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

Caries Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02601833
• Other study ID #: HUM00097829
• Status: Completed
• Phase: Phase 3
• Start date: January 2016
• Est. completion date: September 18, 2020

Study information

• Verified date: October 2021
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 98
• Est. completion date: September 18, 2020
• Est. primary completion date: September 18, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 10 Years

Eligibility

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

Related Conditions & MeSH terms

• Caries

Intervention

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.

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.

Locations

Country	Name	City	State
United States	University of Michigan School of Dentistry	Ann Arbor	Michigan
United States	Mott Children's Health Center	Flint	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	Mott Children's Health Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Caries Arrest of Teeth in the SDF Group Measured by Change in Size	Number of participants in the SDF arm that had an increase in lesion size at any point in the 12 months of the trial, as this is a treatment failure.; Treatment failures were assessed throughout the 12 month duration of the trial, and children with treatment failures were then removed from the trial for further clinical treatment.	12 Months
Primary	Caries Arrest of Teeth in the SDF Group Measured by Dentin Color (Yellow, Brown, Black)	Color of the cavity at the end of the trial	12 Months
Primary	Caries Arrest of Teeth in the SDF Group Measured by Dentin Texture (Soft, Hard)	Texture of the cavity's dentin of soft means the cavity is still an active infection. If the cavity is hard, the cavity is no longer an active infection (has been arrested).; Please note dentin texture cannot be assessed for the Conventional group as the dentin is no longer accessible following baseline treatment.	12 Months
Primary	Restoration Integrity for Teeth in Control Group (Secondary Caries, Lost Restoration, Restoration Needing Repair)	Secondary caries, lost restorations, or restorations needing repair are treatment failures.; Treatment failures were assessed throughout the 12 month duration of the trial, and children with treatment failures were removed from the trial for further clinical treatment.	12 Months
Primary	Signs of Pulpal Pathology (Lesion Reaching the Pulp Requiring Pulpular Treatment-pulpotomy and/or Pulpectomy-, Reversible Pulpitis, Irreversible Pulpitis, Abscess)	Signs of pulpal pathology are treatment failures. Treatment failures were assessed throughout the 12 month duration of the trial, and children with treatment failures were removed from the trial for further clinical treatment.	12 Months
Secondary	Number of Providers Who Find Treatment With SDF More Favorable in Time for Treatment (More, Same, Less)	Data collected at baseline only.	Baseline
Secondary	Number of Providers Who Find Treatment With SDF More Favorable in Ease of Treatment (Easier, Harder, Same Difficulty)		Baseline
Secondary	Number of Providers Who Find Treatment With SDF More Favorable in Preference of Treatment Modality (More Preferable, no Preference, Less Preferable)		Baseline
Secondary	Parent Assessment of Appearance of Child's Teeth	Parents were asked "Are you concerned with the appearance of your child's teeth?"	12 Months
Secondary	Parent Assessment of Treatment Provided	Parents were asked "If your child had another cavity, would you be willing to have that tooth treated with the same treatment option provided to your child in this study?"	12 Months
Secondary	Child Assessment of Appearance of Teeth (Very Happy, Not Happy or Sad, Very Sad)		12 Months
Secondary	Child Assessment of Experience During Dental Visit (Didn't Hurt, Hurt a Little, Hurt a Lot)		12 Months
Secondary	Costs of Treatment (Dollars)	Cost of one application of SDF and one 1-2 surface conventional restoration. Cost was calculated by taking the average Medicaid reimbursement across all U.S. states.	Baseline
Secondary	Time of Treatment Procedures (Duration of Time in Minutes)		Baseline