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Completed

NCT Number: NCT02601833

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

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.

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Key information

Conditions

Caries

Age range

2 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University of Michigan School of Dentistry, Ann Arbor, Michigan, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Silver diamine fluoride

Device

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 names: Silver Dental Arrest

Conventional Caries Management

Procedure

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 outcomes

  1. Caries Arrest of Teeth in the SDF Group Measured by Change in Size

    Time frame: 12 Months

    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.

  2. Caries Arrest of Teeth in the SDF Group Measured by Dentin Color (Yellow, Brown, Black)

    Time frame: 12 Months

    Color of the cavity at the end of the trial

  3. Caries Arrest of Teeth in the SDF Group Measured by Dentin Texture (Soft, Hard)

    Time frame: 12 Months

    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.

  4. Restoration Integrity for Teeth in Control Group (Secondary Caries, Lost Restoration, Restoration Needing Repair)

    Time frame: 12 Months

    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.

  5. Signs of Pulpal Pathology (Lesion Reaching the Pulp Requiring Pulpular Treatment-pulpotomy and/or Pulpectomy-, Reversible Pulpitis, Irreversible Pulpitis, Abscess)

    Time frame: 12 Months

    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.

Secondary outcomes

  1. Number of Providers Who Find Treatment With SDF More Favorable in Time for Treatment (More, Same, Less)

    Time frame: Baseline

    Data collected at baseline only.

  2. Number of Providers Who Find Treatment With SDF More Favorable in Ease of Treatment (Easier, Harder, Same Difficulty)

    Time frame: Baseline

  3. Number of Providers Who Find Treatment With SDF More Favorable in Preference of Treatment Modality (More Preferable, no Preference, Less Preferable)

    Time frame: Baseline

  4. Parent Assessment of Appearance of Child's Teeth

    Time frame: 12 Months

    Parents were asked "Are you concerned with the appearance of your child's teeth?"

  5. Parent Assessment of Treatment Provided

    Time frame: 12 Months

    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?"

  6. Child Assessment of Appearance of Teeth (Very Happy, Not Happy or Sad, Very Sad)

    Time frame: 12 Months

  7. Child Assessment of Experience During Dental Visit (Didn't Hurt, Hurt a Little, Hurt a Lot)

    Time frame: 12 Months

  8. Costs of Treatment (Dollars)

    Time frame: Baseline

    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.

  9. Time of Treatment Procedures (Duration of Time in Minutes)

    Time frame: Baseline

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • Mott Children's Health Center

Registry information

Official study title

The Effectiveness of Silver Diamine Fluoride as a Treatment for Caries in Comparison to Traditional Restorative Techniques: A 12 Month Randomized Controlled Trial

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Nov 10, 2015
Registry last updated
Nov 22, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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