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

NCT04249336 | Completed Phase 3 Results DMC

• 1 other identifier: PRS4072
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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

Conditions

Dentin Hypersensitivity

Keywords

Dentine hypersensitivity; Dentine Sensitivity; Oral dentifrices; Bio-active glasses

Outcome Measures

Primary Outcomes (1)

• Percent Change in Mean Score of Pain Response From Baseline on Schiff Cold Air Sensitivity Scale Using Air Blast Stimulus

  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 Outcomes (2)

• Percent Change in Mean Scores of Pain Response From Baseline on Visual Analog Scale Using Mechanical Stimulus

  (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

  (Base line to 1 minute) (Base line to 5 minutes)(Base line to day 3)(Base line to week 4)

Study Arms (4)

BioMin F Dentifrices

EXPERIMENTAL

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

Colgate Sensitive Pro relief Trade Mark Dentifrices

ACTIVE COMPARATOR

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

Sensodyne Rapid Action Trade Mark Dentifrices

ACTIVE COMPARATOR

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

Colgate Total Trade Mark

PLACEBO COMPARATOR

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

Interventions

Fluoro-Calcium-Phospho-Silicate based dentifrices DRUG

Bio-Active glass based formulation

Also known as: BioMin F

BioMin F Dentifrices

8% Arginine based dentifrices DRUG

Tubular occluding formulation

Also known as: Colgate Sensitive Pro-Relief TM

Colgate Sensitive Pro relief Trade Mark Dentifrices

8% Strontium Acetate DRUG

Tubular occluding formulation

Also known as: Sensodyne Rapid ActionTM

Sensodyne Rapid Action Trade Mark Dentifrices

Sodium Fluoride DRUG

No claim of relieving Dentin Hypersensitivity

Also known as: Colgate Total TM

Colgate Total Trade Mark

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dow University of Health Sciences: lead

Study Sites (1)

Dr Syed Jaffar Abbas Zaidi

Karachi, Sindh, 74600, Pakistan

Location

Related Publications (3)

• 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.

  PMID: 28219674 BACKGROUND

• 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.

  PMID: 30166822 BACKGROUND

• 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.

  PMID: 34615511 DERIVED

MeSH Terms

Conditions

Dentin Sensitivity

Interventions

strontium acetate; Sodium Fluoride

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Fluorides; Hydrofluoric Acid; Fluorine Compounds; Inorganic Chemicals; Sodium Compounds; Cariostatic Agents; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Results Point of Contact

• Title: Syed Jaffar Abbas Zaidi
• Organization: Dow University of Health Sciences

jaffar.zaidi@duhs.edu.pk

00923412481371

Study Officials

• Syed Jaffar Abbas Zaidi

  Dow University of Health Sciences

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Statistician will be masked.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: September 26, 2019
• First Posted: January 30, 2020
• Study Start: September 27, 2019
• Primary Completion: January 16, 2021
• Study Completion: January 16, 2021
• Last Updated: May 11, 2021
• Results First Posted: May 11, 2021

Record last verified: 2021-04

Locations

PA (1)