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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BioMin F Dentifrices | Experimental | Participants will be instructed to dose a dry toothbrush with a full strip of dentifrices and to brush teeth for 1 minute twice daily. |
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| Colgate Sensitive Pro relief Trade Mark Dentifrices | Active Comparator | Participants will be instructed to dose a dry toothbrush with a full strip of dentifrices and to brush teeth for 1 minute twice daily. |
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| Sensodyne Rapid Action Trade Mark Dentifrices | Active Comparator | Participants will be instructed to dose a dry toothbrush with a full strip of dentifrices and to brush teeth for 1 minute twice daily. |
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| Colgate Total Trade Mark | Placebo Comparator | Participants will be instructed to dose a dry toothbrush with a full strip of dentifrices and to brush teeth for 1 minute twice daily. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluoro-Calcium-Phospho-Silicate based dentifrices | Drug | Bio-Active glass based formulation |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 | (Base line to 1 minute) (Base line to 5 minutes)(Base line to day 3)(Base line to week 4) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Syed Jaffar Abbas Zaidi | Dow University of Health Sciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dr Syed Jaffar Abbas Zaidi | Karachi | Sindh | 74600 | Pakistan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28219674 | Background | Hall C, Mason S, Cooke J. Exploratory randomised controlled clinical study to evaluate the comparative efficacy of two occluding toothpastes - a 5% calcium sodium phosphosilicate toothpaste and an 8% arginine/calcium carbonate toothpaste - for the longer-term relief of dentine hypersensitivity. J Dent. 2017 May;60:36-43. doi: 10.1016/j.jdent.2017.02.009. Epub 2017 Feb 20. | |
| 30166822 |
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Of 380 assessed participants of self reported sensitivity in teeth, 140 met inclusion criteria and were randomized to treatment.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Colgate Sensitive Pro Relief | Participants received Colgate Sensitive Pro relief Trademark Dentifrices and instructed to brush their teeth with a full strip of dentifrices on a dry toothbrush for 1 minute twice daily for 4 weeks. Colgate Sensitive Pro relief Trade Mark Dentifrices : 8% Arginine and calcium carbonate, tubular occluding formulation |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 7, 2019 |
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Statistician will be masked.
| 8% Arginine based dentifrices | Drug | Tubular occluding formulation |
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| 8% Strontium Acetate | Drug | Tubular occluding formulation |
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| Sodium Fluoride | Drug | No claim of relieving Dentin Hypersensitivity |
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| (Base line to 1 minute) (Base line to 5 minutes)(Base line to day 3)(Base line to week 4) |
| 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 | (Base line to 1 minute) (Base line to 5 minutes)(Base line to day 3)(Base line to week 4) |
| Background |
| Ashwini S, Swatika K, Kamala DN. Comparative Evaluation of Desensitizing Efficacy of Dentifrice Containing 5% Fluoro Calcium Phosphosilicate versus 5% Calcium Sodium Phosphosilicate: A Randomized Controlled Clinical Trial. Contemp Clin Dent. 2018 Jul-Sep;9(3):330-336. doi: 10.4103/ccd.ccd_735_17. |
| 34615511 | Derived | Arshad S, Zaidi SJA, Farooqui WA. Comparative efficacy of BioMin-F, Colgate Sensitive Pro-relief and Sensodyne Rapid Action in relieving dentin hypersensitivity: a randomized controlled trial. BMC Oral Health. 2021 Oct 6;21(1):498. doi: 10.1186/s12903-021-01864-x. |
| FG001 |
| BioMin F |
Participants received BioMin F Dentifrices and instructed to brush their teeth with a full strip of dentifrices on a dry toothbrush for 1 minute twice daily for 4 weeks. BioMin F Dentifrices : Fluoro-Calcium-Phospho-Silicate, Bio-Active glass based tubular occluding formulation |
| FG002 | Sensodyne Rapid Action | Participants received Sensodyne Rapid Action dentifrices and instructed to brush their teeth with a full strip of dentifrices on a dry toothbrush for 1 minute twice daily for 4 weeks. Sensodyne Rapid Action Trademark Dentifrices : 8% Strontium Acetate with tubular occluding formulation. |
| FG003 | Colgate Total | Participants received Colgate Total dentifrices and instructed to brush their teeth with a full strip of dentifrices on a dry toothbrush for 1 minute twice daily for 4 weeks. Colgate Total Trademark Dentifrices : Sodium Fluoride with no claim of relieving Dentin Hypersensitivity |
| Per Protocol Population Day 3 |
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| Per Protocol Population Week 4 |
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| COMPLETED | Out of 35 participants per group, 32 completed the 4-week clinical trial after lost to follow up and statistically analyzed for primary outcome measure. |
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| NOT COMPLETED |
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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 and visual Analogue Scale score of ≥4.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | 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 |
| BG002 | 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 |
| BG003 | 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 |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Asian (Pakistani) population was studied in 4 week clinical trial. | Count of Participants | Participants | No |
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| Summary of the baseline SCHIFF cold air sensitivity scale for air blast stimulus response | 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 criteria; "0" for no response of pain, "1" for pain response but no request of discontinuity of stimulus, "2" for pain response with request of discontinuity of stimulus, "3" for Immediate pain response for discontinuity of stimulus | Total lost to follow up was 12 out of 140 enrolled participants. Lost to follow up per group was 3 out of 35. Statistical analysis was performed for 32 participants per group. | Mean | Standard Deviation | scores on a scale |
| ||||||||
| Summary of the baseline Visual Analog scale for Mechanical and Water jet stimulus response | Visual Analogue Scale was used to measure the intensity of pain due to dentin hypersensitivity using mechanical stimulus and 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. Scoring criteria for each cm was, 0cm for no pain with score 0, 1-3cm for mild pain with scores 1,2 and 3, 4-6cm for moderate pain with scores 4,5 and 6, 7-9cm for severe pain with scores 7,8 and 9 and 10cm for worst imaginable pain with score10. | Out of 35 participants per group, 20 participants responded on Visual Analogue Scale for DH in 4-week trial. | Mean | Standard Deviation | scores on a scale |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | 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. | Posted | Mean | Standard Deviation | percentage of change in mean scores | (Base line to 1 minute) (Base line to 5 minutes)(Base line to day 3)(Base line to week 4) |
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| 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 | 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. | Posted | Mean | Standard Deviation | percentage of change in mean scores | (Base line to 1 minute) (Base line to 5 minutes)(Base line to day 3)(Base line to week 4) |
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| 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 | 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. | Posted | Mean | Standard Deviation | percentage of change in mean scores | (Base line to 1 minute) (Base line to 5 minutes)(Base line to day 3)(Base line to week 4) |
|
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | BioMin F Dentifrices | Participants will be 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 | 0 | 35 | 0 | 35 | 0 | 35 |
| EG001 | Colgate Sensitive Pro Relief Trade Mark Dentifrices | Participants will be 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 | 0 | 35 | 0 | 35 | 0 | 35 |
| EG002 | Sensodyne Rapid Action Trade Mark Dentifrices | Participants will be 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 | 0 | 35 | 0 | 35 | 0 | 35 |
| EG003 | Colgate Total Trade Mark | Participants will be 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 | 0 | 35 | 0 | 35 | 0 | 35 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Syed Jaffar Abbas Zaidi | Dow University of Health Sciences | 00923412481371 | jaffar.zaidi@duhs.edu.pk |
| Mar 13, 2021 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 7, 2019 | Mar 13, 2021 | ICF_001.pdf |
| ID | Term |
|---|---|
| D003807 | Dentin Sensitivity |
| ID | Term |
|---|---|
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| C106741 | strontium acetate |
| D012969 | Sodium Fluoride |
| ID | Term |
|---|---|
| D005459 | Fluorides |
| D006858 | Hydrofluoric Acid |
| D017611 | Fluorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
| D002327 | Cariostatic Agents |
| D001697 | Biomedical and Dental Materials |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
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| Water Jet hypersensitivity baseline score |
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| 5-minutes |
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| Day-3 |
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| Week-4 |
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| ANOVA | <0.05 | Threshold P<0.05 | Mean Difference (Net) | 33 | 2-Sided | 95 | Treatment difference in percent = Colgate Sensitive Pro relief - Colgate Total | Superiority |
| ANOVA | <0.05 | Threshold for statistical significance was p <0.05. | Mean Difference (Net) | 23 | 2-Sided | 95 | Treatment difference in percent = Sensodyne Rapid Action - Colgate Total | Superiority |
| OG001 |
| Colgate Sensitive Pro Relief |
Participants received Colgate Sensitive Pro relief Trademark Dentifrices and instructed to brush their teeth with a full strip of dentifrices on a dry toothbrush for 1 minute twice daily for 4 weeks. Colgate Sensitive Pro relief Trade Mark Dentifrices : 8% Arginine and calcium carbonate, tubular occluding formulation |
| OG002 | Sensodyne Rapid Action | Participants received Sensodyne Rapid Action dentifrices and instructed to brush their teeth with a full strip of dentifrices on a dry toothbrush for 1 minute twice daily for 4 weeks. Sensodyne Rapid Action Trademark Dentifrices : 8% Strontium Acetate with tubular occluding formulation. |
| OG003 | Colgate Total | Participants received Colgate Total dentifrices and instructed to brush their teeth with a full strip of dentifrices on a dry toothbrush for 1 minute twice daily for 4 weeks. Colgate Total Trademark Dentifrices : Sodium Fluoride with no claim of relieving Dentin Hypersensitivity |
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| OG001 |
| Colgate Sensitive Pro Relief |
Participants received Colgate Sensitive Pro relief Trademark Dentifrices and instructed to brush their teeth with a full strip of dentifrices on a dry toothbrush for 1 minute twice daily for 4 weeks. Colgate Sensitive Pro relief Trade Mark Dentifrices : 8% Arginine and calcium carbonate, tubular occluding formulation |
| OG002 | Sensodyne Rapid Action | Participants received Sensodyne Rapid Action dentifrices and instructed to brush their teeth with a full strip of dentifrices on a dry toothbrush for 1 minute twice daily for 4 weeks. Sensodyne Rapid Action Trademark Dentifrices : 8% Strontium Acetate with tubular occluding formulation. |
| OG003 | Colgate Total | Participants received Colgate Total dentifrices and instructed to brush their teeth with a full strip of dentifrices on a dry toothbrush for 1 minute twice daily for 4 weeks. Colgate Total Trademark Dentifrices : Sodium Fluoride with no claim of relieving Dentin Hypersensitivity |
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