Dental Caries in ChildrenNCT03770286

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

A study testing 5% Fluoride Varnish, 38% Silver diamine fluoride and Super Floss in people with Dental Caries in Children and Dental Caries Class II, run by Children's Hospital Los Angeles at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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… Read more about this study

Who is it for?: Ages 3 to 12 yearsHealthy volunteers can take part
Conditions the study is for: Dental Caries in Children, Dental Caries Class II, Dental Caries
What is being tested?: 5% Fluoride Varnish, 38% Silver diamine fluoride and Super Floss
Type of treatment: Pill or oral medicine, Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 51 participants
Where: 1 siteUnited States
Study dates: 22 Jan 2019to 31 May 2023
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 3 to 12 years
All sexes
Healthy volunteers accepted
Child

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

Childrens Hospital Los Angeles
Los Angeles, California, 90027

Other trials in United States

About this study

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

Read the 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.

Conditions: Dental Caries in Children, Dental Caries Class II, Dental Caries
Being tested: 5% Fluoride Varnish, 38% Silver diamine fluoride, Super Floss
Medical subject headings: Dental Caries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

5% Fluoride VarnishDevice
Also called Voco ProFluorid Varnish
Topical varnish
38% Silver diamine fluorideDevice
Also called Advantage Arrest 38% Silver Diamine Fluoride, SDF
Topical varnish
Super FlossDevice
Also called Oral-B Super Floss, woven floss, spongy floss
Floss will be used as a delivery agent of SDF to target interproximal carious lesion.

Study groups in NCT03770286
Study group	Role	What they receive
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. Receives: 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. Receives: 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. Receives: Device: 5% Fluoride Varnish; Device: 38% Silver diamine fluoride

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 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
Measured: 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
Measured: Baseline to 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

22 Jan 201931 May 2023

First posted10 Dec 2018
Study start22 Jan 2019
Primary completion31 May 2023
Study completion31 May 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (5)Papers the sponsor has linked to this study.
Other trials for Dental Caries in ChildrenStudies of the same condition, open and under way.
More trials run by Children's Hospital Los AngelesThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: 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.
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 51 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03770286
Sponsor's protocol ID: CHLA-18-00389
Status last verified: Sep 2024
First submitted: 6 Dec 2018
Last updated: 15 Oct 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

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.
PubMed 26897901
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.
PubMed 19278981
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.
PubMed 32543369
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.
PubMed 32271666
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.
PubMed 24475208

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Dental Caries in Children trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT03770286
Acronym / sponsor ID: CHLA-18-00389
Conditions: Dental Caries in Children, Dental Caries Class II, Dental Caries
Study type: Interventional
Recruitment status: Completed
Enrolment: 51 participants (actual)
Lead sponsor: Children's Hospital Los AngelesUniversity, hospital or other
Collaborators: University of Southern California
Study start: 22 Jan 2019 (actual)
Primary completion: 31 May 2023 (actual)
Study completion: 31 May 2023 (actual)
First posted: 10 Dec 2018 (actual)
Results: Posted 15 Oct 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 3
Model description: 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.

Arm	Type	Receives
Fluoride Varnish alone	Active comparator	Device: 5% Fluoride Varnish5% 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.
SDF with Super Floss	Experimental	Device: 5% Fluoride Varnish, Device: 38% Silver diamine fluoride, Device: Super FlossSDF 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.
SDF without Super Floss	Experimental	Device: 5% Fluoride Varnish, Device: 38% Silver diamine fluorideSDF 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.

Who may qualify

Ages: 3 to 12 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (6 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
5% Fluoride VarnishAlso: Voco ProFluorid VarnishTopical varnish	Device	Fluoride Varnish alone, SDF with Super Floss, SDF without Super Floss
38% Silver diamine fluorideAlso: Advantage Arrest 38% Silver Diamine Fluoride, SDFTopical varnish	Device	SDF with Super Floss, SDF without Super Floss
Super FlossAlso: Oral-B Super Floss, woven floss, spongy flossFloss will be used as a delivery agent of SDF to target interproximal carious lesion.	Device	SDF with Super Floss

Primary outcome

Interproximal Caries Zone of Radiolucency
Time frame: Baseline to 6 months
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
Interproximal Caries Zone of Radiolucency
Time frame: 6 months to 12 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 = Progression Category 2 = Stabilization Category 3 = Remineralization
Interproximal Caries Zone of Radiolucency
Time frame: Baseline to 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 = Progression Category 2 = Stabilization Category 3 = Remineralization

Results and safety

Results posted to the registry on 15 Oct 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Fluoride Varnish Alone	17	10
SDF With Super Floss	17	13
SDF Without Super Floss	17	12

Primary outcome: Interproximal Caries Zone of Radiolucency

Time frame: Baseline to 6 months. Number. Unit: Number of teeth

Measure	Fluoride Varnish Alone n = 10	SDF With Super Floss n = 13	SDF Without Super Floss n = 12
Category 1 = Progression	9	7	10
Category 2 = Stabilization	12	31	22
Category 3 = Remineralization	10	6	11

Population analysed: Total number of teeth

Primary outcome: Interproximal Caries Zone of Radiolucency

Time frame: 6 months to 12 months. Number. Unit: Number of teeth

Measure	Fluoride Varnish Alone n = 10	SDF With Super Floss n = 13	SDF Without Super Floss n = 12
Category 1 = Progression	6	3	9
Category 2 = Stabilization	3	13	10
Category 3 = Remineralization	3	3	2

Primary outcome: Interproximal Caries Zone of Radiolucency

Time frame: Baseline to 12 months. Number. Unit: Number of teeth

Measure	Fluoride Varnish Alone n = 10	SDF With Super Floss n = 13	SDF Without Super Floss n = 12
Category 1 = Progression	8	8	10
Category 2 = Stabilization	10	20	13
Category 3 = Remineralization	6	5	7

Adverse events

Time frame: No SAEs or AEs were collected or monitored. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events
Fluoride Varnish Alone	0 of 0	0 of 0
SDF With Superfloss	0 of 0	0 of 0
SDF Without Superfloss	0 of 0	0 of 0

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 26897901Horst 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.
Background: PubMed 19278981Rosenblatt 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.
Background: PubMed 32543369Sihra 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.
Background: PubMed 32271666Hammersmith 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.
Background: PubMed 24475208Schwendicke 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Alexander Alcaraz, DDS principal investigator

CHLA, USC

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Interproximal Caries Zone of Radiolucency (time frame: Baseline to 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03770286, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2024.