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Clinical Efficacy Of BioMin F, Colgate Sensitive Pro-Relief And Sensodyne Rapid Action Dentifrices In DH

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04249336
Recruitment Status : Completed
First Posted : January 30, 2020
Results First Posted : May 11, 2021
Last Update Posted : May 11, 2021
Sponsor:
Information provided by (Responsible Party):
Syed Jaffar Abbas Zaidi, Dow University of Health Sciences

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.

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy

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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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



Information from the National Library of Medicine

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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.

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


Locations
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Pakistan
Dr Syed Jaffar Abbas Zaidi
Karachi, Sindh, Pakistan, 74600
Sponsors and Collaborators
Dow University of Health Sciences
Investigators
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Study Director: Syed Jaffar Abbas Zaidi Dow University of Health Sciences
  Study Documents (Full-Text)

Documents provided by Syed Jaffar Abbas Zaidi, Dow University of Health Sciences:
Informed Consent Form  [PDF] September 7, 2019

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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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
Results First Posted: May 11, 2021
Last Update Posted: May 11, 2021
Last Verified: April 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