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Completed

NCT Number: NCT01494649

Pilot Study to Investigate the Efficacy of a Toothpaste in Providing Relief From Dentinal Hypersensitivity

A pilot study to determine the ability of a stannous fluoride containing toothpaste to provide immediate and short term relief from dentine Hypersensitivity compared to a control toothpaste.

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Key information

Conditions

Dentinal Sensitivity Hypersensitivity Immune System Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

BioSci Research America, Inc.

Las Vegas, Nevada, 89121, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion:

  • Self-reported history of dentinal hypersensitivity lasting more than 6 months and less than 10 years
  • Teeth showing signs of facial/cervical gingival recession and/or signs of erosion or abrasion.
  • Teeth having a gingival index score of less than or equal to 1
  • Teeth with a clinical mobility less than or equal to 1
  • sensitive teeth from those meeting the EAR, GI and mobility criteria at screening, with sensitivity as measured by tactile stimulus (Yeaple probe, tactile threshold 10g) and evaporative (air) stimulus (Schiff Sensitivity Score ≥ 2).

Exclusion:

  • Presence of chronic debilitating disease which could affect study outcomes.
  • Any condition which causes xerostomia.
  • Dental prophylaxis within 4 weeks of screening.
  • Tongue or lip piercing or presence of dental implants.
  • Professional desensitising treatment within 12 weeks of screening.
  • Gross periodontal disease, treatment of periodontal disease (including surgery) within 12 months of screening, scaling or root planning within 3 months of screening.
  • Teeth bleaching within 12 weeks of screening.
  • Tooth with evidence of current or recent caries, or reported treatment of decay in 12 months of screening.
  • Tooth with exposed dentine but with deep, defective or facial restorations, teeth used as abutments for fixed or removable partial dentures, teeth with full crowns or veneers, orthodontic bands or cracked enamel. Sensitive teeth with contributing aetiologies other than erosion, abrasion or recession of exposed dentine, or not expected to respond to treatment with an over-the counter dentifrice.
  • Daily doses of a medication which could interfere with the perception of pain.
  • Currently taking antibiotics or have taken antibiotics within 2 weeks of baseline.
  • Individuals who require antibiotic prophylaxis for dental procedures.

Treatment and study plan

test toothpaste

Drug

0.454% stannous fluoride toothpaste

Negative Control Toothpaste

Drug

0.76% sodium monofluorophosphate toothpaste

Primary outcomes

  1. Adjusted Mean Change From Baseline in Tooth Hypersensivity to Air Stimuli Immediately Following Treatment

    Time frame: Baseline and immediately after treatment administration

    Response to a constant (duration, pressure, temperature, distance from target) jet of air applied to a hypersensitive tooth was evaluated using Schiff Cold Air Sensitivity Scale. According to this analog scale hypersensitivity scores for the stimulated tooth is 0, 1, 2 or 3 (lower the score, lower the hypersensitivity).0= no response; 1= response and no discontinuation request; 2= response and discontinuation request; 3= painful response and discontinuation request. Change was calculated as Schiff score immediately after treatment minus Schiff score at baseline.

Secondary outcomes

  1. Adjusted Mean Change From Baseline in Tooth Hypersensitivity to Air Stimuli at Day 3

    Time frame: Baseline and Day 3

    Response to a constant (duration, pressure, temperature, distance from target) jet of air applied to a hypersensitive tooth evaluated using Schiff Cold Air Sensitivity Scale. According to this analog scale hypersensitivity scores for the stimulated tooth is 0, 1, 2 or 3 (lower the score, lower the hypersensitivity). 0=No participant response to stimulus, 1=responds but will continue, 2=responds and moves or requests discontinuation, 3=Painful response to stimulus, discontinuation requested. Change was Schiff score on Day 3 minus Schiff score at baseline.

  2. Adjusted Mean Change From Baseline in Tooth Hypersensitivity to Air Stimuli at Day 14

    Time frame: Baseline and Day 14

    Response to a constant (duration, pressure, temperature, distance from target) jet of air applied to a hypersensitive tooth evaluated using Schiff Cold Air Sensitivity Scale. According to this analog scale hypersensitivity scores for the stimulated tooth is 0, 1, 2 or 3 (lower the score, lower the hypersensitivity). 0=No participant response to stimulus, 1=responds but will continue, 2=responds and moves or requests discontinuation, 3=Painful response to stimulus, discontinuation requested. Change was Schiff score on Day 14 minus Schiff score at baseline.

  3. Adjusted Mean Change From Baseline in Tooth Hypersensitity to Touch Stimuli (Tactile) Immediately After Treatment

    Time frame: Baseline and immediately after treatment administration

    Measured with an electronic force sensing probe (Yeaple Probe): 10, 20, 30, 40, up to 80 grams of force applied to hypersensitive tooth until pain was elicited. Grams of force needed to elicit pain was recorded as hypersensitivity score for the tooth. The higher the score, the lower the hypersensitivity. Hypersensitivity scores on a per study participant basis was recorded as mean scores of all hypersensitive teeth. Change was calculated as mean score immediately after treatment minus mean score at baseline.

  4. Adjusted Mean Change From Baseline in Tooth Hypersensitity to Touch Stimuli (Tactile) Immediately at Day 3

    Time frame: Baseline and Day 3

    Measured with an electronic force sensing probe (Yeaple Probe): 10, 20, 30, 40, up to 80 grams of force applied to hypersensitive tooth until pain was elicited. Grams of force needed to elicit pain was recorded as hypersensitivity score for the tooth. The higher the score, the lower the hypersensitivity. Hypersensitivity scores on a per study participant basis was recorded as mean scores of all hypersensitive teeth. Change was calculated as mean score at Day 3 minus mean score at baseline.

  5. Adjusted Mean Change From Baseline in Tooth Hypersensitity to Touch Stimuli (Tactile) Immediately at Day 14

    Time frame: Baseline and Day 14

    Measured with an electronic force sensing probe (Yeaple Probe): 10, 20, 30, 40, up to 80 grams of force applied to hypersensitive tooth until pain was elicited. Grams of force needed to elicit pain was recorded as hypersensitivity score for the tooth. The higher the score, the lower the hypersensitivity. Hypersensitivity scores on a per study participant basis was recorded as mean scores of all hypersensitive teeth. Change was calculated as mean score at Day 14 minus mean score at baseline.

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

A Pilot Clinical Study Investigating the Efficacy of a Toothpaste in Providing Immediate and Short Term Relief From Dentinal Hypersensitivity

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Dec 19, 2011
Registry last updated
May 8, 2013

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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