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Completed

NCT Number: NCT04249336

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

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

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Key information

Conditions

Dentin Hypersensitivity Dentin Sensitivity Stomatognathic Diseases Tooth Diseases

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Dr Syed Jaffar Abbas Zaidi

Karachi, Sindh, 74600, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Fluoro-Calcium-Phospho-Silicate based dentifrices

Drug

Bio-Active glass based formulation

Other names: BioMin F

8% Arginine based dentifrices

Drug

Tubular occluding formulation

Other names: Colgate Sensitive Pro-Relief TM

8% Strontium Acetate

Drug

Tubular occluding formulation

Other names: Sensodyne Rapid ActionTM

Sodium Fluoride

Drug

No claim of relieving Dentin Hypersensitivity

Other names: Colgate Total TM

Primary outcomes

  1. 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 outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

Dow University of Health Sciences

Other

Registry information

Official study 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"

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Jan 30, 2020
Registry last updated
May 11, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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