Skip to main content
OpenTrials
Completed

NCT Number: NCT01827670

Investigating the Efficacy of a Dentifrice in Providing Long Term Relief From Dentinal Hypersensitivity

Clinical studies have demonstrated long term relief from dentine hypersensitivity with twice daily brushing of a toothpaste containing stannous fluoride in comparison to marketed (negative) controls. The aim of this study is to evaluate the effectiveness of a stannous fluoride dentifrice in the treatment of dentinal hypersensitivity compared to a marketed (negative) control, over a period of 56 days (8 weeks) with twice daily brushing.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Dentine Hypersensitivity Dentin Sensitivity Stomatognathic Diseases Tooth Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Salus Research, Inc.

Fort Wayne, Indiana, 46825, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Participants with self-reported history of dentinal hypersensitivity lasting more than 6 months but not more than 10 years.
  • Participants with minimum of 20 natural teeth.
  • At screening, a minimum of two accessible teeth (incisors, canines, premolars) that meet all of the following criteria.
  • Teeth showing signs of facial/cervical gingival recession and/or signs of erosion or abrasion.
  • Teeth with Gingival Index score ≤1 and a clinical mobility of ≤1.
  • Teeth that are determined to be sensitive by the subject following a 1 second air blast to the cervical margin.

Exclusion criteria

  • Presence of chronic debilitating disease which, in the opinion of the investigator, could affect study outcomes.
  • Any condition which, in the opinion of the investigator, causes dry mouth.
  • Tooth with evidence of current or recent caries, or reported treatment of decay in 12 months of screening.
  • Participant using of a desensitising dentifrice within 6 weeks of screening

Treatment and study plan

Stannous Fluoride

Drug

Test dentifrice containing 0.454% SnF

Sodium Monofluorophosphate

Drug

Control dentifrice containing 0.76% w/w Sodium Monofluorophosphate [1000 parts per million (ppm) fluoride]

Primary outcomes

  1. Mean Change From Baseline in Schiff Sensitivity Score

    Time frame: Baseline-Week 8

    The examiner conducted the evaporative air sensitivity assessment and scored the subject's response to the sensitivity stimulus using the four-point categorical Schiff Sensitivity Scale (SSS).

    Score 0 = Subject does not respond to air stimulus Score 1 = Subject responds to air stimulus, but does not request discontinuation of stimulus Score 2 = Subject responds to air stimulus, and requests discontinuation or moves from stimulus Score 3 = Subject responds to air stimulus, considers stimulus to be painful, and requests discontinuation

Secondary outcomes

  1. Mean Change From Baseline in Schiff Sensitivity Score

    Time frame: Baseline-Week 4

    The examiner conducted the evaporative air sensitivity assessment and scored the subject's response to the sensitivity stimulus using the four-point categorical Schiff Sensitivity Scale (SSS).

    Score 0 = Subject does not respond to air stimulus Score 1 = Subject responds to air stimulus, but does not request discontinuation of stimulus Score 2 = Subject responds to air stimulus, and requests discontinuation or moves from stimulus Score 3 = Subject responds to air stimulus, considers stimulus to be painful, and requests discontinuation

  2. Mean Change From Baseline in Tactile Sensitivity

    Time frame: Baseline-Week 8

    The examiner assessed the tactile sensitivity of eligible teeth using a Yeaple probe. The constant pressure applied by Yeaple probe probe allowed the examiner to vary the force applied to the dentin surface from 10g to an upper threshold of 80g, in increments of 10g. The greater the pressure the participant was able to tolerate, the less sensitive the tooth was considered. Testing began at 10g and increased by 10g, with each successive challenge, until either a "yes" response (pain was elicited) was recorded or the maximum force has been reached.

  3. Mean Change From Baseline in Tactile Sensitivity

    Time frame: Baseline-Week 4

    The examiner assessed the tactile sensitivity of eligible teeth using a Yeaple probe. The constant pressure applied by Yeaple probe probe allowed the examiner to vary the force applied to the dentin surface from 10g to an upper threshold of 80g, in increments of 10g. The greater the pressure the participant was able to tolerate, the less sensitive the tooth was considered. Testing began at 10g and increased by 10g, with each successive challenge, until either a "yes" response (pain was elicited) was recorded or the maximum force has been reached.

  4. Mean Change in Dentinal Hypersensitivity After 4 Weeks as Measured by Visual Analog Scale (VAS)

    Time frame: Baseline-Week 4

    The subject rated the intensity of their response to the evaporative air stimulus by rating the intensity of their response to the stimulus using a 100 millimeter (mm )VAS Scale 0 is No Pain and 100 is Worst Pain Imaginable A trained member of staff measured the line segment marked off in mm and recorded this measurement in the CRF

  5. Mean Change in Dentinal Hypersensitivity After 8 Weeks as Measured by Visual Analog Scale (VAS)

    Time frame: Baseline - Week 8

    The subject rated the intensity of their response to the evaporative air stimulus by rating the intensity of their response to the stimulus using a 100 millimeter (mm )VAS Scale 0 is No Pain and 100 is Worst Pain Imaginable A trained member of staff measured the line segment marked off in mm and recorded this measurement in the CRF

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

A Clinical Study Investigating the Efficacy of a Dentifrice in Providing Long Term Relief From Dentinal Hypersensitivity

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Apr 9, 2013
Registry last updated
Jan 26, 2015

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.