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

Dentin Hypersensitivity Clinical Trial

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"

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04249336
• Other study ID #: PRS4072
• Status: Completed
• Phase: Phase 3
• Start date: September 27, 2019
• Est. completion date: January 16, 2021

Study information

• Verified date: April 2021
• Source: Dow University of Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: January 16, 2021
• Est. primary completion date: January 16, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dentin Hypersensitivity
• Dentin Sensitivity
• Hypersensitivity

Intervention

Drug:
• Fluoro-Calcium-Phospho-Silicate based dentifrices
Bio-Active glass based formulation
• 8% Arginine based dentifrices
Tubular occluding formulation
• 8% Strontium Acetate
Tubular occluding formulation
• Sodium Fluoride
No claim of relieving Dentin Hypersensitivity

Locations

Country	Name	City	State
Pakistan	Dr Syed Jaffar Abbas Zaidi	Karachi	Sindh

Sponsors (1)

Lead Sponsor	Collaborator
Dow University of Health Sciences

Country where clinical trial is conducted

Pakistan, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Percent Change in Mean Scores of Pain Response From Baseline on Visual Analog Scale Using Mechanical Stimulus	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)
Secondary	Percent Change in Mean Scores of Pain Response From Baseline on Visual Analog Scale Using Water Jet Stimulus	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)