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

Information source: Dentsply International
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Tooth Hypersensitivity

Intervention: NUPRO Classic Prophy Paste (Device); NUPRO Sensodyne Prophy Paste with Novamin with fluoride. (Device); NUPRO Sensodyne Prophy Paste with Novamin without fluoride. (Device)

Phase: N/A

Status: Completed

Sponsored by: Dentsply International

Official(s) and/or principal investigator(s):
Jeffery L. Milleman, DDS, MPA, Principal Investigator, Affiliation: Salus Research
Kimberly R. Milleman, ASDH, MS, Principal Investigator, Affiliation: Salus Research

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Primary outcome:

Immediate Sensitivity Relief. Tactile Sensitivity.

Adverse Events.

Immediate Sensitivity Relief. Air Blast Sensitivity.

Secondary outcome:

Extended Sensitivity Relief. Tactile Sensitivity.

Extended Sensitivity Relief. Air Blast Sensitivity.

Detailed description: 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.

Eligibility

Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Both.

Criteria:

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

- 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.

Locations and Contacts

Salus Research, Fort Wayne, Indiana 46825, United States
Additional Information

Starting date: September 2011
Last updated: August 8, 2013

Page last updated: August 20, 2015

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