Effects of DIammine SIlver Fluoride on Tooth Sensitivity

NCT01063530 | Unknown DMC

• 1 other identifier: 0000054110
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 2

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.

Conditions

Dental Sensitivity; Gingival Condition

Keywords

FLuoride; Dental Sensitivity; Abfraction; Cervical lesions

Outcome Measures

Primary Outcomes (3)

• Erythema

  1 week

• Sensitivity

  1 week

• Gingival index

  1 week

Secondary Outcomes (3)

• white changes

  1 week

• ulceration

  1 week

• staining

  1 week

Study Arms (2)

Diammine Silver Fluoride

EXPERIMENTAL

Application fo diammine silver fluoride in cervical lesions

Device: DIammine SIlver fluoride

Distilled water

PLACEBO COMPARATOR

Application of distilled water in cervical lesions

Device: DIstilled water

Interventions

DIammine SIlver fluoride DEVICE

Application of Diammine SIlver Fluoride in cervical lesions

Diammine Silver Fluoride

DIstilled water DEVICE

Application of distilled water in cervical lesions

Distilled water

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad Peruana Cayetano Heredia: lead
• University of Washington: collaborator

Study Sites (2)

Universidad Andina del CUsco

Cusco, Departamento de Cusco, Peru

Location

Universidad Peruana Cayetano Heredia

Lima, Lima Province, Peru

Location

Study Officials

• Peter Milgrom, DDS

  University of Washington

  PRINCIPAL INVESTIGATOR

• Jorge L Castillo, DDS MS

  Universidad Peruana Cayetano Heredia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 4, 2010
• First Posted: February 5, 2010
• Study Start: February 1, 2010
• Primary Completion: March 1, 2010
• Study Completion: April 1, 2010
• Last Updated: February 5, 2010

Record last verified: 2010-02

Locations

PE (2)