Clinical Efficacy Of BioMin F, Colgate Sensitive Pro-Relief And Sensodyne Rapid Action Dentifrices In DH
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ClinicalTrials.gov Identifier: NCT04249336 |
Recruitment Status :
Recruiting
First Posted : January 30, 2020
Last Update Posted : January 5, 2021
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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
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Dentin Hypersensitivity | Drug: Fluoro-Calcium-Phospho-Silicate based dentifrices Drug: 8% Arginine based dentifrices Drug: 8% Strontium Acetate Drug: Sodium Fluoride | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 140 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
Masking Description: | Statistician will be masked. |
Primary Purpose: | Treatment |
Official Title: | Immediate And Sustained Treatment Response Of Commercially Available BioMin F, Colgate Sensitive Pro-Relief And Sensodyne Rapid Action Dentifrices In Dentin Hypersensitivity - "A Randomized Clinical Trial" |
Actual Study Start Date : | September 27, 2019 |
Estimated Primary Completion Date : | January 2021 |
Estimated Study Completion Date : | March 2021 |
Arm | Intervention/treatment |
---|---|
Experimental: 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.
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Drug: Fluoro-Calcium-Phospho-Silicate based dentifrices
Bio-Active glass based formulation
Other Name: BioMin F |
Active Comparator: 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.
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Drug: 8% Arginine based dentifrices
Tubular occluding formulation
Other Name: Colgate Sensitive Pro-Relief TM |
Active Comparator: 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.
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Drug: 8% Strontium Acetate
Tubular occluding formulation
Other Name: Sensodyne Rapid ActionTM |
Placebo Comparator: 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.
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Drug: Sodium Fluoride
No claim of relieving Dentin Hypersensitivity
Other Name: Colgate Total TM |
- Percentage Reduction from Baseline on VAS (Visual Analog Scale) with Mechanical Stimulus [ Time Frame: Base line to 60 seconds ]Patient's response to mechanical stimulus will be recorded on a Visual Analog Scale of 0-100 with 0 representing no pain and 100 representing the worst possible pain.
- Percentage Reduction from Baseline on VAS (Visual Analog Scale) with Mechanical Stimulus [ Time Frame: Base line to 5 minutes ]Patient's response to mechanical stimulus will be recorded on a Visual Analog Scale of 0-100 with 0 representing no pain and 100 representing the worst possible pain.
- Percentage Reduction from Baseline on VAS (Visual Analog Scale) with Mechanical Stimulus [ Time Frame: Base line to day 3 ]Patient's response to mechanical stimulus will be recorded on a Visual Analog Scale of 0-100 with 0 representing no pain and 100 representing the worst possible pain.
- Percentage Reduction from Baseline on VAS (Visual Analog Scale) with Mechanical Stimulus [ Time Frame: Base line to Week 4 ]Patient's response to mechanical stimulus will be recorded on a Visual Analog Scale of 0-100 with 0 representing no pain and 100 representing the worst possible pain.
- Percentage Reduction from Baseline on VAS (Visual Analog Scale) with Water Jet Stimulus [ Time Frame: Base line to 60 seconds ]Patient's response to water jet stimulus will be recorded on a Visual Analog Scale of 0-100 with 0 representing no pain and 100 representing the worst possible pain.
- Percentage Reduction from Baseline on VAS (Visual Analog Scale) with Water Jet Stimulus [ Time Frame: Base line to 5 minutes ]Patient's response to water jet stimulus will be recorded on a Visual Analog Scale of 0-100 with 0 representing no pain and 100 representing the worst possible pain.
- Percentage Reduction from Baseline on VAS (Visual Analog Scale) with Water Jet Stimulus [ Time Frame: Base line to day 3 ]Patient's response to water jet stimulus will be recorded on a Visual Analog Scale of 0-100 with 0 representing no pain and 100 representing the worst possible pain.
- Percentage Reduction from Baseline on VAS (Visual Analog Scale) with Water Jet Stimulus [ Time Frame: Base line to week 4 ]Patient's response to water jet stimulus will be recorded on a Visual Analog Scale of 0-100 with 0 representing no pain and 100 representing the worst possible pain.
- Percentage Reduction from Baseline on Schiff Cold Air Sensitivity Scale (SCASS) with Air Blast Stimulus [ Time Frame: Base line to 60 Seconds ]
Patient's response to Air Blast Stimulus will be recorded on SCHIFF COLD AIR SENSITIVITY SCALE (SCASS). This scale is coded from 0 to 3 and is observed by investigator as "0" for No response of pain
- Pain response but no request of discontinuity of stimulus
- Pain response with request of discontinuity of stimulus
- Immediate pain response for discontinuity of stimulus
- Percentage Reduction from Baseline on Schiff Cold Air Sensitivity Scale (SCASS) with Air Blast Stimulus [ Time Frame: Base line to 5 minutes ]
Patient's response to Air Blast Stimulus will be recorded on SCHIFF COLD AIR SENSITIVITY SCALE (SCASS). This scale is coded from 0 to 3 and is observed by investigator as "0" for No response of pain
- Pain response but no request of discontinuity of stimulus
- Pain response with request of discontinuity of stimulus
- Immediate pain response for discontinuity of stimulus
- Percentage Reduction from Baseline on Schiff Cold Air Sensitivity Scale (SCASS) with Air Blast Stimulus [ Time Frame: Base line to Day 3 ]
Patient's response to Air Blast Stimulus will be recorded on SCHIFF COLD AIR SENSITIVITY SCALE (SCASS). This scale is coded from 0 to 3 and is observed by investigator as "0" for No response of pain
- Pain response but no request of discontinuity of stimulus
- Pain response with request of discontinuity of stimulus
- Immediate pain response for discontinuity of stimulus
- Percentage Reduction from Baseline on Schiff Cold Air Sensitivity Scale (SCASS) with Air Blast Stimulus [ Time Frame: Base line to Week 4 ]
Patient's response to Air Blast Stimulus will be recorded on SCHIFF COLD AIR SENSITIVITY SCALE (SCASS). This scale is coded from 0 to 3 and is observed by investigator as "0" for No response of pain
- Pain response but no request of discontinuity of stimulus
- Pain response with request of discontinuity of stimulus
- Immediate pain response for discontinuity of stimulus

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Ages Eligible for Study: | 18 Years to 50 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04249336
Contact: Dr Syed Jaffar Abbas Zaidi, MD, MFDS | 03412481371 | jaffar.zaidi@duhs.edu.pk |
Pakistan | |
Dr Syed Jaffar Abbas Zaidi | Recruiting |
Karachi, Sindh, Pakistan, 74600 | |
Contact: Dr Syed Jaffar Abbas Zaidi |
Study Director: | Syed Jaffar Abbas Zaidi | Dow University of Health Sciences |
Responsible Party: | Syed Jaffar Abbas Zaidi, Principal investigator, Dow University of Health Sciences |
ClinicalTrials.gov Identifier: | NCT04249336 |
Other Study ID Numbers: |
PRS4072 |
First Posted: | January 30, 2020 Key Record Dates |
Last Update Posted: | January 5, 2021 |
Last Verified: | January 2021 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Dentine hypersensitivity Dentine Sensitivity Oral dentifrices Bio-active glasses |
Dentin Sensitivity Hypersensitivity Immune System Diseases Tooth Diseases Stomatognathic Diseases Listerine Calcium Fluorides |
Sodium Fluoride Calcium-Regulating Hormones and Agents Physiological Effects of Drugs Cariostatic Agents Protective Agents Anti-Infective Agents, Local Anti-Infective Agents |