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

Sponsor:

Information provided by (Responsible Party):

Syed Jaffar Abbas Zaidi, Dow University of Health Sciences

Study Description

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)
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

Drug Information available for: Sodium fluoride Listerine

U.S. FDA Resources

Arms and Interventions

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

Primary Outcome Measures :

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 :

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

Eligibility Criteria

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.

Contacts and Locations

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:

Study Protocol and Statistical Analysis Plan [PDF] September 7, 2019

Informed Consent Form [PDF] September 7, 2019

More Information

Publications:

Hall C, Mason S, Cooke J. Exploratory randomised controlled clinical study to evaluate the comparative efficacy of two occluding toothpastes - a 5% calcium sodium phosphosilicate toothpaste and an 8% arginine/calcium carbonate toothpaste - for the longer-term relief of dentine hypersensitivity. J Dent. 2017 May;60:36-43. doi: 10.1016/j.jdent.2017.02.009. Epub 2017 Feb 20.

Ashwini S, Swatika K, Kamala DN. Comparative Evaluation of Desensitizing Efficacy of Dentifrice Containing 5% Fluoro Calcium Phosphosilicate versus 5% Calcium Sodium Phosphosilicate: A Randomized Controlled Clinical Trial. Contemp Clin Dent. 2018 Jul-Sep;9(3):330-336. doi: 10.4103/ccd.ccd_735_17.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Arshad S, Zaidi SJA, Farooqui WA. Comparative efficacy of BioMin-F, Colgate Sensitive Pro-relief and Sensodyne Rapid Action in relieving dentin hypersensitivity: a randomized controlled trial. BMC Oral Health. 2021 Oct 6;21(1):498. doi: 10.1186/s12903-021-01864-x.

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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

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