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
Recruitment status was Not yet recruiting
Sponsor:
Universidad Peruana Cayetano Heredia
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
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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
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 May 19, 2013