Treatment of Interproximal Cavities on Primary Molar Teeth With Silver Diamine Fluoride

NCT03770286 | Completed Results FDA Device

• 1 other identifier: CHLA-18-00389
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief Summary

This study investigates whether 1) Silver diamine fluoride (SDF) application using Super Floss can arrest and/or reverse initial interproximal caries on primary molars and 2) whether SDF applied with Super Floss is more effective in arresting or remineralizing initial interproximal lesion in comparison to SDF applied without Super Floss or fluoride varnish applied alone.

Conditions

Dental Caries in Children; Dental Caries Class II; Dental Caries

Outcome Measures

Primary Outcomes (3)

• Interproximal Caries Zone of Radiolucency

  Bitewing radiographs will be taken of target lesions at Day 1 (baseline). Target interproximal carious lesion(s) will be rated based on the zone of radiolucency on the radiographs using the International Caries Classification and Management System (ICCMS). Category 1 = Progression Category 2 = Stabilization Category 3 = Remineralization

  Baseline to 6 months

• Interproximal Caries Zone of Radiolucency

  Bitewing radiographs will be taken of target lesions at 6 months and compared. Target interproximal carious lesion(s) will be rated based on the zone of radiolucency on the radiographs using the International Caries Classification and Management System (ICCMS). Category 1 = Progression Category 2 = Stabilization Category 3 = Remineralization

  6 months to 12 months

• Interproximal Caries Zone of Radiolucency

  Bitewing radiographs will be taken of target lesions at 12 months and compared. Target interproximal carious lesion(s) will be rated based on the zone of radiolucency on the radiographs using the International Caries Classification and Management System (ICCMS). Category 1 = Progression Category 2 = Stabilization Category 3 = Remineralization

  Baseline to 12 months

Study Arms (3)

Fluoride Varnish alone

ACTIVE COMPARATOR

5% sodium fluoride varnish will be applied to all teeth the day of acceptance into the study and then at 3 months, 6 months, and 12 months.

Device: 5% Fluoride Varnish

SDF with Super Floss

EXPERIMENTAL

SDF will be applied to target interproximal lesions with the use of Super Floss for 1 minute. 5% sodium fluoride varnish will then be applied to all teeth. Both will occur the day of acceptance into the study and then at 3 months, 6 months, and 12 months.

Device: 5% Fluoride Varnish; Device: 38% Silver diamine fluoride; Device: Super Floss

SDF without Super Floss

EXPERIMENTAL

SDF will be applied to around the (buccal, lingual, and occlusal) embrasures of the target interproximal lesions with the use of a microbrush for 1 minute. 5% sodium fluoride varnish will then be applied to all teeth. Both will occur the day of acceptance into the study and then at 3 months, 6 months, and 12 months.

Device: 5% Fluoride Varnish; Device: 38% Silver diamine fluoride

Interventions

5% Fluoride Varnish DEVICE

Topical varnish

Also known as: Voco ProFluorid Varnish

Fluoride Varnish alone; SDF with Super Floss; SDF without Super Floss

38% Silver diamine fluoride DEVICE

Topical varnish

Also known as: Advantage Arrest 38% Silver Diamine Fluoride, SDF

SDF with Super Floss; SDF without Super Floss

Super Floss DEVICE

Floss will be used as a delivery agent of SDF to target interproximal carious lesion.

Also known as: Oral-B Super Floss, woven floss, spongy floss

SDF with Super Floss

Eligibility Criteria

• Age: 3 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• ASA I and ASA II children, aged 3-12
• Behavior of 3 or 4 on Frankl scale
• Radiographic decay within enamel or extending to the dentin-enamel junction based on International Caries Classification and Management System (ICCMS) Categories 1, 2 and 3 "Initial stages".
• Target interproximal lesion does not have existing restoration, recurrent decay, or adjacent teeth with existing restorations.

You may not qualify if:

• Children who are not ASA I or ASA II
• Children who are allergic to or intolerant of SDF
• Children who have known sensitivity to silver or heavy metal-ions, or have abnormal skin sensitization.
• Children who have ulcerative gingivitis or stomatitis.
• Carious interproximal lesions on primary molars in ICCMS Category 4, 5, or 6 18 , which signify the extent of the carious lesion radiographically reaching the middle 1/3 of dentin, inner 1/3 of dentin, and into the pulp respectively.
• Behavior of a child within the Frankl 1 or 2 category, indicating a "Definitely Negative" and "Negative" behavior, which may compromise safe application of SDF.

Sponsors & Collaborators

• Children's Hospital Los Angeles: lead
• University of Southern California: collaborator

Study Sites (1)

Childrens Hospital Los Angeles

Los Angeles, California, 90027, United States

Location

Related Publications (5)

• Horst JA, Ellenikiotis H, Milgrom PL. UCSF Protocol for Caries Arrest Using Silver Diamine Fluoride: Rationale, Indications and Consent. J Calif Dent Assoc. 2016 Jan;44(1):16-28.

  PMID: 26897901 BACKGROUND

• Rosenblatt A, Stamford TC, Niederman R. Silver diamine fluoride: a caries "silver-fluoride bullet". J Dent Res. 2009 Feb;88(2):116-25. doi: 10.1177/0022034508329406.

  PMID: 19278981 BACKGROUND

• Sihra R, Schroth RJ, Bertone M, Martin H, Patterson B, Mittermuller BA, Lee V, Patterson B, Moffatt ME, Klus B, Fontana M, Robertson L. The Effectiveness of Silver Diamine Fluoride and Fluoride Varnish in Arresting Caries in Young Children and Associated Oral Health-Related Quality of Life. J Can Dent Assoc. 2020 Jun;86:k9.

  PMID: 32543369 BACKGROUND

• Hammersmith KJ, DePalo JR, Casamassimo PS, MacLean JK, Peng J. Silver Diamine Fluoride and Fluoride Varnish May Halt Interproximal Caries Progression in the Primary Dentition. J Clin Pediatr Dent. 2020;44(2):79-83. doi: 10.17796/1053-4625-44.2.2.

  PMID: 32271666 BACKGROUND

• Schwendicke F, Meyer-Lueckel H, Stolpe M, Dorfer CE, Paris S. Costs and effectiveness of treatment alternatives for proximal caries lesions. PLoS One. 2014 Jan 27;9(1):e86992. doi: 10.1371/journal.pone.0086992. eCollection 2014.

  PMID: 24475208 BACKGROUND

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Limitations and Caveats

The study suffered from a small sample size and a considerable number of patients who missed follow-up visits. Higher than expected lack of treatment adherence can be attributed to the study being conducted amidst the challenging circumstances of the COVID-19 pandemic, which posed difficulties in ensuring consistent patient follow-ups and strict adherence to treatment timelines.

Results Point of Contact

• Title: Alexander Alcaraz
• Organization: Children's Hospital Los Angeles

aalcaraz@chla.usc.edu

323-361-2130

Study Officials

• Alexander Alcaraz, DDS

  CHLA, USC

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Evaluator of the x-rays will be blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Staff/USC Faculty CWR

Model Details: Silver diamine fluoride is a medicament that can be used to remineralize and treat demineralized tooth structure. This studies Silver Diamine Fluoride application as a treatment for interproximal caries. It also compares Super Floss and Microbrush as ways in which to apply the medicament.

Study Record Dates

• First Submitted: December 6, 2018
• First Posted: December 10, 2018
• Study Start: January 22, 2019
• Primary Completion: May 31, 2023
• Study Completion: May 31, 2023
• Last Updated: October 15, 2024
• Results First Posted: October 15, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)