NCT02601833

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
98

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jan 2016

Longer than P75 for phase_3

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 2, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 10, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2016

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 18, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 18, 2020

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

November 22, 2021

Completed
Last Updated

November 22, 2021

Status Verified

October 1, 2021

Enrollment Period

4.7 years

First QC Date

November 2, 2015

Results QC Date

August 31, 2021

Last Update Submit

October 22, 2021

Conditions

Caries

Keywords

CariesCavity

Outcome Measures

Primary Outcomes (5)

  • 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

  • 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

  • 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

  • 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

  • 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 Outcomes (9)

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

    Baseline

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

    Baseline

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

    Baseline

  • Parent Assessment of Appearance of Child's Teeth

    12 Months

  • Parent Assessment of Treatment Provided

    12 Months

  • +4 more secondary outcomes

Study Arms (2)

Silver Diamine Fluoride

EXPERIMENTAL

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

Conventional Caries Management

ACTIVE COMPARATOR

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

Interventions

Silver Diamine FluorideDEVICE

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.

Also known as: Silver Dental Arrest
Silver Diamine Fluoride
Conventional Caries ManagementPROCEDURE

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.

Also known as: Filling, Restoration
Conventional Caries Management

Eligibility Criteria

Age2 Years - 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Michigan School of Dentistry

Ann Arbor, Michigan, 48109, United States

Location

Mott Children's Health Center

Flint, Michigan, 48503, United States

Location

Related Publications (1)

  • Cleary J, Al-Hadidi R, Scully A, Yahn W, Zaid Z, Boynton JR, Eckert GJ, Yanca E, Fontana M. A 12-Month Randomized Clinical Trial of 38% SDF vs. Restorative Treatment. JDR Clin Trans Res. 2022 Apr;7(2):135-144. doi: 10.1177/23800844211072741. Epub 2022 Feb 4.

    PMID: 35120408DERIVED

Results Point of Contact

Title
Emily Yanca Project and Data Manager
Organization
University of Michigan School of Dentistry
emthorpe@umich.edu
734-763-3988

Study Officials

  • Margherita R Fontana, DDS, PhD

    University of Michigan

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 2, 2015

First Posted

November 10, 2015

Study Start

January 1, 2016

Primary Completion

September 18, 2020

Study Completion

September 18, 2020

Last Updated

November 22, 2021

Results First Posted

November 22, 2021

Record last verified: 2021-10

Locations

US(2)