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

Dental Caries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03770286
• Other study ID #: CHLA-18-00389
• Status: Completed
• Phase: Phase 3
• Start date: January 22, 2019
• Est. completion date: May 31, 2023

Study information

• Verified date: June 2024
• Source: Children's Hospital Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: May 31, 2023
• Est. primary completion date: May 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Years to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dental Caries
• Dental Caries Class II
• Dental Caries in Children

Intervention

Device:
• 5% Fluoride Varnish
Topical varnish
• 38% Silver diamine fluoride
Topical varnish
• Super Floss
Floss will be used as a delivery agent of SDF to target interproximal carious lesion.

Locations

Country	Name	City	State
United States	Childrens Hospital Los Angeles	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
Children's Hospital Los Angeles	University of Southern California

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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