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Trial record 24 of 43 for:    FLUORIDE ION AND TRICLOSAN

The Efficacy of a Toothpaste to Reduce Sensitivity

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ClinicalTrials.gov Identifier: NCT00763269
Recruitment Status : Completed
First Posted : September 30, 2008
Results First Posted : September 17, 2010
Last Update Posted : March 7, 2012
Sponsor:
Information provided by (Responsible Party):
Colgate Palmolive

Brief Summary:
Hypersensitivity

Condition or disease Intervention/treatment Phase
Dentin Hypersensitivity Drug: Triclosan, Silicon dioxide, fluoride Drug: Triclosan, fluoride Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 626 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: The Efficacy of a Toothpaste to Reduce Sensitivity
Study Start Date : September 2008
Actual Primary Completion Date : December 2008
Actual Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy

Arm Intervention/treatment
Experimental: A
sensitive toothpaste
Drug: Triclosan, Silicon dioxide, fluoride
Brush twice daily

Active Comparator: B
Triclosan control toothpaste
Drug: Triclosan, fluoride
Brush twice daily




Primary Outcome Measures :
  1. Hypersensitivity Tactile(Yeaple Probe) [ Time Frame: 4 weeks ]
    Measured with an electronic force sensing probe (Yeaple Probe): 10, 20, 30, 40, up to 50 grams of force are applied to hypersensitive tooth until pain elicited. Grams of force needed to elicit pain are recorded as hypersensitivity score for the tooth. For Tactile Hypersensitivity: The higher the score (the more grams of force needed to elicit a response of pain), the lower the hypersensitivity. Hypersensitivity scores on a per study subject basis are recorded as mean scores of two hypersensitive teeth

  2. Hypersensitivity Tactile (Yeaple Probe) [ Time Frame: 8 weeks ]
    Measured with an electronic force sensing probe (Yeaple Probe): 10, 20, 30, 40, up to 50 grams of force are applied to hypersensitive tooth until pain elicited. Grams of force needed to elicit pain are recorded as hypersensitivity score for the tooth. For Tactile Hypersensitivity: The higher the score (the more grams of force needed to elicit a response of pain), the lower the hypersensitivity. Hypersensitivity scores on a per study subject basis are recorded as mean scores of two hypersensitive teeth


Secondary Outcome Measures :
  1. Air Blast Hypersensitivity (4 Week) [ Time Frame: 4 weeks ]
    Examiner rates the response to stimulation of hypersensitive teeth using a jet of air (constant stimulus on the basis of duration, pressure, temperature, distance from target). Response is rated based on the Schiff Cold Air Sensitivity Scale.This analog scale scores for the tooth is 0,1,2 or 3:"0"No subject response to stimulus"1"responds but will continue"2"responds and moves or requests discontinuation"3"Painful response to stimulus, discontinuation requested. The lower the score, the lower the hypersensitivity.Scores per study subject are recorded as mean scores of two hypersensitive teeth.

  2. Air Blast Hypersensitivity (8 Week) [ Time Frame: 8 weeks ]
    Examiner rates the response to stimulation of hypersensitive teeth using a jet of air (constant stimulus on the basis of duration, pressure, temperature, distance from target). Response is rated based on the Schiff Cold Air Sensitivity Scale.This analog scale scores for the tooth is 0,1,2 or 3:"0"No subject response to stimulus"1"responds but will continue"2"responds and moves or requests discontinuation"3"Painful response to stimulus, discontinuation requested. The lower the score, the lower the hypersensitivity.Scores per study subject are recorded as mean scores of two hypersensitive teeth.



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Ages Eligible for Study:   12 Years to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male and female subjects, ages: 12 years or older.
  • Availability for the eight-week duration of the study.
  • Two sensitive teeth, which must be anterior to the molars, and demonstrate cervical erosion/abrasion or gingival recession.
  • Qualifying response to Tactile stimuli (Yeaple Probe) as defined by a score between 10-50 grams of force.
  • Qualifying response to the Air Blast stimuli as defined by a score of 2 or 3 on the Schiff Cold Air Sensitivity Scale.
  • Subjects need to satisfy the qualifying response to stimuli for both parameters assessed (Tactile or Air Blast) on at least two teeth to be entered into the study.
  • Good general health with no known allergies to products being tested.
  • Use of a non-desensitizing dentifrice for one month prior to entry into the study.
  • Signed Informed Consent Form.

Exclusion Criteria:

  • Gross 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 a 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 anticonvulsants, antihistamines, sedatives, tranquilizers, anti-inflammatory drugs, or analgesics.
  • Participation in a desensitizing dentifrice study or regular use of a desensitizing dentifrice within the past one month.
  • Current participation in any other clinical study.
  • Allergies to triclosan, or oral care products, personal care consumer products, or their ingredients.
  • Medical condition which prohibits not eating/drinking for 4 hours.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00763269


Locations
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United States, New Jersey
Concordia Clinical Research
Cedar Knolls, New Jersey, United States, 08225
Sponsors and Collaborators
Colgate Palmolive
Investigators
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Principal Investigator: Augusto Elias, DDS Univ of Puerto Rico

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Responsible Party: Colgate Palmolive
ClinicalTrials.gov Identifier: NCT00763269     History of Changes
Other Study ID Numbers: CRO-0208-TOT-SEN-PR
First Posted: September 30, 2008    Key Record Dates
Results First Posted: September 17, 2010
Last Update Posted: March 7, 2012
Last Verified: June 2011
Additional relevant MeSH terms:
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Triclosan
Fluorides
Dentin Sensitivity
Hypersensitivity
Immune System Diseases
Tooth Diseases
Stomatognathic Diseases
Silicon
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs
Anti-Infective Agents, Local
Anti-Infective Agents
Fatty Acid Synthesis Inhibitors
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Trace Elements
Micronutrients
Nutrients
Growth Substances