Dentin Hypersensitivity
Conditions
Keywords
Dentine hypersensitivity, Dentine Sensitivity, Oral dentifrices, Bio-active glasses
Brief summary
This will be multi-centered, triple blinded, randomized, four parallel treatments assigned study to compare clinical efficacy of commercially available dentifrices with placebo for immediate and sustained relief from Dentin Hypersensitivity after short term use. Condition or disease: Dentin hypersensitivity Intervention/Treatment: Product 1; Fluoro-Calcium-Phospho-silicate based BioMin F Product 2; Pro-Argin formula based Colgate Sensitive Pro-Relief Product 3; Strontium Acetate based Sensodyne Rapid Action Product 4; Sodium Fluoride based Colgate Total
Detailed description
It is a randomized controlled clinical trial with non invasive topical intervention in 140 adult patients of 18 to 60 years age, that will be selected randomly after screening and diagnosis of dentin hypersensitivity, in dental Out Patient Department of Periodontology. Written informed consent will be obtained. Participants will be allocated randomly into four equal study arms for parallel treatment assignment with dentifrices named BioMin F, Colgate Sensitive Pro-Relief Trade Mark,Sensodyne rapid action Trade Mark and Colgate Total Trade Mark dentifrices. Colgate total Trade Mark dentifrices does not claim pain relief in Dentin Hypersensitivity. Interim efficacy will be assessed immediately after topical application on sensitive teeth, in one minute, after 5 minutes, on day three and week 4 respectively. Dentin hypersensitivity will be tested with mechanical stimulus, evaporative air blast stimulus and water jet stimulus. It will be measured on Visual Analogue Scale and Schiff cold air sensitivity scale (SCASS). Statistical analysis will be done using ANOVA in Statistical Package for Social Sciences software 21.
Interventions
DRUGFluoro-Calcium-Phospho-Silicate based dentifrices
Bio-Active glass based formulation
DRUG8% Arginine based dentifrices
Tubular occluding formulation
DRUG8% Strontium Acetate
Tubular occluding formulation
DRUGSodium Fluoride
No claim of relieving Dentin Hypersensitivity
Sponsors
Dow University of Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
Statistician will be masked.
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* Subjects with at least two teeth sensitive to cold, touch and air blow stimulus * Sensitive teeth anterior to molars either due to erosions or abrasions with or without associated gingival recession * Teeth with Linear Visual Analogue Scale (VAS) score of ≥ 4 and code 2 of Schiff Cold Air Sensitivity Scale on screening.
Exclusion criteria
* Subjects with worst pain response at 100mm on VAS.(Visual Analog Scale) * Teeth with orthodontic or prosthetic appliances, Caries, restorations or cracks * Localized or generalized gingivitis or pulpitis with heavy calculus * Periodontal surgery in the preceding three months * Patients using any desensitizing tooth paste or mouth wash up to six weeks before study and taking drugs like anti-inflammatory, sedatives, tranquilizers, analgesics in routine. * Pregnant or breastfeeding females.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change in Mean Score of Pain Response From Baseline on Schiff Cold Air Sensitivity Scale Using Air Blast Stimulus | (Base line to 1 minute) (Base line to 5 minutes)(Base line to day 3)(Base line to week 4) | SCHIFF cold air sensitivity scale was used to measure the intensity of pain due to dentin hypersensitivity using air blast stimulus. Patients' response of pain was assessed by the doctor according to following score range from; 0(no response of pain), 1 (pain response but no request of discontinuity of stimulus), 2(pain response with request of discontinuity of stimulus), 3(Immediate pain response for discontinuity of stimulus). Percent change in mean scores = ( one minute score-Baseline score) / Baseline score |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change in Mean Scores of Pain Response From Baseline on Visual Analog Scale Using Mechanical Stimulus | (Base line to 1 minute) (Base line to 5 minutes)(Base line to day 3)(Base line to week 4) | Visual Analogue Scale was used to measure the intensity of pain due to dentin hypersensitivity using mechanical stimulus. Patient's response of pain was assessed on vertical line of 0 to 10cm by asking him to move finger on the line and stop it where he felt pain. Score range from; 0 (no pain at 0cm), 1(mild pain at 1cm), 2(mild pain at 2cm), 3(mild pain at 3cm), 4(moderate pain at 4cm), 5(moderate pain at 5cm), 6(moderate pain at 6cm), 7(severe pain at 7cm), 8(severe pain at 8cm), 9(severe pain at 9cm),10(worst imaginable pain at 10cm). Percent change in mean scores = (one minute score-Baseline score) / Baseline score |
| Percent Change in Mean Scores of Pain Response From Baseline on Visual Analog Scale Using Water Jet Stimulus | (Base line to 1 minute) (Base line to 5 minutes)(Base line to day 3)(Base line to week 4) | Visual Analogue Scale was used to measure the intensity of pain due to dentin hypersensitivity using Water Jet Stimulus. Patient's response of pain was assessed on vertical line of 0 to 10cm by asking him to move finger on the line and stop it where he felt pain. Score range from; 0 (no pain at 0cm), 1(mild pain at 1cm), 2(mild pain at 2cm), 3(mild pain at 3cm), 4(moderate pain at 4cm), 5(moderate pain at 5cm), 6(moderate pain at 6cm), 7(severe pain at 7cm), 8(severe pain at 8cm), 9(severe pain at 9cm),10(worst imaginable pain at 10cm). Percent change in mean scores = (one minute score-Baseline score) / Baseline score |
Countries
Pakistan
Participant flow
Recruitment details
Participants were recruited and enrolled based on self reported sensitivity in teeth followed by clinical diagnosis of dentin hypersensitivity using Air blast stimulus response on SCHIFF Air Blast Sensitivity Scale at Department of Periodontology, Dr. Ishrat-ul-Ibad Khan Institute of Oral Health Sciences, DUHS, Karachi between September 2019 to December 2020. The first Participant was enrolled in September 27, 2019 and last participant was enrolled in October 2020.
Pre-assignment details
Of 380 assessed participants of self reported sensitivity in teeth, 140 met inclusion criteria and were randomized to treatment.
Participants by arm
| Arm | Count |
|---|---|
| BioMin F Dentifrices Participants were instructed to dose a dry toothbrush with a full strip of dentifrices and to brush teeth for 1 minute twice daily.
Fluoro-Calcium-Phospho-Silicate based dentifrices: Bio-Active glass based formulation | 32 |
| Colgate Sensitive Pro Relief Trademark Dentifrices Participants were instructed to dose a dry toothbrush with a full strip of dentifrices and to brush teeth for 1 minute twice daily.
8% Arginine based dentifrices: Tubular occluding formulation | 32 |
| Sensodyne Rapid Action Trademark Dentifrices Participants were instructed to dose a dry toothbrush with a full strip of dentifrices and to brush teeth for 1 minute twice daily.
8% Strontium Acetate: Tubular occluding formulation | 32 |
| Colgate Total Trademark Participants were instructed to dose a dry toothbrush with a full strip of dentifrices and to brush teeth for 1 minute twice daily.
Sodium Fluoride: No claim of relieving Dentin Hypersensitivity | 32 |
| Total | 128 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 3 | 3 | 3 | 3 |
Baseline characteristics
| Characteristic | BioMin F Dentifrices | Colgate Sensitive Pro Relief Trademark Dentifrices | Sensodyne Rapid Action Trademark Dentifrices | Colgate Total Trademark | Total |
|---|---|---|---|---|---|
| Age, Continuous | 33.23 years STANDARD_DEVIATION 8.77 | 34.40 years STANDARD_DEVIATION 8.43 | 35.63 years STANDARD_DEVIATION 9.55 | 34.14 years STANDARD_DEVIATION 9.08 | 34.10 years STANDARD_DEVIATION 8.93 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 32 Participants | 32 Participants | 32 Participants | 32 Participants | 128 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 22 Participants | 21 Participants | 17 Participants | 20 Participants | 80 Participants |
| Sex: Female, Male Male | 10 Participants | 11 Participants | 15 Participants | 12 Participants | 48 Participants |
| Summary of the baseline SCHIFF cold air sensitivity scale for air blast stimulus response | 2.46 scores on a scale STANDARD_DEVIATION 0.5 | 2.46 scores on a scale STANDARD_DEVIATION 0.5 | 2.46 scores on a scale STANDARD_DEVIATION 0.5 | 2.46 scores on a scale STANDARD_DEVIATION 0.5 | 2.46 scores on a scale STANDARD_DEVIATION 0.5 |
| Summary of the baseline Visual Analog scale for Mechanical and Water jet stimulus response Mechanical hypersensitivity baseline score | 6.75 scores on a scale STANDARD_DEVIATION 0.91 | 6.70 scores on a scale STANDARD_DEVIATION 1.03 | 6.70 scores on a scale STANDARD_DEVIATION 1.17 | 6.70 scores on a scale STANDARD_DEVIATION 1.03 | 6.71 scores on a scale STANDARD_DEVIATION 1.02 |
| Summary of the baseline Visual Analog scale for Mechanical and Water jet stimulus response Water Jet hypersensitivity baseline score | 6.70 scores on a scale STANDARD_DEVIATION 0.8 | 6.18 scores on a scale STANDARD_DEVIATION 2.23 | 6.75 scores on a scale STANDARD_DEVIATION 0.91 | 6.48 scores on a scale STANDARD_DEVIATION 1.69 | 6.52 scores on a scale STANDARD_DEVIATION 1.54 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 35 | 0 / 35 | 0 / 35 | 0 / 35 |
| other Total, other adverse events | 0 / 35 | 0 / 35 | 0 / 35 | 0 / 35 |
| serious Total, serious adverse events | 0 / 35 | 0 / 35 | 0 / 35 | 0 / 35 |
Outcome results
Primary
Percent Change in Mean Score of Pain Response From Baseline on Schiff Cold Air Sensitivity Scale Using Air Blast Stimulus
SCHIFF cold air sensitivity scale was used to measure the intensity of pain due to dentin hypersensitivity using air blast stimulus. Patients' response of pain was assessed by the doctor according to following score range from; 0(no response of pain), 1 (pain response but no request of discontinuity of stimulus), 2(pain response with request of discontinuity of stimulus), 3(Immediate pain response for discontinuity of stimulus). Percent change in mean scores = ( one minute score-Baseline score) / Baseline score
Time frame: (Base line to 1 minute) (Base line to 5 minutes)(Base line to day 3)(Base line to week 4)
Population: 35 individuals per treatment group were recruited and enrolled in the study after clinical diagnosis of dentin hypersensitivity using air blast stimulus and SCHIFF cold air sensitivity scale. These participants were tested again for dentin hypersensitivity using mechanical stimulus and Visual Analogue Scale. After lost to follow up, statistical analysis was performed for 32 participants per group with baseline SCHIFF scale score of ≥2.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BioMin F | Percent Change in Mean Score of Pain Response From Baseline on Schiff Cold Air Sensitivity Scale Using Air Blast Stimulus | 1- minute | 18 percentage of change in mean scores | Standard Deviation 21 |
| BioMin F | Percent Change in Mean Score of Pain Response From Baseline on Schiff Cold Air Sensitivity Scale Using Air Blast Stimulus | 5-minutes | 27 percentage of change in mean scores | Standard Deviation 22 |
| BioMin F | Percent Change in Mean Score of Pain Response From Baseline on Schiff Cold Air Sensitivity Scale Using Air Blast Stimulus | Day-3 | 22 percentage of change in mean scores | Standard Deviation 22 |
| BioMin F | Percent Change in Mean Score of Pain Response From Baseline on Schiff Cold Air Sensitivity Scale Using Air Blast Stimulus | Week-4 | 58 percentage of change in mean scores | Standard Deviation 26 |
| Colgate Sensitive Pro Relief | Percent Change in Mean Score of Pain Response From Baseline on Schiff Cold Air Sensitivity Scale Using Air Blast Stimulus | 5-minutes | 56 percentage of change in mean scores | Standard Deviation 25 |
| Colgate Sensitive Pro Relief | Percent Change in Mean Score of Pain Response From Baseline on Schiff Cold Air Sensitivity Scale Using Air Blast Stimulus | Day-3 | 24 percentage of change in mean scores | Standard Deviation 21 |
| Colgate Sensitive Pro Relief | Percent Change in Mean Score of Pain Response From Baseline on Schiff Cold Air Sensitivity Scale Using Air Blast Stimulus | Week-4 | 55 percentage of change in mean scores | Standard Deviation 24 |
| Colgate Sensitive Pro Relief | Percent Change in Mean Score of Pain Response From Baseline on Schiff Cold Air Sensitivity Scale Using Air Blast Stimulus | 1- minute | 45 percentage of change in mean scores | Standard Deviation 24 |
| Sensodyne Rapid Action | Percent Change in Mean Score of Pain Response From Baseline on Schiff Cold Air Sensitivity Scale Using Air Blast Stimulus | Day-3 | 25 percentage of change in mean scores | Standard Deviation 21 |
| Sensodyne Rapid Action | Percent Change in Mean Score of Pain Response From Baseline on Schiff Cold Air Sensitivity Scale Using Air Blast Stimulus | 5-minutes | 51 percentage of change in mean scores | Standard Deviation 28 |
| Sensodyne Rapid Action | Percent Change in Mean Score of Pain Response From Baseline on Schiff Cold Air Sensitivity Scale Using Air Blast Stimulus | Week-4 | 45 percentage of change in mean scores | Standard Deviation 25 |
| Sensodyne Rapid Action | Percent Change in Mean Score of Pain Response From Baseline on Schiff Cold Air Sensitivity Scale Using Air Blast Stimulus | 1- minute | 37 percentage of change in mean scores | Standard Deviation 27 |
| Colgate Total | Percent Change in Mean Score of Pain Response From Baseline on Schiff Cold Air Sensitivity Scale Using Air Blast Stimulus | Week-4 | 22 percentage of change in mean scores | Standard Deviation 24 |
| Colgate Total | Percent Change in Mean Score of Pain Response From Baseline on Schiff Cold Air Sensitivity Scale Using Air Blast Stimulus | 5-minutes | 19 percentage of change in mean scores | Standard Deviation 21 |
| Colgate Total | Percent Change in Mean Score of Pain Response From Baseline on Schiff Cold Air Sensitivity Scale Using Air Blast Stimulus | 1- minute | 15 percentage of change in mean scores | Standard Deviation 22 |
| Colgate Total | Percent Change in Mean Score of Pain Response From Baseline on Schiff Cold Air Sensitivity Scale Using Air Blast Stimulus | Day-3 | 10 percentage of change in mean scores | Standard Deviation 18 |
Comparison: It was calculated that 140 participants randomized in a 1:1:1:1 fashion between the four arms would have at least 80 % power to detect a difference of 0.20 mean scores between four treatments from baseline to week 4. Sample size was determined using PAS V.11, two independent sample t-test with 95% confidence interval.p-value: <0.05ANOVA
p-value: <0.05ANOVA
p-value: <0.05ANOVA
Secondary
Percent Change in Mean Scores of Pain Response From Baseline on Visual Analog Scale Using Mechanical Stimulus
Visual Analogue Scale was used to measure the intensity of pain due to dentin hypersensitivity using mechanical stimulus. Patient's response of pain was assessed on vertical line of 0 to 10cm by asking him to move finger on the line and stop it where he felt pain. Score range from; 0 (no pain at 0cm), 1(mild pain at 1cm), 2(mild pain at 2cm), 3(mild pain at 3cm), 4(moderate pain at 4cm), 5(moderate pain at 5cm), 6(moderate pain at 6cm), 7(severe pain at 7cm), 8(severe pain at 8cm), 9(severe pain at 9cm),10(worst imaginable pain at 10cm). Percent change in mean scores = (one minute score-Baseline score) / Baseline score
Time frame: (Base line to 1 minute) (Base line to 5 minutes)(Base line to day 3)(Base line to week 4)
Population: 35 individuals per treatment group were recruited and enrolled in the study after clinical diagnosis of dentin hypersensitivity using air blast stimulus and SCHIFF cold air sensitivity scale. These participants were tested again for dentin hypersensitivity using mechanical stimulus and Visual Analogue Scale. Statistical analysis was performed for 20 participants out of 32 per group with visual Analogue Scale score of ≥4.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BioMin F | Percent Change in Mean Scores of Pain Response From Baseline on Visual Analog Scale Using Mechanical Stimulus | 1-minute | 25 percentage of change in mean scores | Standard Deviation 22 |
| BioMin F | Percent Change in Mean Scores of Pain Response From Baseline on Visual Analog Scale Using Mechanical Stimulus | 5-minutes | 27 percentage of change in mean scores | Standard Deviation 23 |
| BioMin F | Percent Change in Mean Scores of Pain Response From Baseline on Visual Analog Scale Using Mechanical Stimulus | Day-3 | 28 percentage of change in mean scores | Standard Deviation 15 |
| BioMin F | Percent Change in Mean Scores of Pain Response From Baseline on Visual Analog Scale Using Mechanical Stimulus | Week-4 | 59 percentage of change in mean scores | Standard Deviation 27 |
| Colgate Sensitive Pro Relief | Percent Change in Mean Scores of Pain Response From Baseline on Visual Analog Scale Using Mechanical Stimulus | 5-minutes | 61 percentage of change in mean scores | Standard Deviation 26 |
| Colgate Sensitive Pro Relief | Percent Change in Mean Scores of Pain Response From Baseline on Visual Analog Scale Using Mechanical Stimulus | Day-3 | 38 percentage of change in mean scores | Standard Deviation 20 |
| Colgate Sensitive Pro Relief | Percent Change in Mean Scores of Pain Response From Baseline on Visual Analog Scale Using Mechanical Stimulus | Week-4 | 66 percentage of change in mean scores | Standard Deviation 27 |
| Colgate Sensitive Pro Relief | Percent Change in Mean Scores of Pain Response From Baseline on Visual Analog Scale Using Mechanical Stimulus | 1-minute | 56 percentage of change in mean scores | Standard Deviation 27 |
| Sensodyne Rapid Action | Percent Change in Mean Scores of Pain Response From Baseline on Visual Analog Scale Using Mechanical Stimulus | Day-3 | 32 percentage of change in mean scores | Standard Deviation 20 |
| Sensodyne Rapid Action | Percent Change in Mean Scores of Pain Response From Baseline on Visual Analog Scale Using Mechanical Stimulus | 5-minutes | 51 percentage of change in mean scores | Standard Deviation 27 |
| Sensodyne Rapid Action | Percent Change in Mean Scores of Pain Response From Baseline on Visual Analog Scale Using Mechanical Stimulus | Week-4 | 57 percentage of change in mean scores | Standard Deviation 27 |
| Sensodyne Rapid Action | Percent Change in Mean Scores of Pain Response From Baseline on Visual Analog Scale Using Mechanical Stimulus | 1-minute | 46 percentage of change in mean scores | Standard Deviation 26 |
| Colgate Total | Percent Change in Mean Scores of Pain Response From Baseline on Visual Analog Scale Using Mechanical Stimulus | Week-4 | 27 percentage of change in mean scores | Standard Deviation 16 |
| Colgate Total | Percent Change in Mean Scores of Pain Response From Baseline on Visual Analog Scale Using Mechanical Stimulus | 5-minutes | 20 percentage of change in mean scores | Standard Deviation 13 |
| Colgate Total | Percent Change in Mean Scores of Pain Response From Baseline on Visual Analog Scale Using Mechanical Stimulus | 1-minute | 16 percentage of change in mean scores | Standard Deviation 13 |
| Colgate Total | Percent Change in Mean Scores of Pain Response From Baseline on Visual Analog Scale Using Mechanical Stimulus | Day-3 | 18 percentage of change in mean scores | Standard Deviation 12 |
Comparison: It was calculated that 140 participants randomized in a 1:1:1:1 fashion between the four arms would have at least 80 % power to detect a difference of 0.20 mean scores between four treatments from baseline to week 4. Sample size was determined using PAS V.11, two independent sample t-test with 95% confidence interval.p-value: <0.05ANCOVA
p-value: <0.05ANOVA
p-value: <0.05ANOVA
Secondary
Percent Change in Mean Scores of Pain Response From Baseline on Visual Analog Scale Using Water Jet Stimulus
Visual Analogue Scale was used to measure the intensity of pain due to dentin hypersensitivity using Water Jet Stimulus. Patient's response of pain was assessed on vertical line of 0 to 10cm by asking him to move finger on the line and stop it where he felt pain. Score range from; 0 (no pain at 0cm), 1(mild pain at 1cm), 2(mild pain at 2cm), 3(mild pain at 3cm), 4(moderate pain at 4cm), 5(moderate pain at 5cm), 6(moderate pain at 6cm), 7(severe pain at 7cm), 8(severe pain at 8cm), 9(severe pain at 9cm),10(worst imaginable pain at 10cm). Percent change in mean scores = (one minute score-Baseline score) / Baseline score
Time frame: (Base line to 1 minute) (Base line to 5 minutes)(Base line to day 3)(Base line to week 4)
Population: 35 individuals per treatment group were recruited and enrolled in the study after clinical diagnosis of dentin hypersensitivity using air blast stimulus and SCHIFF cold air sensitivity scale. These participants were tested again for dentin hypersensitivity using water jet stimulus and Visual Analogue Scale. Statistical analysis was performed for 20 participants out of 32 with Visual Analogue Scale score of ≥4.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BioMin F | Percent Change in Mean Scores of Pain Response From Baseline on Visual Analog Scale Using Water Jet Stimulus | 1-minute | 22 percentage of change in mean scores | Standard Deviation 21 |
| BioMin F | Percent Change in Mean Scores of Pain Response From Baseline on Visual Analog Scale Using Water Jet Stimulus | 5-minutes | 27 percentage of change in mean scores | Standard Deviation 22 |
| BioMin F | Percent Change in Mean Scores of Pain Response From Baseline on Visual Analog Scale Using Water Jet Stimulus | Day-3 | 30 percentage of change in mean scores | Standard Deviation 29 |
| BioMin F | Percent Change in Mean Scores of Pain Response From Baseline on Visual Analog Scale Using Water Jet Stimulus | Week-4 | 67 percentage of change in mean scores | Standard Deviation 25 |
| Colgate Sensitive Pro Relief | Percent Change in Mean Scores of Pain Response From Baseline on Visual Analog Scale Using Water Jet Stimulus | 5-minutes | 56 percentage of change in mean scores | Standard Deviation 25 |
| Colgate Sensitive Pro Relief | Percent Change in Mean Scores of Pain Response From Baseline on Visual Analog Scale Using Water Jet Stimulus | Day-3 | 34 percentage of change in mean scores | Standard Deviation 22 |
| Colgate Sensitive Pro Relief | Percent Change in Mean Scores of Pain Response From Baseline on Visual Analog Scale Using Water Jet Stimulus | Week-4 | 57 percentage of change in mean scores | Standard Deviation 23 |
| Colgate Sensitive Pro Relief | Percent Change in Mean Scores of Pain Response From Baseline on Visual Analog Scale Using Water Jet Stimulus | 1-minute | 52 percentage of change in mean scores | Standard Deviation 26 |
| Sensodyne Rapid Action | Percent Change in Mean Scores of Pain Response From Baseline on Visual Analog Scale Using Water Jet Stimulus | Day-3 | 32 percentage of change in mean scores | Standard Deviation 21 |
| Sensodyne Rapid Action | Percent Change in Mean Scores of Pain Response From Baseline on Visual Analog Scale Using Water Jet Stimulus | 5-minutes | 52 percentage of change in mean scores | Standard Deviation 24 |
| Sensodyne Rapid Action | Percent Change in Mean Scores of Pain Response From Baseline on Visual Analog Scale Using Water Jet Stimulus | Week-4 | 55 percentage of change in mean scores | Standard Deviation 22 |
| Sensodyne Rapid Action | Percent Change in Mean Scores of Pain Response From Baseline on Visual Analog Scale Using Water Jet Stimulus | 1-minute | 46 percentage of change in mean scores | Standard Deviation 25 |
| Colgate Total | Percent Change in Mean Scores of Pain Response From Baseline on Visual Analog Scale Using Water Jet Stimulus | Week-4 | 29 percentage of change in mean scores | Standard Deviation 20 |
| Colgate Total | Percent Change in Mean Scores of Pain Response From Baseline on Visual Analog Scale Using Water Jet Stimulus | 5-minutes | 21 percentage of change in mean scores | Standard Deviation 17 |
| Colgate Total | Percent Change in Mean Scores of Pain Response From Baseline on Visual Analog Scale Using Water Jet Stimulus | 1-minute | 18 percentage of change in mean scores | Standard Deviation 15 |
| Colgate Total | Percent Change in Mean Scores of Pain Response From Baseline on Visual Analog Scale Using Water Jet Stimulus | Day-3 | 18 percentage of change in mean scores | Standard Deviation 16 |
Comparison: It was calculated that 140 participants randomized in a 1:1:1:1 fashion between the four arms would have at least 80 % power to detect a difference of 0.20 mean scores between four treatments from baseline to week 4. Sample size was determined using PAS V.11, two independent sample t-test with 95% confidence interval.p-value: <0.05ANCOVA
p-value: <0.05ANOVA
p-value: <0.05ANOVA