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

Treatment of Interproximal Carious Lesions on Primary Molar Teeth With SDF and Super Floss Application Versus SDF Without Super Floss Versus Fluoride Varnish Alone: a Pilot Phase 3 Randomized Controlled Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Dental Caries in Children; Dental Caries; Dental Caries Class II
• Intervention / Treatment: Device: 5% Fluoride Varnish; Device: 38% Silver diamine fluoride; Device: Floss

Detailed Description

Interproximal carious lesions are challenging to control and arrest due to difficulty reaching the contact area (in between teeth), limited salivary access, and poor flossing compliance in children and adolescents when flossing themselves. The vast majority of caries observed in children ages 5 to 10 are on interproximal surfaces.

Silver diamine fluoride (SDF) is a topical medicament touted as a very safe and noninvasive alternative and/or adjunct to topical fluoride treatment or restorative treatment to halt the progress ("arrest") of caries. SDF has been shown to remineralize ("reverse") demineralized enamel or dentin, inhibit collagenases to protect dentin collagen from destruction, and have bactericidal properties to cariogenic bacteria including streptococcus mutans. Normally, SDF is applied with a microbrush directly on an exposed carious lesion, but due to difficulty reaching interproximal carious lesions, an absorbent type of floss such as Super Floss has been proposed as a delivery method for SDF application.

The purpose of this study is to investigate whether 1) 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.

The study population includes healthy children, aged 3-12, with initial interproximal decay on deciduous molars identified by radiographs. In this study, initial decay is defined as radiographic decay within enamel or extending to the dentin-enamel junction based on International Caries Classification and Management System (ICCMS). Any eligible participant will be randomly allocated to one of three treatments: Fluoride varnish (Control) application alone versus SDF application without Super Floss (Control) versus SDF application with Super Floss (Intervention), which will be applied at the initial visit. At 3, 6, and 12 months, the participants will return for reapplication of their respective treatments. At the 6 month and 12 month mark, bitewing radiographs will be taken to determine status of the interested lesion(s). If a lesion progresses beyond the outer 1/3 of dentin, then the patient will be withdrawn and recommended routine restorative dental treatment. If a lesion arrests or reverses, then the current treatment will continue until end of study duration (12 months) and re-evaluated.

A statistician will be assisting us with descriptive statistics, cluster-adjusted chi-squared test, and other statistics to determine if any correlation exists.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Stephanie Shimizu, DDS; Phone Number: 925-787-6981; Email: sshimizu@chla.usc.edu
• Study Contact Backup: Name: Alexander Alcaraz, DDS; Phone Number: 323-361-2130

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90027
      • Recruiting
      • Childrens Hospital Los Angeles
      • Contact: Stephanie Shimizu, DDS; Phone Number: 925-787-6981; Email: sshimizu@chla.usc.edu
      • Contact: Alexander R Alcaraz, DMD; Phone Number: 323-361-2130; Email: aalcaraz@chla.usc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Fluoride Varnish alone; 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; Topical varnish; Other Names: Voco ProFluorid Varnish
Experimental: SDF with Super Floss; 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; Topical varnish; Other Names: Voco ProFluorid Varnish; Device: 38% Silver diamine fluoride; Topical varnish; Other Names: SDF; Advantage Arrest 38% Silver Diamine Fluoride; Device: Floss; Floss will be used as a delivery agent of SDF to target interproximal carious lesion.; Other Names: Oral-B Super Floss; woven floss; spongy floss
Experimental: SDF without Super Floss; 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; Topical varnish; Other Names: Voco ProFluorid Varnish; Device: 38% Silver diamine fluoride; Topical varnish; Other Names: SDF; Advantage Arrest 38% Silver Diamine Fluoride

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 = Radiolucency in the outer 1/2 of enamel Category 2 = Radiolucency in the inner 1/2 of enamel Category 3 = Radiolucency in the outer 1/3 of dentin	Baseline
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 = Radiolucency in the outer 1/2 of enamel Category 2 = Radiolucency in the inner 1/2 of enamel Category 3 = Radiolucency in the outer 1/3 of dentin	6 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 = Radiolucency in the outer 1/2 of enamel Category 2 = Radiolucency in the inner 1/2 of enamel Category 3 = Radiolucency in the outer 1/3 of dentin	12 months

Collaborators and Investigators

• Sponsor: Stephanie Shimizu
• Collaborators: University of Southern California
• Investigators: Principal Investigator: Stephanie Shimizu, DDS, CHLA, USC

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 22, 2019
• Primary Completion (Anticipated): December 1, 2022
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: December 6, 2018
• First Submitted That Met QC Criteria: December 6, 2018
• First Posted (Actual): December 10, 2018

Study Record Updates

• Last Update Posted (Actual): August 10, 2022
• Last Update Submitted That Met QC Criteria: August 6, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Demineralization; Tooth Diseases; Dental Caries; Physiological Effects of Drugs; Protective Agents; Cariostatic Agents; Fluorides; Fluorides, Topical
• Other Study ID Numbers: CHLA-18-00389

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes