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

April 19, 2021 updated by: Syed Jaffar Abbas Zaidi, Dow University of Health Sciences

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"

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

140

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Sindh
      • Karachi, Sindh, Pakistan, 74600
        • Dr Syed Jaffar Abbas Zaidi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • Colgate Total TM

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
(Base line to 1 minute) (Base line to 5 minutes)(Base line to day 3)(Base line to week 4)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
(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
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
(Base line to 1 minute) (Base line to 5 minutes)(Base line to day 3)(Base line to week 4)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dow University of Health Sciences

Investigators

  • Study Director: Syed Jaffar Abbas Zaidi, Dow University of Health Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 27, 2019

Primary Completion (Actual)

January 16, 2021

Study Completion (Actual)

January 16, 2021

Study Registration Dates

First Submitted

September 26, 2019

First Submitted That Met QC Criteria

January 29, 2020

First Posted (Actual)

January 30, 2020

Study Record Updates

Last Update Posted (Actual)

May 11, 2021

Last Update Submitted That Met QC Criteria

April 19, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRS4072

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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