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 :
Completed
First Posted : January 30, 2020
Results First Posted : May 11, 2021
Last Update Posted : May 11, 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 |
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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) |
Actual 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 |
Actual Primary Completion Date : | January 16, 2021 |
Actual Study Completion Date : | January 16, 2021 |
Arm | Intervention/treatment |
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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 |
- Percent Change in Mean Score of Pain Response From Baseline on Schiff Cold Air Sensitivity Scale Using Air Blast Stimulus [ Time Frame: (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
- Percent Change in Mean Scores of Pain Response From Baseline on Visual Analog Scale Using Mechanical Stimulus [ Time Frame: (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 [ Time Frame: (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

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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
Pakistan | |
Dr Syed Jaffar Abbas Zaidi | |
Karachi, Sindh, Pakistan, 74600 |
Study Director: | Syed Jaffar Abbas Zaidi | Dow University of Health Sciences |
Documents provided by Syed Jaffar Abbas Zaidi, Dow University of Health Sciences:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 |
Results First Posted: | May 11, 2021 |
Last Update Posted: | May 11, 2021 |
Last Verified: | April 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 |