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Effects of DIammine SIlver Fluoride on Tooth Sensitivity

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01063530
Recruitment Status : Unknown
Verified February 2010 by Universidad Peruana Cayetano Heredia.
Recruitment status was:  Not yet recruiting
First Posted : February 5, 2010
Last Update Posted : February 5, 2010
University of Washington
Information provided by:
Universidad Peruana Cayetano Heredia

Brief Summary:

The purpose of the study is to confirm the clinical effectiveness and safety of topical diammine silver fluoride (DASF) as a tooth desensitizer in adulst by comparing it to the application of sterile water.

The study will be conducted in two different sites in Peru. Participantes will be 144 adults who will have at least one vital maxillary or mandibular cuspid or premolar with a cervical defect on the buccal surface and clinical hypersensitivity in response to air. Subjects will be randomly assigned to a topical application of DAS or sterile water.

The reduction of pain (sensitivity) using a 100 mm VAS, will be determined. Safety will be also determined by evaluating the gingival condition (erythema, white changes, ulceration, staining) before and ater the application of the products. The evaluation times will be 24 hours and 7 days.

Condition or disease Intervention/treatment Phase
Dental Sensitivity Gingival Condition Device: DIammine SIlver fluoride Device: DIstilled water Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 144 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of DIammine SIlver Fluoride Placed Over Cervical Lesions of Permanent Teeth to Reduce Tooth Sensitivity
Study Start Date : February 2010
Estimated Primary Completion Date : March 2010
Estimated Study Completion Date : April 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Diammine Silver Fluoride
Application fo diammine silver fluoride in cervical lesions
Device: DIammine SIlver fluoride
Application of Diammine SIlver Fluoride in cervical lesions

Placebo Comparator: Distilled water
Application of distilled water in cervical lesions
Device: DIstilled water
Application of distilled water in cervical lesions

Primary Outcome Measures :
  1. Erythema [ Time Frame: 1 week ]
  2. Sensitivity [ Time Frame: 1 week ]
  3. Gingival index [ Time Frame: 1 week ]

Secondary Outcome Measures :
  1. white changes [ Time Frame: 1 week ]
  2. ulceration [ Time Frame: 1 week ]
  3. staining [ Time Frame: 1 week ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • To be included the subject must have at least one vital maxillary or mandibular cuspid or premolar with a cervical defect on the buccal surface and clinical hypersensitivity in response to air with a score not less than 15 on the VAS for pain (described below).
  • The individual will have generally healthy gum tissue surrounding this tooth and no ulceration, and no leukoplakia (white changes) in this gingival tissue.

Exclusion Criteria:

  • Excluded will be subjects who are using any type of commercially available tooth desensitizer, have received a fluoride varnish treatment within the last month, or who are taking prescription medications of any kind, are taking aspirin or nonsteroidal anti-inflammatory drugs habitually, and women who are pregnant.
  • Individuals using smokeless tobacco will be excluded. Individuals with known sensitivity to silver or other heavy-metal ions will be excluded.

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 identifier (NCT number): NCT01063530

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Universidad Andina del CUsco
Cusco, Peru
Contact: Tatiana Aparicio, DDS    5198443567   
Universidad Peruana Cayetano Heredia
Lima, Peru
Contact: Jorge L Castillo, DDS MS    511-4378084   
Sponsors and Collaborators
Universidad Peruana Cayetano Heredia
University of Washington
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Principal Investigator: Peter Milgrom, DDS University of Washington
Principal Investigator: Jorge L Castillo, DDS MS Universidad Peruana Cayetano Heredia
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Responsible Party: Jorge L Castillo, Universidad Peruana Cayetano Heredia Identifier: NCT01063530    
Other Study ID Numbers: 0000054110
First Posted: February 5, 2010    Key Record Dates
Last Update Posted: February 5, 2010
Last Verified: February 2010
Keywords provided by Universidad Peruana Cayetano Heredia:
Dental Sensitivity
Cervical lesions
Additional relevant MeSH terms:
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Dentin Sensitivity
Immune System Diseases
Tooth Diseases
Stomatognathic Diseases
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs