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

Phase 3

Completed

Conditions: Dentin Hypersensitivity

Interventions: Drug: Fluoro-Calcium-Phospho-Silicate based dentifrices
Drug: 8% Arginine based dentifrices
Drug: 8% Strontium Acetate
Drug: Sodium Fluoride

Registration Number: NCT04249336

Lead Sponsor: Dow University of Health Sciences

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 140

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 & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BioMin F Dentifrices	Fluoro-Calcium-Phospho-Silicate based 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.
Colgate Sensitive Pro relief Trade Mark Dentifrices	8% Arginine based 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.
Sensodyne Rapid Action Trade Mark Dentifrices	8% Strontium Acetate	Participants will be instructed to dose a dry toothbrush with a full strip of dentifrices and to brush teeth for 1 minute twice daily.
Colgate Total Trade Mark	Sodium Fluoride	Participants will be instructed to dose a dry toothbrush with a full strip of dentifrices and to brush teeth for 1 minute twice daily.

Primary Outcome Measures

Name	Time	Method
Percent Change in Mean Score of Pain Response From Baseline on Schiff Cold Air Sensitivity Scale Using Air Blast Stimulus	(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

Name	Time	Method
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)	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	(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