Phase 3
N=98
Effectiveness of Silver Diamine Fluoride as a Treatment for Caries in Comparison to Traditional Restorative Techniques
Caries
Bottom Line
View on ClinicalTrials.gov: NCT02601833 ↗Enrolled (actual)
98
Serious AEs
0.0%
Results posted
Nov 2021
Primary outcome: Primary: Caries Arrest of Teeth in the SDF Group Measured by Change in Size — 10 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Silver Diamine Fluoride (Device); Conventional Caries Management (Procedure)
- Age
- Pediatric · 2+ yrs
- Sex
- All
- Sponsor
- University of Michigan
- Primary completion
- Sep 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Caries Arrest of Teeth in the SDF Group Measured by Change in Size |
10 | — |
| PRIMARY Caries Arrest of Teeth in the SDF Group Measured by Dentin Color (Yellow, Brown, Black) |
37; 0; 2 | — |
| PRIMARY Caries Arrest of Teeth in the SDF Group Measured by Dentin Texture (Soft, Hard) |
10; 29 | — |
| PRIMARY Restoration Integrity for Teeth in Control Group (Secondary Caries, Lost Restoration, Restoration Needing Repair) |
1; 1; 40 | — |
| PRIMARY Signs of Pulpal Pathology (Lesion Reaching the Pulp Requiring Pulpular Treatment-pulpotomy and/or Pulpectomy-, Reversible Pulpitis, Irreversible Pulpitis, Abscess) |
1; 1; 2; 0; 2; 0 | — |
| SECONDARY Number of Providers Who Find Treatment With SDF More Favorable in Time for Treatment (More, Same, Less) |
0; 12; 1; 27; 55; 3 | — |
| SECONDARY Number of Providers Who Find Treatment With SDF More Favorable in Ease of Treatment (Easier, Harder, Same Difficulty) |
46; 2; 10; 31; 0; 9 | — |
| SECONDARY Number of Providers Who Find Treatment With SDF More Favorable in Preference of Treatment Modality (More Preferable, no Preference, Less Preferable) |
21; 0; 35; 41; 0; 1 | — |
| SECONDARY Parent Assessment of Appearance of Child's Teeth |
33; 26; 7; 3 | — |
| SECONDARY Parent Assessment of Treatment Provided |
7; 3; 33; 26 | — |
| SECONDARY Child Assessment of Appearance of Teeth (Very Happy, Not Happy or Sad, Very Sad) |
29; 26; 7; 3; 4; 0 | — |
| SECONDARY Child Assessment of Experience During Dental Visit (Didn't Hurt, Hurt a Little, Hurt a Lot) |
27; 25; 10; 4; 3; 0 | — |
| SECONDARY Costs of Treatment (Dollars) |
20.62; 79.68 | — |
| SECONDARY Time of Treatment Procedures (Duration of Time in Minutes) |
5; 30 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT02601833). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.