Trial Outcomes & Findings for Clinical Efficacy of 10% Arginine Bicarbonate Prophylaxis Paste (NCT NCT01072188)

Results Overview

Units on a scale: Measured with an electronic force sensing probe (Yeaple Probe): 10, 20, 30, 40, up to 50 grams of force are applied to hypersensitive tooth until pain elicited. Grams of force needed to elicit pain are recorded as hypersensitivity score for the tooth. The higher the score, the higher the hypersensitivity.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

45 participants

Primary outcome timeframe

Immediately after product application

Results posted on

2011-06-14

Participant Flow

Participant milestones

Participant milestones
Measure	ProClude Prophylaxis Paste-A Arginine Bicarbonate prophy paste (experimental).	Nupro-M Prophylaxis Paste-B Control prophy paste (Fluoride free).
Overall Study STARTED	22	23
Overall Study COMPLETED	22	23
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Clinical Efficacy of 10% Arginine Bicarbonate Prophylaxis Paste

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	ProClude Prophylaxis Paste-A n=22 Participants Arginine Bicarbonate prophy paste (experimental).	Nupro-M Prophylaxis Paste-B n=23 Participants Control prophy paste (Fluoride free).	Total n=45 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	21 Participants n=5 Participants	23 Participants n=7 Participants	44 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Age Continuous	44.13 years STANDARD_DEVIATION 7.78 • n=5 Participants	45.91 years STANDARD_DEVIATION 11.41 • n=7 Participants	45 years STANDARD_DEVIATION 9.66 • n=5 Participants
Sex: Female, Male Female	16 Participants n=5 Participants	17 Participants n=7 Participants	33 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	6 Participants n=7 Participants	12 Participants n=5 Participants
Region of Enrollment United States	22 participants n=5 Participants	23 participants n=7 Participants	45 participants n=5 Participants

PRIMARY outcome

Timeframe: Immediately after product application

Units on a scale: Measured with an electronic force sensing probe (Yeaple Probe): 10, 20, 30, 40, up to 50 grams of force are applied to hypersensitive tooth until pain elicited. Grams of force needed to elicit pain are recorded as hypersensitivity score for the tooth. The higher the score, the higher the hypersensitivity.

Outcome measures

Outcome measures
Measure	ProClude Prophylaxis Paste-A n=22 Participants Arginine Bicarbonate prophy paste (experimental).	Nupro-M Prophylaxis Paste-B n=23 Participants Control prophy paste (Fluoride free).
Hypersensitivity to Touch (Tactile)	42.2 Units on a scale Standard Deviation 9.25	20.1 Units on a scale Standard Deviation 9.25

PRIMARY outcome

Timeframe: Immediately after product application

Units on a scale using Schiff Cold Air Sensitivity Scale. Response to a constant (duration, pressure, temperature, distance from target) jet of air applied to a hypersensitive tooth. According to this analog scale hypersensitivity scores for the stimulated tooth is 0, 1, 2 or 3(The lower the score, the lower the hypersensitivity). 0=No subject response to stimulus, 1=responds but will continue, 2=responds and moves or requests discontinuation, 3=Painful response to stimulus, discontinuation requested.

Outcome measures

Outcome measures
Measure	ProClude Prophylaxis Paste-A n=22 Participants Arginine Bicarbonate prophy paste (experimental).	Nupro-M Prophylaxis Paste-B n=23 Participants Control prophy paste (Fluoride free).
Air Blast	1.26 Units on a scale Standard Deviation 0.58	2.17 Units on a scale Standard Deviation 0.58

Adverse Events

ProClude Prophylaxis Paste-A

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Nupro-M Prophylaxis Paste-B

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

William DeVizio - DMD

Colgate Palmolive

Phone: 732-878-7901

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60