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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
Sponsor:
Information provided by (Responsible Party):
Syed Jaffar Abbas Zaidi, Dow University of Health Sciences

Study Description
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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


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

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.
Study Design
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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy

Arms and Interventions
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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.
 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.
 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.
 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.
 Drug: Sodium Fluoride
No claim of relieving Dentin Hypersensitivity
Other Name: Colgate Total TM


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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

    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

  10. 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

    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

  11. 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

    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

  12. 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

    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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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


Contacts
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Contact: Dr Syed Jaffar Abbas Zaidi, MD, MFDS 03412481371 jaffar.zaidi@duhs.edu.pk

Locations
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Pakistan
Dr Syed Jaffar Abbas Zaidi Recruiting
Karachi, Sindh, Pakistan, 74600
Contact: Dr Syed Jaffar Abbas Zaidi         
Sponsors and Collaborators
Dow University of Health Sciences
Investigators
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Study Director: Syed Jaffar Abbas Zaidi Dow University of Health Sciences
More Information
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Publications:

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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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Syed Jaffar Abbas Zaidi, Dow University of Health Sciences:
Dentine hypersensitivity
Dentine Sensitivity
Oral dentifrices
Bio-active glasses
Additional relevant MeSH terms:
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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