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Completed

NCT Number: NCT01610167

NUPRO(r) Sensodyne Prophylaxis Paste With NovaMin(r)Sensitivity Relief Study

The study is intended to verify through clinical measurement that the NUPRO Sensodyne Prophylaxis Paste with Novamin provides immediate sensitivity relief as well as extended relief up to 28 days.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Salus Research

Fort Wayne, Indiana, 46825, United States

About this study

It is hypothesized that the prophy paste with NovaMin(r)will give patients immediate sensitivity relief, as well as sensitivity relief up to 4 weeks (28 days) after measurement.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Availability to complete in the 28 day duration of the study.
  • Two sensitive teeth which are not adjacent to each other and preferably in different quadrants and demonstrate cervical erosion, abrasion, and gingival recession.
  • qualifying response to tactile stimuli as defined by a score of </= 20 grams.
  • Qualifying response to air blast stimuli as defined by a score of >/= 1 on the Schiff Cold Air Sensitivity Scale.
  • Good general health with no known allergies to products being tested.
  • Use of a non-desensitizing dentifrice for 3 weeks prior to entry into the study.
  • Able to follow study procedures and instructions.
  • Must have a minimum of 10 natural evaluable teeth, excluding 3rd molars.

Exclusion criteria

  • Individuals who exhibit gross oral pathology
  • Females who may be pregnant or lactating or intending to become pregnant
  • Individuals who require anesthetic during scaling
  • Dental pathology which may cause pain similar to tooth sensitivity
  • Individuals with large amounts of calculus
  • Subjects with active infectious diseases such as hepatitis, HIV or tuberculosis
  • Any condition requiring antibiotic prophylaxis for dental treatment
  • Excessive gingival inflammation
  • Individuals who had their teeth cleaned within 30 days of the screening appointment
  • Individuals who have had a desensitizing treatment or tooth bleaching within 90 days of screening appointment.
  • Oral pathology, chronic disease, or history of allergy to test products
  • Advanced periodontal disease or treatment for periodontal disease (including surgery) within the past twelve months.
  • Sensitive teeth with mobility greater than one.
  • Teeth with extensive/defective restorations (including prosthetic crowns), suspected pulpitis, caries, cracked enamel, or used as abutments for removable partial dentures.
  • Regular use of sedatives, anti-inflammatory drugs, or analgesic
  • Participation in a desensitizing dentifrice study or regular use of a desensitizing dentifrice within the past 4 weeks.
  • Current participation in any other clinical study or receipt of an investigational drug within 30 days of the screening visit at the start of the study.
  • Personnel; a) An employee of the sponsor; b) A member or relative of the study site staff directly involved with the study.
  • Allergies to oral care products, personal care consumer products, or their ingredients.
  • Any subject who, in the judgment of the investigator, should not participate in the study.

Treatment and study plan

NUPRO Classic Prophy Paste

Device

Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth.

NUPRO Sensodyne Prophy Paste with Novamin with fluoride.

Device

Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth.

NUPRO Sensodyne Prophy Paste with Novamin without fluoride.

Device

Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth.

Primary outcomes

  1. Immediate Sensitivity Relief. Tactile Sensitivity.

    Time frame: Immediately after treatment.

    Assessment of sensitivity via tactile stimulation immediately after treatment. Tactile sensitivity measured using a Yeaple probe recording tactile pressure in grams before nerve stimulation. Point of nerve stimulation identified by patient with a "yes" response as pressure is increased in 10 gram increments. Tactile sensitivity is reported as the change from baseline after treatment.

  2. Adverse Events.

    Time frame: Immediately after treatment to 28 days (+/- 2 days) post treatment.

    Assessment of adverse events that may occur as a result of treatment (typically includes any kind of allergic reation to paste).

  3. Immediate Sensitivity Relief. Air Blast Sensitivity.

    Time frame: Immediately after treatment.

    Sensitivity measurements performed using a cold air blast and sensitivity scored on the four (4) point Schiff scale with 0 equal to no discomfort or awareness of sensitivity and 3 equal to severe pain from sensitive teeth. Score is reported as the change from baseline after treatment.

Secondary outcomes

  1. Extended Sensitivity Relief. Tactile Sensitivity.

    Time frame: 28 days (+/- 2 days) post treatment.

    Assessment of sensitivity score via tactile stimulation 28 days post treatment. Tactile sensitivity measured using a Yeaple probe recording tactile pressure in grams before nerve stimulation. Point of nerve stimulation identified by patient with "yes" response as pressure is increased in 10 gram increments. Measured sensitivity is reported as difference from baseline examination.

  2. Extended Sensitivity Relief. Air Blast Sensitivity.

    Time frame: 28 days (+/- 2 days) post treatment.

    Assessment of cold air sensitivity. Cold air sensitivity measurements performed using a cold air blast and sensitivity scored on the four (4) point Schiff scale with 0 equal to no discomfort or awareness of sensitivity and 3 equal to severe pain from sensitive teeth.

Sponsors and collaborators

Lead sponsor

Dentsply International

Industry

Registry information

Official study title

NUPRO(r) Sensodyne Prophylaxis Paste With NovaMin(r) for the Treatment of Dentin Hypersensitivity.

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Jun 1, 2012
Registry last updated
Oct 14, 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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