Clinical trial NCT04249336: Clinical Efficacy Of BioMin F, Colgate Sensitive Pro-Relief And Sensodyne Rapid Action Dentifrices In DH
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"
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Dentin Hypersensitivity
Keywords: Dentine hypersensitivity
Dentine Sensitivity
Oral dentifrices
Bio-active glasses
Lead sponsor: Dow University of Health Sciences
Sponsor class: OTHER
First posted: 2020-01-30
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Eligibility 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.

Primary outcomes:
measure: Percent Change in Mean Score of Pain Response From Baseline on Schiff Cold Air Sensitivity Scale Using Air Blast Stimulus
timeFrame: (Base line to 1 minute) (Base line to 5 minutes)(Base line to day 3)(Base line to week 4)
Secondary outcomes:
measure: Percent Change in Mean Scores of Pain Response From Baseline on Visual Analog Scale Using Mechanical Stimulus
timeFrame: (Base line to 1 minute) (Base line to 5 minutes)(Base line to day 3)(Base line to week 4)
measure: Percent Change in Mean Scores of Pain Response From Baseline on Visual Analog Scale Using Water Jet Stimulus
timeFrame: (Base line to 1 minute) (Base line to 5 minutes)(Base line to day 3)(Base line to week 4)
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Dr Syed Jaffar Abbas Zaidi
state: Sindh
Study officials:
affiliation: Dow University of Health Sciences
name: Syed Jaffar Abbas Zaidi
role: STUDY_DIRECTOR
References:
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.
citation: 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.
citation: 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.