Effects of DIammine SIlver Fluoride on Tooth Sensitivity

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2010 by Universidad Peruana Cayetano Heredia.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
University of Washington
Information provided by:
Universidad Peruana Cayetano Heredia
ClinicalTrials.gov Identifier:
NCT01063530
First received: February 4, 2010
Last updated: NA
Last verified: February 2010
History: No changes posted
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: Yes ]
  • Sensitivity [ Time Frame: 1 week ] [ Designated as safety issue: No ]
  • Gingival index [ Time Frame: 1 week ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • white changes [ Time Frame: 1 week ] [ Designated as safety issue: Yes ]
  • ulceration [ Time Frame: 1 week ] [ Designated as safety issue: Yes ]
  • staining [ Time Frame: 1 week ] [ Designated as safety issue: Yes ]

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

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 ClinicalTrials.gov identifier: NCT01063530

Locations
Peru
Universidad Andina del CUsco Not yet recruiting
Cusco, Peru
Contact: Tatiana Aparicio, DDS    5198443567    tatianaaparicio@hotmail.com   
Universidad Peruana Cayetano Heredia Not yet recruiting
Lima, Peru
Contact: Jorge L Castillo, DDS MS    511-4378084    jcastillo_1@terra.com.pe   
Sponsors and Collaborators
Universidad Peruana Cayetano Heredia
University of Washington
Investigators
Principal Investigator: Peter Milgrom, DDS University of Washington
Principal Investigator: Jorge L Castillo, DDS MS Universidad Peruana Cayetano Heredia
  More Information

No publications provided

Responsible Party: Jorge L Castillo, Universidad Peruana Cayetano Heredia
ClinicalTrials.gov Identifier: NCT01063530     History of Changes
Other Study ID Numbers: 0000054110
Study First Received: February 4, 2010
Last Updated: February 4, 2010
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Dentin Sensitivity
Tooth Diseases
Stomatognathic Diseases
Fluorides
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014