Trial Outcomes & Findings for NUPRO(r) Sensodyne Prophylaxis Paste With NovaMin(r)Sensitivity Relief Study (NCT NCT01610167)

Results Overview

Assessment of sensitivity via tactile stimulation immediately after treatment. Tactile sensitivity measured using a Yeaple probe recording tactile pressure in grams before nerve stimulation. Point of nerve stimulation identified by patient with a "yes" response as pressure is increased in 10 gram increments. Tactile sensitivity is reported as the change from baseline after treatment.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

151 participants

Primary outcome timeframe

Immediately after treatment.

Results posted on

2013-10-14

Participant Flow

327 subjects queried from Investigator database following IRB apprvoal on 14-Sept.-2011. 199 of the queried subjects were consented and screened. 161 subjects were accepted at screening and appointed for baseline visit 2 weeks later. 159 subjects were evaluated at the baseline exam and 151 subjects were randomized and enrolled into the study.

10 subjects were lost following screening and at baseline assessment. 5 of the 10 were disqualified due to insufficient tactile response, 3 due to lack of evaproative hypersensitivity, and 2 had scheduling conflicts.

Participant milestones

Participant milestones
Measure	NUPRO Sensodyne Prophy Paste w/ Novamin NUPRO Sensodyne Prophy Paste with Novamin without fluoride. : Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth.	NUPRO Sensodyne Prophy Paste w/ Novamin(r) w/ Fluoride. NUPRO Sensodyne Prophy Paste with Novamin with fluoride. : Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth.	NUPRO(r) Classic Prophy Paste NUPRO Classic Prophy Paste : Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth.
Overall Study STARTED	52	49	50
Overall Study COMPLETED	52	49	48
Overall Study NOT COMPLETED	0	0	2

Reasons for withdrawal

Reasons for withdrawal
Measure	NUPRO Sensodyne Prophy Paste w/ Novamin NUPRO Sensodyne Prophy Paste with Novamin without fluoride. : Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth.	NUPRO Sensodyne Prophy Paste w/ Novamin(r) w/ Fluoride. NUPRO Sensodyne Prophy Paste with Novamin with fluoride. : Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth.	NUPRO(r) Classic Prophy Paste NUPRO Classic Prophy Paste : Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth.
Overall Study Scheduling conflict.	0	0	2

Baseline Characteristics

NUPRO(r) Sensodyne Prophylaxis Paste With NovaMin(r)Sensitivity Relief Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	NUPRO Sensodyne Prophy Paste w/ Novamin n=52 Participants NUPRO Sensodyne Prophy Paste with Novamin without fluoride. : Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth.	NUPRO Sensodyne Prophy Paste w/ Novamin(r) w/ Fluoride. n=49 Participants NUPRO Sensodyne Prophy Paste with Novamin with fluoride. : Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth.	NUPRO(r) Classic Prophy Paste n=50 Participants NUPRO Classic Prophy Paste : Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth.	Total n=151 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	52 Participants n=5 Participants	49 Participants n=7 Participants	49 Participants n=5 Participants	150 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age Continuous	41.31 years STANDARD_DEVIATION 11.10 • n=5 Participants	41.55 years STANDARD_DEVIATION 10.70 • n=7 Participants	42.10 years STANDARD_DEVIATION 10.31 • n=5 Participants	41.65 years STANDARD_DEVIATION 10.65 • n=4 Participants
Sex: Female, Male Female	37 Participants n=5 Participants	35 Participants n=7 Participants	35 Participants n=5 Participants	107 Participants n=4 Participants
Sex: Female, Male Male	15 Participants n=5 Participants	14 Participants n=7 Participants	15 Participants n=5 Participants	44 Participants n=4 Participants
Region of Enrollment United States	52 participants n=5 Participants	49 participants n=7 Participants	50 participants n=5 Participants	151 participants n=4 Participants

PRIMARY outcome

Timeframe: Immediately after treatment.

Population: Intention to treat (ITT).

Assessment of sensitivity via tactile stimulation immediately after treatment. Tactile sensitivity measured using a Yeaple probe recording tactile pressure in grams before nerve stimulation. Point of nerve stimulation identified by patient with a "yes" response as pressure is increased in 10 gram increments. Tactile sensitivity is reported as the change from baseline after treatment.

Outcome measures

Outcome measures
Measure	NUPRO Sensodyne Prophy Paste w/ Novamin n=52 Participants NUPRO Sensodyne Prophy Paste with Novamin without fluoride. : Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth.	NUPRO Sensodyne Prophy Paste w/ Novamin(r) w/ Fluoride. n=49 Participants NUPRO Sensodyne Prophy Paste with Novamin with fluoride. : Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth.	NUPRO(r) Classic Prophy Paste n=50 Participants NUPRO Classic Prophy Paste : Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth.
Immediate Sensitivity Relief. Tactile Sensitivity.	12.36 grams Standard Deviation 12.91	10.46 grams Standard Deviation 12.58	0.60 grams Standard Deviation 3.45

PRIMARY outcome

Timeframe: Immediately after treatment to 28 days (+/- 2 days) post treatment.

Population: Intent to treat (ITT).

Assessment of adverse events that may occur as a result of treatment (typically includes any kind of allergic reation to paste).

Outcome measures

Outcome measures
Measure	NUPRO Sensodyne Prophy Paste w/ Novamin n=52 Participants NUPRO Sensodyne Prophy Paste with Novamin without fluoride. : Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth.	NUPRO Sensodyne Prophy Paste w/ Novamin(r) w/ Fluoride. n=49 Participants NUPRO Sensodyne Prophy Paste with Novamin with fluoride. : Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth.	NUPRO(r) Classic Prophy Paste n=50 Participants NUPRO Classic Prophy Paste : Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth.
Adverse Events.	0 Number of adverse events.	0 Number of adverse events.	0 Number of adverse events.

PRIMARY outcome

Timeframe: Immediately after treatment.

Sensitivity measurements performed using a cold air blast and sensitivity scored on the four (4) point Schiff scale with 0 equal to no discomfort or awareness of sensitivity and 3 equal to severe pain from sensitive teeth. Score is reported as the change from baseline after treatment.

Outcome measures

Outcome measures
Measure	NUPRO Sensodyne Prophy Paste w/ Novamin n=52 Participants NUPRO Sensodyne Prophy Paste with Novamin without fluoride. : Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth.	NUPRO Sensodyne Prophy Paste w/ Novamin(r) w/ Fluoride. n=49 Participants NUPRO Sensodyne Prophy Paste with Novamin with fluoride. : Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth.	NUPRO(r) Classic Prophy Paste n=50 Participants NUPRO Classic Prophy Paste : Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth.
Immediate Sensitivity Relief. Air Blast Sensitivity.	-0.87 units on a scale Standard Deviation 0.71	-0.86 units on a scale Standard Deviation 0.62	0.00 units on a scale Standard Deviation 0.35

SECONDARY outcome

Timeframe: 28 days (+/- 2 days) post treatment.

Population: Intent to treat (ITT).

Assessment of sensitivity score via tactile stimulation 28 days post treatment. Tactile sensitivity measured using a Yeaple probe recording tactile pressure in grams before nerve stimulation. Point of nerve stimulation identified by patient with "yes" response as pressure is increased in 10 gram increments. Measured sensitivity is reported as difference from baseline examination.

Outcome measures

Outcome measures
Measure	NUPRO Sensodyne Prophy Paste w/ Novamin n=52 Participants NUPRO Sensodyne Prophy Paste with Novamin without fluoride. : Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth.	NUPRO Sensodyne Prophy Paste w/ Novamin(r) w/ Fluoride. n=49 Participants NUPRO Sensodyne Prophy Paste with Novamin with fluoride. : Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth.	NUPRO(r) Classic Prophy Paste n=48 Participants NUPRO Classic Prophy Paste : Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth.
Extended Sensitivity Relief. Tactile Sensitivity.	10.19 grams Standard Deviation 11.37	11.07 grams Standard Deviation 11.90	1.15 grams Standard Deviation 5.88

SECONDARY outcome

Timeframe: 28 days (+/- 2 days) post treatment.

Assessment of cold air sensitivity. Cold air sensitivity measurements performed using a cold air blast and sensitivity scored on the four (4) point Schiff scale with 0 equal to no discomfort or awareness of sensitivity and 3 equal to severe pain from sensitive teeth.

Outcome measures

Outcome measures
Measure	NUPRO Sensodyne Prophy Paste w/ Novamin n=52 Participants NUPRO Sensodyne Prophy Paste with Novamin without fluoride. : Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth.	NUPRO Sensodyne Prophy Paste w/ Novamin(r) w/ Fluoride. n=49 Participants NUPRO Sensodyne Prophy Paste with Novamin with fluoride. : Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth.	NUPRO(r) Classic Prophy Paste n=48 Participants NUPRO Classic Prophy Paste : Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth.
Extended Sensitivity Relief. Air Blast Sensitivity.	-0.94 units on a scale Standard Deviation 0.68	-0.95 units on a scale Standard Deviation 0.66	0.03 units on a scale Standard Deviation 0.47

Adverse Events

NUPRO Sensodyne Prophy Paste w/ Novamin

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

NUPRO Sensodyne Prophy Paste w/ Novamin(r) w/ Fluoride.

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

NUPRO(r) Classic Prophy Paste

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

Jeffery L. Milleman, DDS, MPA

Salus Research, Inc.

Phone: (260) 755-1099

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60