Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| University of Southern California | OTHER |
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 5% Fluoride Varnish | Device | Topical varnish |
|
| 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 = 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 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Alexander Alcaraz, DDS | CHLA, USC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Childrens Hospital Los Angeles | Los Angeles | California | 90027 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26897901 | Background | 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. | |
| 19278981 | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Patients were offered enrollment upon radiographic ID of qualifying lesions and meeting inclusion criteria.
| ID | Title | Description |
|---|---|---|
| FG000 | 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. 5% Fluoride Varnish: Topical varnish |
| FG001 | 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. 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. |
| FG002 | 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. 5% Fluoride Varnish: Topical varnish 38% Silver diamine fluoride: Topical varnish |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Ethnicity and gender were not collected
| ID | Title | Description |
|---|---|---|
| BG000 | 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. 5% Fluoride Varnish: Topical varnish |
| BG001 | SDF With Super Floss |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | All participants are under the age of 18. Therefore, there are '0' in the categories of 18-65 and over 65. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 = Progression Category 2 = Stabilization Category 3 = Remineralization | Total number of teeth | Posted | Number | Number of teeth | Baseline to 6 months | Teeth | Teeth |
|
No SAEs or AEs were collected or monitored
No SAEs or AEs were collected or monitored
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Fluoride Varnish Alone | No SAEs or AEs were collected or monitored. | 0 |
Not provided
Not provided
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Alexander Alcaraz | Children's Hospital Los Angeles | 323-361-2130 | aalcaraz@chla.usc.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 31, 2022 | Jul 1, 2024 | Prot_SAP_000.pdf |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003731 | Dental Caries |
| ID | Term |
|---|---|
| D017001 | Tooth Demineralization |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
Not provided
Not provided
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.
Not provided
Not provided
Evaluator of the x-rays will be blinded.
| 38% Silver diamine fluoride | Device | Topical varnish |
|
|
| Super Floss | Device | Floss will be used as a delivery agent of SDF to target interproximal carious lesion. |
|
|
| 32543369 | 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. |
| 32271666 | 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. |
| 24475208 | 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. |
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.
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.
| BG002 | 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. 5% Fluoride Varnish: Topical varnish 38% Silver diamine fluoride: Topical varnish |
| BG003 | Total | Total of all reporting groups |
| Teeth |
|
| Count of Participants |
| Participants |
| Participants |
|
|
| Age, Continuous | Mean | Standard Deviation | Years | Participants |
|
|
| Sex: Female, Male | Data was not collected on gender | Gender was not collected | Count of Participants | Participants | No | Participants |
|
|
| Race (NIH/OMB) | Race/ ethnicity was not collected | Count of Participants | Participants | Participants |
|
|
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. 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. |
| OG002 | 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. 5% Fluoride Varnish: Topical varnish 38% Silver diamine fluoride: Topical varnish |
|
|
| 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 = Progression Category 2 = Stabilization Category 3 = Remineralization | Posted | Number | Number of teeth | 6 months to 12 months | Teeth | Teeth |
|
|
|
| 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 = Progression Category 2 = Stabilization Category 3 = Remineralization | Posted | Number | Number of teeth | Baseline to 12 months | Teeth | Teeth |
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | SDF With Superfloss | No SAEs or AEs were collected or monitored. | 0 | 0 | 0 | 0 | 0 | 0 |
| EG002 | SDF Without Superfloss | No SAEs or AEs were collected or monitored. | 0 | 0 | 0 | 0 | 0 | 0 |
Not provided
Not provided
Not provided
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
| Category 3 = Remineralization |
|
|
| Category 3 = Remineralization |
|