NUPRO Sensodyne Prophylaxis Paste With NovaMin Sensitivity Relief Study

Dentsply International139 enrolled

Overview

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.

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

139

Conditions

Tooth Hypersensitivity

Interventions

Group CDEVICE

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

Group ADEVICE

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

Group BDEVICE

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Availability to complete in the 28 day duration. * Two sensitive teeth, which are not adjacent to each other and preferably in different quadrants, which 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. * Subjects need to satisfy the qualifying response to stimuli for both parameters assesses (Tactile or Air Blast) on at least two teeth (non-adjacent) to be entered into the study. * Good general health with no known allergies to products being tested. * Use of a non-desensitizing dentifrice for 2 weeks prior to entry into the study. * Subjects must have a minimum of 10 natural 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 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; b0 A member or relative of teh study site staff directly involved with the study.

Locations (1)

Salus Research, Inc.

Fort Wayne, Indiana, United States

Outcomes

Primary Outcomes

Baseline Pre-Prophy Assessment (Tactile Sensitivity)

Pre-prophy procedure baseline assessment is measured with an electronic force sensing probe (Yeaple probe). Grams of force needed to elicit pain are recorded as hypersensitivity score for the tooth. 10,20,30,40, up to 50 grams of force are applied to the hypersensitive tooth until pain is elicited. The higher the score (the more grams of force needed to elicit a response of pain), the lower the hypersensitiv Subjects were required to have two sensitive teeth which are not adjacent to each other and preferably in different quadrants. Scores were obtained by taking the average over the scores for the evaluated teeth.

Time frame: Pre-treatment measurement

Immediate Sensitivity Relief (Tactile Sensitivity)

Assessment of sensitivity score via tactile and air blast measurements immediately after treatment. Tactile hypersensitivity is measured with an electronic force sensing probel (Yeaple probe). Grams of force needed to elicit pain are recorded as hypersensitivity score for the tooth. Grams of force needed to elicit pain are recorded as hypersensitivity score for the tooth. 10, 20, 30, 40 up to 50 grams of force are applied to the hypersensitive tooth until pain is elicited. The higher the score (the more grams of force needed to elicit a response of pain), the lower the hypersensitivity. Subjects were required to have two sensitive teeth which are not adjacent to each other and preferably in different quadrants. Scores were obtained by taking the average over the scores for the evaluated teeth.

Time frame: Immediately after treatment .

Long-term Sensitivity Relief (Tactile Sensitivity)

Assessment of sensitivity score via tactile measurements long term after treatment. Tactile hypersensitivity is measured with an electronic force sensing probel (Yeaple probe). Grams of force needed to elicit pain are recorded as hypersensitivity score for the tooth. Grams of force needed to elicit pain are recorded as hypersensitivity score for the tooth. 10 to 50 grams of force are applied to the hypersensitive tooth until pain is elicited. The higher the score (the more grams of force needed to elicit a response of pain), the lower the hypersensitivity. Subjects were required to have two sensitive teeth which are not adjacent to each other and preferably in different quadrants. Scores were obtained by taking the average over the scores for the evaluated teeth.

Data from ClinicalTrials.gov

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Secondary Outcomes

Sensitivity Relief (Self-Assessment)

All subjects completed a questionnaire titled "How sensitive are your teeth?" to assess their whole-mouth tooth sensitivity prior to the baseline assessments. The questionnaire contained a 4-item verbal descriptor scale as follows: Score 0= no discomfort or awareness of sensitivity; 1=mild discomfort/pain from sensitive teeth; 2=moderate discomfort/pain from sensitive teeth; 3=severe pain from sensitive teeth. The higher the score, the higher the hypersensitivity. Subjects were required to have two sensitive teeth which are not adjacent to each other and preferably in different quadrants. Scores were obtained by taking the average over the scores for the evaluated teeth.

Time frame: Pre-Treatment

Post- Scaling Sensitivity Relief (Self-Assessment)

All subjects completed a questionnaire titled "How sensitive are your teeth?" to assess their whole-mouth tooth sensitivity immediately following the scaling procedure. The questionnaire contained a 4-item verbal descriptor scale as follows: Score 0= no discomfort or awareness of sensitivity; 1=mild discomfort/pain from sensitive teeth; 2=moderate discomfort/pain from sensitive teeth; 3=severe pain from sensitive teeth. The higher the score, the higher the hypersensitivity. Subjects were required to have two sensitive teeth which are not adjacent to each other and preferably in different quadrants. Scores were obtained by taking the average over the scores for the evaluated teeth.

Time frame: Post-scaling procedure,immediate

Post-prophylaxis Sensitivity Relief (Self-Assessment)

All subjects completed a questionnaire titled "How sensitive are your teeth?" to assess their whole-mouth tooth sensitivity immediately following the timed, 1-minute prophylaxis paste application. The questionnaire contained a 4-item verbal descriptor scale as follows: Score 0= no discomfort or awareness of sensitivity; 1=mild discomfort/pain from sensitive teeth;2=moderate discomfort/pain from sensitive teeth; 3=severe pain from sensitive teeth. The higher the score, the higher the hypersensitivity. Subjects were required to have two sensitive teeth which are not adjacent to each other and preferably in different quadrants. Scores were obtained by taking the average over the scores for the evaluated teeth.

Time frame: Immediately following post-prophylaxis treatment.

Long-term Sensitivity Relief (Self-Assessment)

All subjects completed a questionnaire titled "How sensitive are your teeth?" to assess their whole-mouth tooth sensitivity 28 days following prophylaxis treatment. The questionnaire contained a 4-item verbal descriptor scale as follows: Score 0= no discomfort or awareness of sensitivity;1=mild discomfort/pain from sensitive teeth; 2=moderate discomfort/pain from sensitive teeth; 3=severe pain from sensitive teeth. The higher the score, the higher the hypersensitivity. Subjects were required to have two sensitive teeth which are not adjacent to each other and preferably in different quadrants. Scores were obtained by taking the average over the scores for the evaluated teeth.

Time frame: 28 days post-prophylaxis treatment.