NUPRO Sensodyne Prophylaxis Paste With NovaMin Sensitivity Relief Study
NCT ID: NCT01669785
Last Updated: 2014-08-21
Study Results
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View full resultsBasic Information
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COMPLETED
NA
139 participants
INTERVENTIONAL
2012-03-31
2012-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Group C
NUPRO Classic Prophy Paste
Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains no Novamin or Fluoride..
Leave in contact for 60 seconds, rinse with water and expectorate.
Group C
Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth.
Group A
NUPRO Sensodyne Prophy Paste w/ Novamin
Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains 15% Novamin. Does not contain Fluoride.
Leave in contact for 60 seconds, rinse with water and expectorate
Group B
Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth.
Group B
NUPRO Sensodyne Prophy Paste w/ Novamin w/ Fluoride
Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains 1.23% fluoride ion and 15% Novamin.
Leave in contact for 60 seconds, rinse with water and expectorate.
Group A
Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth.
Interventions
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Group C
Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth.
Group A
Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth.
Group B
Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
70 Years
ALL
Yes
Sponsors
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Dentsply International
INDUSTRY
Responsible Party
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Principal Investigators
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Jeffrey L Milleman, DDS, MPA
Role: PRINCIPAL_INVESTIGATOR
Salus Research
Locations
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Salus Research, Inc.
Fort Wayne, Indiana, United States
Countries
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Other Identifiers
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CTP-002
Identifier Type: -
Identifier Source: org_study_id
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