Tooth Hypersensitivity
Conditions
Brief summary
The study is intended to verify through clinical measurement that the NUPRO Sensodyne Prophylaxis Paste with Novamin provides immediate sensitivity relief as well as extended relief up to 28 days.
Detailed description
It is hypothesized that the prophy paste with Novamin will give patients immediate sensitivity relief, as well as sensitivity relief up to 4 weeks (28 days) after measurement.
Interventions
DEVICEGroup C
Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth.
DEVICEGroup A
Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth.
DEVICEGroup B
Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth.
Sponsors
Dentsply International
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* Availability to complete in the 28 day duration. * Two sensitive teeth, which are not adjacent to each other and preferably in different quadrants, which demonstrate cervical erosion, abrasion and gingival recession. * Qualifying response to tactile stimuli as defined by a score of \</= 20 grams. * Qualifying response to air blast stimuli as defined by a score of \>/= 1 on the Schiff Cold Air Sensitivity Scale. * Subjects need to satisfy the qualifying response to stimuli for both parameters assesses (Tactile or Air Blast) on at least two teeth (non-adjacent) to be entered into the study. * Good general health with no known allergies to products being tested. * Use of a non-desensitizing dentifrice for 2 weeks prior to entry into the study. * Subjects must have a minimum of 10 natural teeth, excluding 3rd molars.
Exclusion criteria
* Individuals who exhibit gross oral pathology. * Females who may be pregnant or lactating or intending to become pregnant. * Individuals who require anesthetic during scaling. * Dental pathology which may cause pain similar to tooth sensitivity. * Individuals with large amounts of calculus. * Subjects with active infectious diseases such as hepatitis, HIV, or tuberculosis. * Any condition requiring antibiotic prophylaxis for dental treatment. * Excessive gingival inflammation. * Individuals who had their teeth cleaned within 30 days of the screening appointment. * Individuals who have had desensitizing treatment or tooth bleaching within 90 days of screening appointment. * Oral pathology, chronic disease, or history of allergy to test products. * Advanced periodontal disease or treatment for periodontal disease (including surgery) within the past twelve months. * Sensitive teeth with mobility greater than one. * Teeth with extensive/defective restorations (including prosthetic crowns), suspected pulpitis, caries, cracked enamel, or used as abutments for removable partial dentures. * Regular use of sedatives, anti-inflammatory drugs, or analgesic. * Participation in a desensitizing dentifrice study or regular use of a desensitizing dentifrice within the past 4 weeks. * Current participation in any other clinical study or receipt of an investigational drug within 30 days of the screening visit at the start of the study. * Personnel; a) an employee of the sponsor; b0 A member or relative of teh study site staff directly involved with the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Baseline Pre-Prophy Assessment (Tactile Sensitivity) | 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. |
| Long-term Sensitivity Relief (Tactile Sensitivity) | 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. |
| Baseline Pre-Prophy Assessment (Air Blast Sensitivity) | 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. |
| Immediate Sensitivity Relief (Schiff Air Blast Sensitivity) | 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. |
| Long-term Sensitivity Relief (Schiff Air Blast Sensitivity) | 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. |
| Immediate Sensitivity Relief (Tactile Sensitivity) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Post- Scaling Sensitivity Relief (Self-Assessment) | 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. |
| Post-prophylaxis Sensitivity Relief (Self-Assessment) | 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. |
| Long-term Sensitivity Relief (Self-Assessment) | 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. |
| Sensitivity Relief (Self-Assessment) | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 45 |
| 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. | 48 |
| 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. | 46 |
| Total | 139 |
Baseline characteristics
| Characteristic | Group A | Group B | Group C | Total |
|---|---|---|---|---|
| Age, Customized | 44 mean years of age STANDARD_DEVIATION 11.18274 | 41 mean years of age STANDARD_DEVIATION 11.21829 | 43 mean years of age STANDARD_DEVIATION 10.928 | 43 mean years of age STANDARD_DEVIATION 11.10967 |
| Region of Enrollment United States | 45 participants | 48 participants | 46 participants | 139 participants |
| Sex: Female, Male Female | 36 Participants | 39 Participants | 35 Participants | 110 Participants |
| Sex: Female, Male Male | 9 Participants | 9 Participants | 11 Participants | 29 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 45 | 0 / 48 | 0 / 46 |
| serious Total, serious adverse events | 0 / 45 | 0 / 48 | 0 / 46 |
Outcome results
Primary
Baseline Pre-Prophy Assessment (Air Blast Sensitivity)
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.
Time frame: Pre-treatment measurement
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group A | Baseline Pre-Prophy Assessment (Air Blast Sensitivity) | 1.72 units on a scale | Standard Deviation 0.58 |
| Group B | Baseline Pre-Prophy Assessment (Air Blast Sensitivity) | 1.70 units on a scale | Standard Deviation 0.58 |
| Group C | Baseline Pre-Prophy Assessment (Air Blast Sensitivity) | 1.65 units on a scale | Standard Deviation 0.6 |
Primary
Baseline Pre-Prophy Assessment (Tactile Sensitivity)
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.
Time frame: Pre-treatment measurement
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group A | Baseline Pre-Prophy Assessment (Tactile Sensitivity) | 10.56 grams | Standard Deviation 1.59 |
| Group B | Baseline Pre-Prophy Assessment (Tactile Sensitivity) | 10.00 grams | Standard Deviation 0 |
| Group C | Baseline Pre-Prophy Assessment (Tactile Sensitivity) | 10.98 grams | Standard Deviation 2.27 |
Primary
Immediate Sensitivity Relief (Schiff Air Blast Sensitivity)
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.
Time frame: Immediately after treatment .
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group A | Immediate Sensitivity Relief (Schiff Air Blast Sensitivity) | 0.88 units on a scale | Standard Deviation 0.64 |
| Group B | Immediate Sensitivity Relief (Schiff Air Blast Sensitivity) | 0.97 units on a scale | Standard Deviation 0.52 |
| Group C | Immediate Sensitivity Relief (Schiff Air Blast Sensitivity) | 1.72 units on a scale | Standard Deviation 0.7 |
Primary
Immediate Sensitivity Relief (Tactile Sensitivity)
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.
Time frame: Immediately after treatment .
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group A | Immediate Sensitivity Relief (Tactile Sensitivity) | 19.61 grams | Standard Deviation 11.31 |
| Group B | Immediate Sensitivity Relief (Tactile Sensitivity) | 16.67 grams | Standard Deviation 9.01 |
| Group C | Immediate Sensitivity Relief (Tactile Sensitivity) | 12.01 grams | Standard Deviation 5.52 |
Primary
Long-term Sensitivity Relief (Schiff Air Blast Sensitivity)
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.
Time frame: 28 days (+/- 2 days) post treatment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group A | Long-term Sensitivity Relief (Schiff Air Blast Sensitivity) | 0.87 units on a scale | Standard Deviation 0.63 |
| Group B | Long-term Sensitivity Relief (Schiff Air Blast Sensitivity) | 1.11 units on a scale | Standard Deviation 0.61 |
| Group C | Long-term Sensitivity Relief (Schiff Air Blast Sensitivity) | 1.67 units on a scale | Standard Deviation 0.67 |
Primary
Long-term Sensitivity Relief (Tactile Sensitivity)
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.
Time frame: 28 days (+/- 2 days) post treatment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group A | Long-term Sensitivity Relief (Tactile Sensitivity) | 19.89 grams | Standard Deviation 11.46 |
| Group B | Long-term Sensitivity Relief (Tactile Sensitivity) | 16.51 grams | Standard Deviation 10.35 |
| Group C | Long-term Sensitivity Relief (Tactile Sensitivity) | 12.07 grams | Standard Deviation 5.2 |
Secondary
Long-term Sensitivity Relief (Self-Assessment)
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.
Time frame: 28 days post-prophylaxis treatment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group A | Long-term Sensitivity Relief (Self-Assessment) | 0.60 units on a scale | Standard Deviation 0.62 |
| Group B | Long-term Sensitivity Relief (Self-Assessment) | 0.50 units on a scale | Standard Deviation 0.71 |
| Group C | Long-term Sensitivity Relief (Self-Assessment) | 0.72 units on a scale | Standard Deviation 0.69 |
Secondary
Post-prophylaxis Sensitivity Relief (Self-Assessment)
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.
Time frame: Immediately following post-prophylaxis treatment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group A | Post-prophylaxis Sensitivity Relief (Self-Assessment) | 1.00 units on a scale | Standard Deviation 0.9 |
| Group B | Post-prophylaxis Sensitivity Relief (Self-Assessment) | 0.90 units on a scale | Standard Deviation 0.81 |
| Group C | Post-prophylaxis Sensitivity Relief (Self-Assessment) | 1.09 units on a scale | Standard Deviation 0.69 |
Secondary
Post- Scaling Sensitivity Relief (Self-Assessment)
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.
Time frame: Post-scaling procedure,immediate
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group A | Post- Scaling Sensitivity Relief (Self-Assessment) | 1.31 units on a scale | Standard Deviation 0.79 |
| Group B | Post- Scaling Sensitivity Relief (Self-Assessment) | 0.98 units on a scale | Standard Deviation 0.67 |
| Group C | Post- Scaling Sensitivity Relief (Self-Assessment) | 1.28 units on a scale | Standard Deviation 0.72 |
Secondary
Sensitivity Relief (Self-Assessment)
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.
Time frame: Pre-Treatment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group A | Sensitivity Relief (Self-Assessment) | 0.82 units on a scale | Standard Deviation 0.72 |
| Group B | Sensitivity Relief (Self-Assessment) | 0.67 units on a scale | Standard Deviation 0.75 |
| Group C | Sensitivity Relief (Self-Assessment) | 0.76 units on a scale | Standard Deviation 0.74 |