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

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ClinicalTrials.gov Identifier: NCT03770286
Recruitment Status : Recruiting
First Posted : December 10, 2018
Last Update Posted : January 31, 2019
Sponsor:
Collaborator:
University of Southern California
Information provided by (Responsible Party):
Brian Lee, DDS, Children's Hospital Los Angeles

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.

Condition or disease Intervention/treatment Phase
Dental Caries in Children Dental Caries Class II Dental Caries Device: 5% Fluoride Varnish Device: 38% Silver diamine fluoride Device: Floss Phase 3

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: Evaluator of the x-rays will be blinded.
Primary Purpose: Treatment
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
Actual Study Start Date : January 22, 2019
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tooth Decay

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 Name: 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 Name: Voco ProFluorid Varnish

Device: 38% Silver diamine fluoride
Topical varnish
Other Names:
  • Advantage Arrest 38% Silver Diamine Fluoride
  • SDF

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 Name: Voco ProFluorid Varnish

Device: 38% Silver diamine fluoride
Topical varnish
Other Names:
  • Advantage Arrest 38% Silver Diamine Fluoride
  • SDF




Primary Outcome Measures :
  1. Interproximal caries zone of radiolucency [ Time Frame: Baseline ]

    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


  2. Interproximal caries zone of radiolucency [ Time Frame: 6 months ]

    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


  3. Interproximal caries zone of radiolucency [ Time Frame: 12 months ]

    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




Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03770286


Contacts
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Contact: Brian Lee, DDS 323-361-2130 leebp@usc.edu
Contact: Alcaraz, DDS 323-361-2130

Locations
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United States, California
Childrens Hospital Los Angeles Recruiting
Los Angeles, California, United States, 90027
Contact: Brian Lee, DDS    323-660-2450    leebp@usc.edu   
Contact: Alexander R Alcaraz, DMD    323-361-2130    aalcaraz@chla.usc.edu   
Sponsors and Collaborators
Brian Lee, DDS
University of Southern California
Investigators
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Principal Investigator: Brian Lee, DDS Children's Hospital Los Angeles

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Responsible Party: Brian Lee, DDS, Pediatric Dental Resident, Children's Hospital Los Angeles
ClinicalTrials.gov Identifier: NCT03770286     History of Changes
Other Study ID Numbers: CHLA-18-00389
First Posted: December 10, 2018    Key Record Dates
Last Update Posted: January 31, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases
Fluorides
Fluorides, Topical
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs