Trial Outcomes & Findings for NUPRO Sensodyne Prophylaxis Paste With NovaMin Sensitivity Relief Study (NCT NCT01669785)

NCT ID: NCT01669785

Last Updated: 2014-08-21

Results Overview

Pre-prophy procedure baseline assessment is measured with an electronic force sensing probe (Yeaple probe). Grams of force needed to elicit pain are recorded as hypersensitivity score for the tooth. 10,20,30,40, up to 50 grams of force are applied to the hypersensitive tooth until pain is elicited. The higher the score (the more grams of force needed to elicit a response of pain), the lower the hypersensitiv Subjects were required to have two sensitive teeth which are not adjacent to each other and preferably in different quadrants. Scores were obtained by taking the average over the scores for the evaluated teeth.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 139 participants
• Primary outcome timeframe: Pre-treatment measurement
• Results posted on: 2014-08-21

Participant Flow

Participant milestones

Measure	Group A NUPRO Sensodyne Prophy Paste w/ Novamin Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains 15% Novamin. Does not contain Fluoride. Leave in contact for 60 seconds, rinse with water and expectorate.	Group B NUPRO Sensodyne Prophy Paste w/ Novamin w/ Fluoride Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains 1.23% fluoride ion and 15% Novamin. Leave in contact for 60 seconds, rinse with water and expectorate.	Group C NUPRO Classic Prophy Paste Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains no Novamin or Fluoride.. Leave in contact for 60 seconds, rinse with water and expectorate.
Overall Study STARTED	45	48	46
Overall Study COMPLETED	45	48	46
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

NUPRO Sensodyne Prophylaxis Paste With NovaMin Sensitivity Relief Study

Baseline characteristics by cohort

Measure	Group A n=45 Participants NUPRO Sensodyne Prophy Paste w/ Novamin. Administered on day one only.Unit dose cup contained enough paste for a single procedure. Contains 15% Novamin. Does not contain Fluoride. Leave in contact for 60 seconds, rinse with water and expectorate.	Group B n=48 Participants NUPRO Sensodyne Prophy Paste w/ Novamin w/ Fluoride.Administered on day one only.Unit dose cup contained enough paste for a single procedure. Contains 1.23% fluoride ion and 15% Novamin. Leave in contact for 60 seconds, rinse with water and expectorate.	Group C n=46 Participants NUPRO Classic Prophy Paste.Administered on day one only.Unit dose cup contained enough paste for a single procedure. Contains no Novamin or Fluoride.Leave in contact for 60 seconds, rinse with water and expectorate.	Total n=139 Participants Total of all reporting groups
Age, Customized	44 mean years of age STANDARD_DEVIATION 11.18274 • n=5 Participants	41 mean years of age STANDARD_DEVIATION 11.21829 • n=7 Participants	43 mean years of age STANDARD_DEVIATION 10.928 • n=5 Participants	43 mean years of age STANDARD_DEVIATION 11.10967 • n=4 Participants
Sex: Female, Male Female	36 Participants n=5 Participants	39 Participants n=7 Participants	35 Participants n=5 Participants	110 Participants n=4 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	9 Participants n=7 Participants	11 Participants n=5 Participants	29 Participants n=4 Participants
Region of Enrollment United States	45 participants n=5 Participants	48 participants n=7 Participants	46 participants n=5 Participants	139 participants n=4 Participants

PRIMARY outcome

Timeframe: Pre-treatment measurement

Pre-prophy procedure baseline assessment is measured with an electronic force sensing probe (Yeaple probe). Grams of force needed to elicit pain are recorded as hypersensitivity score for the tooth. 10,20,30,40, up to 50 grams of force are applied to the hypersensitive tooth until pain is elicited. The higher the score (the more grams of force needed to elicit a response of pain), the lower the hypersensitiv

Subjects were required to have two sensitive teeth which are not adjacent to each other and preferably in different quadrants. Scores were obtained by taking the average over the scores for the evaluated teeth.

Outcome measures

Measure	Group A n=45 Participants NUPRO Sensodyne Prophy Paste w/ Novamin Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains 15% Novamin. Does not contain Fluoride. Leave in contact for 60 seconds, rinse with water and expectorate.	Group B n=48 Participants NUPRO Sensodyne Prophy Paste w/ Novamin w/ Fluoride Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains 1.23% fluoride ion and 15% Novamin. Leave in contact for 60 seconds, rinse with water and expectorate.	Group C n=46 Participants NUPRO Classic Prophy Paste Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains no Novamin or Fluoride.. Leave in contact for 60 seconds, rinse with water and expectorate.
Baseline Pre-Prophy Assessment (Tactile Sensitivity)	10.56 grams Standard Deviation 1.59	10.00 grams Standard Deviation 0.00	10.98 grams Standard Deviation 2.27

PRIMARY outcome

Timeframe: Immediately after treatment .

Assessment of sensitivity score via tactile and air blast measurements immediately after treatment. Tactile hypersensitivity is measured with an electronic force sensing probel (Yeaple probe). Grams of force needed to elicit pain are recorded as hypersensitivity score for the tooth. Grams of force needed to elicit pain are recorded as hypersensitivity score for the tooth. 10, 20, 30, 40 up to 50 grams of force are applied to the hypersensitive tooth until pain is elicited. The higher the score (the more grams of force needed to elicit a response of pain), the lower the hypersensitivity.

Subjects were required to have two sensitive teeth which are not adjacent to each other and preferably in different quadrants. Scores were obtained by taking the average over the scores for the evaluated teeth.

Outcome measures

Measure	Group A n=45 Participants NUPRO Sensodyne Prophy Paste w/ Novamin Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains 15% Novamin. Does not contain Fluoride. Leave in contact for 60 seconds, rinse with water and expectorate.	Group B n=48 Participants NUPRO Sensodyne Prophy Paste w/ Novamin w/ Fluoride Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains 1.23% fluoride ion and 15% Novamin. Leave in contact for 60 seconds, rinse with water and expectorate.	Group C n=46 Participants NUPRO Classic Prophy Paste Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains no Novamin or Fluoride.. Leave in contact for 60 seconds, rinse with water and expectorate.
Immediate Sensitivity Relief (Tactile Sensitivity)	19.61 grams Standard Deviation 11.31	16.67 grams Standard Deviation 9.01	12.01 grams Standard Deviation 5.52

PRIMARY outcome

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

Assessment of sensitivity score via tactile measurements long term after treatment.

Tactile hypersensitivity is measured with an electronic force sensing probel (Yeaple probe). Grams of force needed to elicit pain are recorded as hypersensitivity score for the tooth. Grams of force needed to elicit pain are recorded as hypersensitivity score for the tooth. 10 to 50 grams of force are applied to the hypersensitive tooth until pain is elicited. The higher the score (the more grams of force needed to elicit a response of pain), the lower the hypersensitivity.

Subjects were required to have two sensitive teeth which are not adjacent to each other and preferably in different quadrants. Scores were obtained by taking the average over the scores for the evaluated teeth.

Outcome measures

Measure	Group A n=45 Participants NUPRO Sensodyne Prophy Paste w/ Novamin Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains 15% Novamin. Does not contain Fluoride. Leave in contact for 60 seconds, rinse with water and expectorate.	Group B n=48 Participants NUPRO Sensodyne Prophy Paste w/ Novamin w/ Fluoride Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains 1.23% fluoride ion and 15% Novamin. Leave in contact for 60 seconds, rinse with water and expectorate.	Group C n=46 Participants NUPRO Classic Prophy Paste Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains no Novamin or Fluoride.. Leave in contact for 60 seconds, rinse with water and expectorate.
Long-term Sensitivity Relief (Tactile Sensitivity)	19.89 grams Standard Deviation 11.46	16.51 grams Standard Deviation 10.35	12.07 grams Standard Deviation 5.20

PRIMARY outcome

Timeframe: Pre-treatment measurement

Pre-prophy procedure baseline assessment using Schiff Cold Air Sensitivity scale (0-3).

Air blast hypersensitivity is measured using the Schiff Cold Air Sensitivty scale (0-3). The scale is scored as follows:

0=Subject does not respond to stimulus; 1= Subject responds to stimulus but does not request discontinuation of stimulus; 2=Subject responds to stimulus and requests discontinuation or moves from air stimulus; 3=Subject responds to stimulus, considers it painful and requests discontinuation.

The higher the score, the higher the hypersensitivity.

Subjects were required to have two sensitive teeth which are not adjacent to each other and preferably in different quadrants. Scores were obtained by taking the average over the scores for the evaluated teeth.

Outcome measures

Measure	Group A n=45 Participants NUPRO Sensodyne Prophy Paste w/ Novamin Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains 15% Novamin. Does not contain Fluoride. Leave in contact for 60 seconds, rinse with water and expectorate.	Group B n=48 Participants NUPRO Sensodyne Prophy Paste w/ Novamin w/ Fluoride Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains 1.23% fluoride ion and 15% Novamin. Leave in contact for 60 seconds, rinse with water and expectorate.	Group C n=46 Participants NUPRO Classic Prophy Paste Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains no Novamin or Fluoride.. Leave in contact for 60 seconds, rinse with water and expectorate.
Baseline Pre-Prophy Assessment (Air Blast Sensitivity)	1.72 units on a scale Standard Deviation 0.58	1.70 units on a scale Standard Deviation 0.58	1.65 units on a scale Standard Deviation 0.60

PRIMARY outcome

Timeframe: Immediately after treatment .

Assessment of sensitivity score via air blast measurements immediately after treatment.

Air blast hypersensitivity is measured using the Schiff Cold Air Sensitivity scale (0-3). The scale is scored as follows:

0=Subject does not respond to stimulus; 1= Subject responds to stimulus but does not request discontinuation of stimulus; 2=Subject responds to stimulus and requests discontinuation or moves from air stimulus; 3=Subject responds to stimulus, considers it painful and requests discontinuation.

Subjects were required to have two sensitive teeth which are not adjacent to each other and preferably in different quadrants. Scores were obtained by taking the average over the scores for the evaluated teeth.

Outcome measures

Measure	Group A n=45 Participants NUPRO Sensodyne Prophy Paste w/ Novamin Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains 15% Novamin. Does not contain Fluoride. Leave in contact for 60 seconds, rinse with water and expectorate.	Group B n=48 Participants NUPRO Sensodyne Prophy Paste w/ Novamin w/ Fluoride Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains 1.23% fluoride ion and 15% Novamin. Leave in contact for 60 seconds, rinse with water and expectorate.	Group C n=46 Participants NUPRO Classic Prophy Paste Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains no Novamin or Fluoride.. Leave in contact for 60 seconds, rinse with water and expectorate.
Immediate Sensitivity Relief (Schiff Air Blast Sensitivity)	0.88 units on a scale Standard Deviation 0.64	0.97 units on a scale Standard Deviation 0.52	1.72 units on a scale Standard Deviation 0.70

PRIMARY outcome

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

Assessment of sensitivity score Schiff air blast measurements long term after treatment.

Air blast hypersensitivity is measured using the Schiff Cold Air Sensitivity scale (0-3). The scale is scored as follows:

0=Subject does not respond to stimulus; 1= Subject responds to stimulus but does not request discontinuation of stimulus; 2=Subject responds to stimulus and requests discontinuation or moves from air stimulus; 3=Subject responds to stimulus, considers it painful and requests discontinuation.

Subjects were required to have two sensitive teeth which are not adjacent to each other and preferably in different quadrants. Scores were obtained by taking the average over the scores for the evaluated teeth.

Outcome measures

Measure	Group A n=45 Participants NUPRO Sensodyne Prophy Paste w/ Novamin Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains 15% Novamin. Does not contain Fluoride. Leave in contact for 60 seconds, rinse with water and expectorate.	Group B n=48 Participants NUPRO Sensodyne Prophy Paste w/ Novamin w/ Fluoride Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains 1.23% fluoride ion and 15% Novamin. Leave in contact for 60 seconds, rinse with water and expectorate.	Group C n=46 Participants NUPRO Classic Prophy Paste Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains no Novamin or Fluoride.. Leave in contact for 60 seconds, rinse with water and expectorate.
Long-term Sensitivity Relief (Schiff Air Blast Sensitivity)	0.87 units on a scale Standard Deviation 0.63	1.11 units on a scale Standard Deviation 0.61	1.67 units on a scale Standard Deviation 0.67

SECONDARY outcome

Timeframe: Pre-Treatment

All subjects completed a questionnaire titled "How sensitive are your teeth?" to assess their whole-mouth tooth sensitivity prior to the baseline assessments.

The questionnaire contained a 4-item verbal descriptor scale as follows:

Score 0= no discomfort or awareness of sensitivity; 1=mild discomfort/pain from sensitive teeth; 2=moderate discomfort/pain from sensitive teeth; 3=severe pain from sensitive teeth.

The higher the score, the higher the hypersensitivity.

Subjects were required to have two sensitive teeth which are not adjacent to each other and preferably in different quadrants. Scores were obtained by taking the average over the scores for the evaluated teeth.

Outcome measures

Measure	Group A n=45 Participants NUPRO Sensodyne Prophy Paste w/ Novamin Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains 15% Novamin. Does not contain Fluoride. Leave in contact for 60 seconds, rinse with water and expectorate.	Group B n=48 Participants NUPRO Sensodyne Prophy Paste w/ Novamin w/ Fluoride Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains 1.23% fluoride ion and 15% Novamin. Leave in contact for 60 seconds, rinse with water and expectorate.	Group C n=46 Participants NUPRO Classic Prophy Paste Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains no Novamin or Fluoride.. Leave in contact for 60 seconds, rinse with water and expectorate.
Sensitivity Relief (Self-Assessment)	0.82 units on a scale Standard Deviation 0.72	0.67 units on a scale Standard Deviation 0.75	0.76 units on a scale Standard Deviation 0.74

SECONDARY outcome

Timeframe: Post-scaling procedure,immediate

All subjects completed a questionnaire titled "How sensitive are your teeth?" to assess their whole-mouth tooth sensitivity immediately following the scaling procedure.

The questionnaire contained a 4-item verbal descriptor scale as follows:

Score 0= no discomfort or awareness of sensitivity; 1=mild discomfort/pain from sensitive teeth; 2=moderate discomfort/pain from sensitive teeth; 3=severe pain from sensitive teeth.

The higher the score, the higher the hypersensitivity.

Subjects were required to have two sensitive teeth which are not adjacent to each other and preferably in different quadrants. Scores were obtained by taking the average over the scores for the evaluated teeth.

Outcome measures

Measure	Group A n=45 Participants NUPRO Sensodyne Prophy Paste w/ Novamin Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains 15% Novamin. Does not contain Fluoride. Leave in contact for 60 seconds, rinse with water and expectorate.	Group B n=48 Participants NUPRO Sensodyne Prophy Paste w/ Novamin w/ Fluoride Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains 1.23% fluoride ion and 15% Novamin. Leave in contact for 60 seconds, rinse with water and expectorate.	Group C n=46 Participants NUPRO Classic Prophy Paste Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains no Novamin or Fluoride.. Leave in contact for 60 seconds, rinse with water and expectorate.
Post- Scaling Sensitivity Relief (Self-Assessment)	1.31 units on a scale Standard Deviation 0.79	0.98 units on a scale Standard Deviation 0.67	1.28 units on a scale Standard Deviation 0.72

SECONDARY outcome

Timeframe: Immediately following post-prophylaxis treatment.

All subjects completed a questionnaire titled "How sensitive are your teeth?" to assess their whole-mouth tooth sensitivity immediately following the timed, 1-minute prophylaxis paste application.

The questionnaire contained a 4-item verbal descriptor scale as follows:

Score 0= no discomfort or awareness of sensitivity; 1=mild discomfort/pain from sensitive teeth;2=moderate discomfort/pain from sensitive teeth; 3=severe pain from sensitive teeth.

The higher the score, the higher the hypersensitivity.

Subjects were required to have two sensitive teeth which are not adjacent to each other and preferably in different quadrants. Scores were obtained by taking the average over the scores for the evaluated teeth.

Outcome measures

Measure	Group A n=45 Participants NUPRO Sensodyne Prophy Paste w/ Novamin Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains 15% Novamin. Does not contain Fluoride. Leave in contact for 60 seconds, rinse with water and expectorate.	Group B n=48 Participants NUPRO Sensodyne Prophy Paste w/ Novamin w/ Fluoride Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains 1.23% fluoride ion and 15% Novamin. Leave in contact for 60 seconds, rinse with water and expectorate.	Group C n=46 Participants NUPRO Classic Prophy Paste Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains no Novamin or Fluoride.. Leave in contact for 60 seconds, rinse with water and expectorate.
Post-prophylaxis Sensitivity Relief (Self-Assessment)	1.00 units on a scale Standard Deviation 0.90	0.90 units on a scale Standard Deviation 0.81	1.09 units on a scale Standard Deviation 0.69

SECONDARY outcome

Timeframe: 28 days post-prophylaxis treatment.

All subjects completed a questionnaire titled "How sensitive are your teeth?" to assess their whole-mouth tooth sensitivity 28 days following prophylaxis treatment.

The questionnaire contained a 4-item verbal descriptor scale as follows:

Score 0= no discomfort or awareness of sensitivity;1=mild discomfort/pain from sensitive teeth; 2=moderate discomfort/pain from sensitive teeth; 3=severe pain from sensitive teeth.

The higher the score, the higher the hypersensitivity.

Subjects were required to have two sensitive teeth which are not adjacent to each other and preferably in different quadrants. Scores were obtained by taking the average over the scores for the evaluated teeth.

Outcome measures

Measure	Group A n=45 Participants NUPRO Sensodyne Prophy Paste w/ Novamin Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains 15% Novamin. Does not contain Fluoride. Leave in contact for 60 seconds, rinse with water and expectorate.	Group B n=48 Participants NUPRO Sensodyne Prophy Paste w/ Novamin w/ Fluoride Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains 1.23% fluoride ion and 15% Novamin. Leave in contact for 60 seconds, rinse with water and expectorate.	Group C n=46 Participants NUPRO Classic Prophy Paste Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains no Novamin or Fluoride.. Leave in contact for 60 seconds, rinse with water and expectorate.
Long-term Sensitivity Relief (Self-Assessment)	0.60 units on a scale Standard Deviation 0.62	0.50 units on a scale Standard Deviation 0.71	0.72 units on a scale Standard Deviation 0.69

Adverse Events

Group A

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Group B

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Group C

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