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Effectiveness of Silver Diamine Fluoride as a Treatment for Caries in Comparison to Traditional Restorative Techniques

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ClinicalTrials.gov Identifier: NCT02601833
Recruitment Status : Recruiting
First Posted : November 10, 2015
Last Update Posted : April 11, 2019
Sponsor:
Collaborator:
Mott Children's Health Center
Information provided by (Responsible Party):
Margherita Fontana, DDS, PhD, University of Michigan

Brief Summary:
The purpose of this study is to compare standard fillings and silver diamine fluoride (SDF) for treatment of cavities in baby teeth. The investigators will compare the effectiveness of stopping the cavity, cost of the treatments and the opinions of the families and the dental providers.

Condition or disease Intervention/treatment Phase
Caries Device: Silver Diamine Fluoride Procedure: Conventional Caries Management Phase 3

Detailed Description:
To determine the effectiveness of the application of silver diamine fluoride (SDF) in comparison to conventional restorative treatments in International Caries Detection and Assessment System criteria (ICDAS) 5 and 6, one and two surface carious lesions in primary molars which will be assessed based on major and minor failure criteria when followed for one year. Additionally, parents'/children's and providers' perceptions will be assessed as well as the cost of both regimens, to include both chair time spent and materials' costs.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 98 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effectiveness of Silver Diamine Fluoride as a Treatment for Caries in Comparison to Traditional Restorative Techniques: A 12 Month Randomized Controlled Trial
Study Start Date : January 2016
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Silver Diamine Fluoride
This arm will receive Silver Diamine Fluoride applied to their carious lesion, in lieu of restoration placement, with the goal of arresting caries.
Device: Silver Diamine Fluoride
No caries removal will take place. The tooth will be dried and Silver Diamine Fluoride will be placed on the carious dentin until saturated. Excess will be blotted dry with a cotton pellet.
Other Name: Silver Dental Arrest

Active Comparator: Conventional Caries Management
Restorative dental care according to American Academy of Pediatric Dentistry guidelines. This treatment typically includes administration of local anesthesia, placement of rubber dam, caries removal with rotary and hand instruments, and placement of a final restoration.
Procedure: Conventional Caries Management
These children will receive restorative dental care in alignment with the American Academy of Pediatric Dentistry guidelines, within the confines of the Mott Children's Health Center clinic. This treatment typically includes administration of local anesthesia, placement of rubber dam, caries removal with rotary and hand instruments, and placement of a final restoration.
Other Names:
  • Filling
  • Restoration




Primary Outcome Measures :
  1. Caries arrest of teeth in the SDF group measured by change in size (mm) [ Time Frame: One year ]
  2. Caries arrest of teeth in the SDF group measured by dentin color (yellow, brown, black) [ Time Frame: One year ]
  3. Caries arrest of teeth in the SDF group measured by dentin texture (soft, hard) [ Time Frame: One year ]
  4. Restoration integrity for teeth in control group (secondary caries, lost restoration, restoration needing repair) [ Time Frame: One year ]
  5. Signs of pulpal pathology (lesion reaching the pulp requiring pulpar treatment-pulpotomy and/or pulpectomy-, reversible pulpitis, irreversible pulpitis, abscess) [ Time Frame: One year ]

Secondary Outcome Measures :
  1. Number of providers who find treatment with SDF more favorable in time for treatment (more, same, less) [ Time Frame: One year ]
  2. Number of providers who find treatment with SDF more favorable in ease of treatment (easier, harder, same difficulty) [ Time Frame: One year ]
  3. Number of providers who find treatment with SDF more favorable in preference of treatment modality (more preferable, no preference, less preferable) [ Time Frame: One year ]
  4. Parent assessment of appearance of child's teeth (are you dissatisfied with appearance of the child's teeth, would you have your child's teeth treated in the same manner again) [ Time Frame: One year ]
  5. Child assessment of appearance of teeth (very happy, not happy or sad, very sad) [ Time Frame: One year ]
  6. Child assessment of experience during dental visit (didn't hurt, hurt a little, hurt a lot) [ Time Frame: One year ]
  7. Costs of treatment (dollars) [ Time Frame: One year ]
  8. Time of treatment procedures (minutes) [ Time Frame: Baseline and 6 months ]


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Ages Eligible for Study:   2 Years to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Presence of at least one active (soft) cavitated carious lesions in the primary dentition, extending into dentin (ICDAS 5 or 6)
  • The selected tooth must have a one or two surface lesion (more than 1/3 of the crown of the tooth must be remaining) and must allow for direct application of SDF
  • Study teeth will not have any spontaneous or elicited pain due to caries, tooth mobility, or signs of pulpal infection
  • Selected primary teeth must have an anticipated exfoliation date greater than 12 months away

Exclusion Criteria:

  • Hereditary developmental defects such as Amelogenesis Imperfecta and Dentinogenesis Imperfecta
  • Severe medical conditions that do not allow the child to be managed in the clinic
  • Known allergy /sensitivity to dental materials being used, including SDF
  • Inability of the child to cooperate for treatment, recall examinations, or periapical radiographs
  • Wards of the State, for consenting reasons

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 ClinicalTrials.gov identifier (NCT number): NCT02601833


Contacts
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Contact: Emily R Yanca, BS 7347633988 emthorpe@umich.edu
Contact: Margherita R Fontana, DDS, PhD 734-647-1225 mfontan@umich.edu

Locations
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United States, Michigan
University of Michigan School of Dentistry Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Emily Yanca, BS    734-763-3988    emthorpe@umich.edu   
Principal Investigator: Margherita Fontana, DDS, PhD         
Mott Children's Health Center Recruiting
Flint, Michigan, United States, 48503
Contact: Allison Scully, DDS       scullya@umich.edu   
Principal Investigator: Allison Scully, DDS         
Sponsors and Collaborators
University of Michigan
Mott Children's Health Center
Investigators
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Principal Investigator: Margherita R Fontana, DDS, PhD University of Michigan

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Responsible Party: Margherita Fontana, DDS, PhD, Professor, University of Michigan
ClinicalTrials.gov Identifier: NCT02601833     History of Changes
Other Study ID Numbers: HUM00097829
First Posted: November 10, 2015    Key Record Dates
Last Update Posted: April 11, 2019
Last Verified: April 2019

Keywords provided by Margherita Fontana, DDS, PhD, University of Michigan:
Caries
Cavity

Additional relevant MeSH terms:
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Fluorides
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs