Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

Effects of DIammine SIlver Fluoride on Tooth Sensitivity

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2010 by Universidad Peruana Cayetano Heredia.
Recruitment status was:  Not yet recruiting
University of Washington
Information provided by:
Universidad Peruana Cayetano Heredia Identifier:
First received: February 4, 2010
Last updated: NA
Last verified: February 2010
History: No changes posted

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 Intervention
Dental Sensitivity
Gingival Condition
Device: DIammine SIlver fluoride
Device: DIstilled water

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (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

Resource links provided by NLM:

Further study details as provided by Universidad Peruana Cayetano Heredia:

Primary Outcome Measures:
  • Erythema [ Time Frame: 1 week ]
  • Sensitivity [ Time Frame: 1 week ]
  • Gingival index [ Time Frame: 1 week ]

Secondary Outcome Measures:
  • white changes [ Time Frame: 1 week ]
  • ulceration [ Time Frame: 1 week ]
  • staining [ Time Frame: 1 week ]

Estimated Enrollment: 144
Study Start Date: February 2010
Estimated Study Completion Date: April 2010
Estimated Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description


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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01063530

Universidad Andina del CUsco Not yet recruiting
Cusco, Peru
Contact: Tatiana Aparicio, DDS    5198443567   
Universidad Peruana Cayetano Heredia Not yet recruiting
Lima, Peru
Contact: Jorge L Castillo, DDS MS    511-4378084   
Sponsors and Collaborators
Universidad Peruana Cayetano Heredia
University of Washington
Principal Investigator: Peter Milgrom, DDS University of Washington
Principal Investigator: Jorge L Castillo, DDS MS Universidad Peruana Cayetano Heredia
  More Information

Responsible Party: Jorge L Castillo, Universidad Peruana Cayetano Heredia Identifier: NCT01063530     History of Changes
Other Study ID Numbers: 0000054110
Study First Received: February 4, 2010
Last Updated: February 4, 2010

Keywords provided by Universidad Peruana Cayetano Heredia:
Dental Sensitivity
Cervical lesions

Additional relevant MeSH terms:
Dentin Sensitivity
Immune System Diseases
Tooth Diseases
Stomatognathic Diseases
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs processed this record on April 26, 2017