NUPRO(r) Sensodyne Prophylaxis Paste With NovaMin(r)Sensitivity Relief Study
1 other identifier
interventional
151
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2011
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2011
CompletedFirst Submitted
Initial submission to the registry
May 30, 2012
CompletedFirst Posted
Study publicly available on registry
June 1, 2012
CompletedResults Posted
Study results publicly available
October 14, 2013
CompletedOctober 14, 2013
August 1, 2013
3 months
May 30, 2012
February 20, 2013
August 8, 2013
Conditions
Outcome Measures
Primary Outcomes (3)
Immediate Sensitivity Relief. Tactile Sensitivity.
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.
Immediately after treatment.
Adverse Events.
Assessment of adverse events that may occur as a result of treatment (typically includes any kind of allergic reation to paste).
Immediately after treatment to 28 days (+/- 2 days) post treatment.
Immediate Sensitivity Relief. Air Blast Sensitivity.
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.
Immediately after treatment.
Secondary Outcomes (2)
Extended Sensitivity Relief. Tactile Sensitivity.
28 days (+/- 2 days) post treatment.
Extended Sensitivity Relief. Air Blast Sensitivity.
28 days (+/- 2 days) post treatment.
Study Arms (3)
NUPRO(r) Classic Prophy Paste
ACTIVE COMPARATORNUPRO Sensodyne Prophy Paste w/ Novamin(r) w/ fluoride.
EXPERIMENTALNUPRO Sensodyne Prophy Paste w/ Novamin
EXPERIMENTALInterventions
Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth.
Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth.
Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Salus Research
Fort Wayne, Indiana, 46825, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Jeffery L. Milleman, DDS, MPA
- Organization
- Salus Research, Inc.
Study Officials
- PRINCIPAL INVESTIGATOR
Jeffery L. Milleman, DDS, MPA
Salus Research
- PRINCIPAL INVESTIGATOR
Kimberly R. Milleman, ASDH, MS
Salus Research
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 30, 2012
First Posted
June 1, 2012
Study Start
September 1, 2011
Primary Completion
December 1, 2011
Study Completion
December 1, 2011
Last Updated
October 14, 2013
Results First Posted
October 14, 2013
Record last verified: 2013-08