region of Enrollment USA	45 participants n=5 Participants	91 participants n=7 Participants	91 participants n=5 Participants	227 participants n=4 Participants

PRIMARY outcome

Timeframe: 15 Days

Population: Analysis was based on the Full Analysis Set, which included all randomized subjects who used study product and had baseline and at least one post-baseline efficacy assessment.

Tooth stain surface and stain intensity were assessed by using scores on the Lobene Stain Index (two part visual scale), scored 0 - 3. Where 0 = no stain, 1 = light stain, 2 = moderate stain and 3 = heavy stain. The second part of the scale examined the surface of the tooth on a scale of 0-3, where 0= no stain, 1 = covering up to 1/3 of the region, 2 = covering \> 1/3 to 2/3 of the region and 3 = covering \> 2/3 of the region. The mean composite score (0-9) was determined by multiplying the individual tooth stain surface and stain intensity scores and summing then dividing by the number of regions scored for the subject (or tooth).

Outcome measures

Outcome measures
Measure	Negative Control n=43 Participants Colgate® Regular Cavity Protection Toothpaste (Brushing Only)	Crest 3D n=90 Participants Colgate® Regular Cavity Protection Toothpaste followed by Crest® 3D Whitening Rinse (Brushing followed by Mouth Rinse)	Investigative Mouth Rinse n=86 Participants Colgate® Regular Cavity Protection Toothpaste followed by Investigative Hydrogen Peroxide/Sodium Fluoride Mouth Rinse (Brushing followed by Mouth Rinse)
Lobene Stain Index Composite Score at Day 15	2.568 units on a scale Standard Error 0.0821	1.909 units on a scale Standard Error 0.0568	1.575 units on a scale Standard Error 0.0580

SECONDARY outcome

Timeframe: 4 Days

Population: Analysis was based on the Full Analysis Set, which included all randomized subjects who used study product and had baseline and at least one post-baseline efficacy assessment.

Tooth stain surface and stain intensity were assessed by using scores on the Lobene Stain Index (two part visual scale), scored 0 - 3. Where 0 = no stain, 1 = light stain, 2 = moderate stain and 3 = heavy stain. The second part of the scale examined the surface of the tooth on a scale of 0-3, where 0= no stain, 1 = covering up to 1/3 of the region, 2 = covering \> 1/3 to 2/3 of the region and 3 = covering \> 2/3 of the region. The mean composite score (0-9) was determined by multiplying the individual tooth stain surface and stain intensity scores and summing then dividing by the number of regions scored for the subject (or tooth).

Outcome measures

Outcome measures
Measure	Negative Control n=43 Participants Colgate® Regular Cavity Protection Toothpaste (Brushing Only)	Crest 3D n=90 Participants Colgate® Regular Cavity Protection Toothpaste followed by Crest® 3D Whitening Rinse (Brushing followed by Mouth Rinse)	Investigative Mouth Rinse n=88 Participants Colgate® Regular Cavity Protection Toothpaste followed by Investigative Hydrogen Peroxide/Sodium Fluoride Mouth Rinse (Brushing followed by Mouth Rinse)
Lobene Stain Index Composite Score at Day 4	2.527 units on a scale Standard Error 0.0665	2.242 units on a scale Standard Error 0.0459	2.200 units on a scale Standard Error 0.0464

SECONDARY outcome

Timeframe: 8 Days

Population: Analysis was based on the Full Analysis Set, which included all randomized subjects who used study product and had baseline and at least one post-baseline efficacy assessment.

Tooth stain surface and stain intensity were assessed by using scores on the Lobene Stain Index (two part visual scale), scored 0 - 3. Where 0 = no stain, 1 = light stain, 2 = moderate stain and 3 = heavy stain. The second part of the scale examined the surface of the tooth on a scale of 0-3, where 0= no stain, 1 = covering up to 1/3 of the region, 2 = covering \> 1/3 to 2/3 of the region and 3 = covering \> 2/3 of the region. The mean composite score (0-9) was determined by multiplying the individual tooth stain surface and stain intensity scores and summing then dividing by the number of regions scored for the subject (or tooth).

Outcome measures

Outcome measures
Measure	Negative Control n=43 Participants Colgate® Regular Cavity Protection Toothpaste (Brushing Only)	Crest 3D n=90 Participants Colgate® Regular Cavity Protection Toothpaste followed by Crest® 3D Whitening Rinse (Brushing followed by Mouth Rinse)	Investigative Mouth Rinse n=87 Participants Colgate® Regular Cavity Protection Toothpaste followed by Investigative Hydrogen Peroxide/Sodium Fluoride Mouth Rinse (Brushing followed by Mouth Rinse)
Lobene Stain Index Composite Score at Day 8	2.536 units on a scale Standard Error 0.0798	2.023 units on a scale Standard Error 0.0551	1.852 units on a scale Standard Error 0.0561

SECONDARY outcome

Timeframe: 4 Days

Population: Analysis was based on the Full Analysis Set, which included all randomized subjects who used study product and had baseline and at least one post-baseline efficacy assessment.

Tooth stain surface was assessed by using scores on the Lobene Stain Index scored 0 - 3, where 0= no stain, 1 = covering up to 1/3 of the region, 2 = covering \> 1/3 to 2/3 of the region, and 3 = covering \> 2/3 of the region.

Outcome measures

Outcome measures
Measure	Negative Control n=43 Participants Colgate® Regular Cavity Protection Toothpaste (Brushing Only)	Crest 3D n=90 Participants Colgate® Regular Cavity Protection Toothpaste followed by Crest® 3D Whitening Rinse (Brushing followed by Mouth Rinse)	Investigative Mouth Rinse n=88 Participants Colgate® Regular Cavity Protection Toothpaste followed by Investigative Hydrogen Peroxide/Sodium Fluoride Mouth Rinse (Brushing followed by Mouth Rinse)
Lobene Stain Index Area Scores at Day 4	1.621 units on a scale Standard Error 0.0304	1.538 units on a scale Standard Error 0.0209	1.502 units on a scale Standard Error 0.0212

SECONDARY outcome

Timeframe: 8 Days

Population: Analysis was based on the Full Analysis Set, which included all randomized subjects who used study product and had baseline and at least one post-baseline efficacy assessment.

Tooth stain surface was assessed by using scores on the Lobene Stain Index scored 0 - 3, where 0= no stain, 1 = covering up to 1/3 of the region, 2 = covering \> 1/3 to 2/3 of the region, and 3 = covering \> 2/3 of the region.

Outcome measures

Outcome measures
Measure	Negative Control n=43 Participants Colgate® Regular Cavity Protection Toothpaste (Brushing Only)	Crest 3D n=90 Participants Colgate® Regular Cavity Protection Toothpaste followed by Crest® 3D Whitening Rinse (Brushing followed by Mouth Rinse)	Investigative Mouth Rinse n=87 Participants Colgate® Regular Cavity Protection Toothpaste followed by Investigative Hydrogen Peroxide/Sodium Fluoride Mouth Rinse (Brushing followed by Mouth Rinse)
Lobene Stain Index Area Scores at Day 8	1.615 units on a scale Standard Error 0.0468	1.439 units on a scale Standard Error 0.0321	1.265 units on a scale Standard Error 0.0327

SECONDARY outcome

Timeframe: 15 Days

Population: Analysis was based on the Full Analysis Set, which included all randomized subjects who used study product and had baseline and at least one post-baseline efficacy assessment.

Tooth stain surface was assessed by using scores on the Lobene Stain Index scored 0 - 3, where 0= no stain, 1 = covering up to 1/3 of the region, 2 = covering \> 1/3 to 2/3 of the region, and 3 = covering \> 2/3 of the region.

Outcome measures

Outcome measures
Measure	Negative Control n=43 Participants Colgate® Regular Cavity Protection Toothpaste (Brushing Only)	Crest 3D n=90 Participants Colgate® Regular Cavity Protection Toothpaste followed by Crest® 3D Whitening Rinse (Brushing followed by Mouth Rinse)	Investigative Mouth Rinse n=86 Participants Colgate® Regular Cavity Protection Toothpaste followed by Investigative Hydrogen Peroxide/Sodium Fluoride Mouth Rinse (Brushing followed by Mouth Rinse)
Lobene Stain Index Area Scores at Day 15	1.629 units on a scale Standard Error 0.0520	1.382 units on a scale Standard Error 0.0357	1.131 units on a scale Standard Error 0.0366

SECONDARY outcome

Timeframe: 4 Days

Population: Analysis was based on the Full Analysis Set, which included all randomized subjects who used study product and had baseline and at least one post-baseline efficacy assessment.

Tooth stain surface was assessed by using scores on the Lobene Stain Index scored 0 - 3, where 0= no stain, 1 = light stain, 2 = moderate stain, and 3 = heavy stain.

Outcome measures

Outcome measures
Measure	Negative Control n=43 Participants Colgate® Regular Cavity Protection Toothpaste (Brushing Only)	Crest 3D n=90 Participants Colgate® Regular Cavity Protection Toothpaste followed by Crest® 3D Whitening Rinse (Brushing followed by Mouth Rinse)	Investigative Mouth Rinse n=88 Participants Colgate® Regular Cavity Protection Toothpaste followed by Investigative Hydrogen Peroxide/Sodium Fluoride Mouth Rinse (Brushing followed by Mouth Rinse)
Lobene Stain Index Intensity Scores at Day 4	1.651 units on a scale Standard Error 0.0306	1.527 units on a scale Standard Error 0.0211	1.483 units on a scale Standard Error 0.0214

SECONDARY outcome

Timeframe: 8 Days

Population: Analysis was based on the Full Analysis Set, which included all randomized subjects who used study product and had baseline and at least one post-baseline efficacy assessment.

Tooth stain surface was assessed by using scores on the Lobene Stain Index scored 0 - 3, where 0= no stain, 1 = light stain, 2 = moderate stain, and 3 = heavy stain.

Outcome measures

Outcome measures
Measure	Negative Control n=43 Participants Colgate® Regular Cavity Protection Toothpaste (Brushing Only)	Crest 3D n=90 Participants Colgate® Regular Cavity Protection Toothpaste followed by Crest® 3D Whitening Rinse (Brushing followed by Mouth Rinse)	Investigative Mouth Rinse n=87 Participants Colgate® Regular Cavity Protection Toothpaste followed by Investigative Hydrogen Peroxide/Sodium Fluoride Mouth Rinse (Brushing followed by Mouth Rinse)
Lobene Stain Index Intensity Scores at Day 8	1.668 units on a scale Standard Error 0.0409	1.438 units on a scale Standard Error 0.0283	1.355 units on a scale Standard Error 0.0288

SECONDARY outcome

Timeframe: 15 Days

Population: Analysis was based on the Full Analysis Set, which included all randomized subjects who used study product and had baseline and at least one post-baseline efficacy assessment.

Tooth stain surface was assessed by using scores on the Lobene Stain Index scored 0 - 3, where 0= no stain, 1 = light stain, 2 = moderate stain, and 3 = heavy stain.

Outcome measures

Outcome measures
Measure	Negative Control n=43 Participants Colgate® Regular Cavity Protection Toothpaste (Brushing Only)	Crest 3D n=90 Participants Colgate® Regular Cavity Protection Toothpaste followed by Crest® 3D Whitening Rinse (Brushing followed by Mouth Rinse)	Investigative Mouth Rinse n=86 Participants Colgate® Regular Cavity Protection Toothpaste followed by Investigative Hydrogen Peroxide/Sodium Fluoride Mouth Rinse (Brushing followed by Mouth Rinse)
Lobene Stain Index Intensity Scores at Day 15	1.671 units on a scale Standard Error 0.0447	1.396 units on a scale Standard Error 0.0309	1.206 units on a scale Standard Error 0.0316

Adverse Events

Negative Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Crest 3D

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Investigative Mouth Rinse

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

Michael Lynch, DMD, PhD/Study Director

Johnson & Johnson Consumer and Personal Products Worldwide

Phone: 908-433-6423 USA EST

Email: [email protected]

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