Dental Caries, Dental Caries Class II, Dental Caries in Children
Conditions
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.
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.
Interventions
DEVICE5% Fluoride Varnish
Topical varnish
Topical varnish
DEVICESuper Floss
Floss will be used as a delivery agent of SDF to target interproximal carious lesion.
Sponsors
University of Southern California
Children's Hospital Los Angeles
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Evaluator of the x-rays will be blinded.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
3 Years to 12 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Interproximal Caries Zone of Radiolucency | 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 |
Countries
United States
Participant flow
Recruitment details
Patients were offered enrollment upon radiographic ID of qualifying lesions and meeting inclusion criteria.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 10 |
| 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 | 24 |
| 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. | 13 |
| 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. | 33 |
| 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 | 12 |
| 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 | 30 |
| Total | 122 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 6 | 4 | 3 |
| Overall Study | Protocol Violation | 1 | 0 | 2 |
Baseline characteristics
| Characteristic | Total | Fluoride Varnish Alone | SDF With Super Floss | SDF Without Super Floss |
|---|---|---|---|---|
| Age, Categorical <=18 years | 35 Participants | 10 Participants | 13 Participants | 12 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 6.5 Years STANDARD_DEVIATION 1.8 | 6.5 Years STANDARD_DEVIATION 1.8 | 6.8 Years STANDARD_DEVIATION 1.7 | 6.2 Years STANDARD_DEVIATION 2 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | — | — | — |
| Race (NIH/OMB) Asian | 0 Participants | — | — | — |
| Race (NIH/OMB) Black or African American | 0 Participants | — | — | — |
| Race (NIH/OMB) More than one race | 0 Participants | — | — | — |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | — | — | — |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | — | — | — |
| Race (NIH/OMB) White | 0 Participants | — | — | — |
| Sex: Female, Male Female | 0 Participants | — | — | — |
| Sex: Female, Male Male | 0 Participants | — | — | — |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 | 0 / 0 |
Outcome results
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
Time frame: Baseline to 6 months
Population: Total number of teeth
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fluoride Varnish Alone | Interproximal Caries Zone of Radiolucency | Category 2 = Stabilization | 12 Number of teeth |
| Fluoride Varnish Alone | Interproximal Caries Zone of Radiolucency | Category 1 = Progression | 9 Number of teeth |
| Fluoride Varnish Alone | Interproximal Caries Zone of Radiolucency | Category 3 = Remineralization | 10 Number of teeth |
| SDF With Super Floss | Interproximal Caries Zone of Radiolucency | Category 2 = Stabilization | 31 Number of teeth |
| SDF With Super Floss | Interproximal Caries Zone of Radiolucency | Category 1 = Progression | 7 Number of teeth |
| SDF With Super Floss | Interproximal Caries Zone of Radiolucency | Category 3 = Remineralization | 6 Number of teeth |
| SDF Without Super Floss | Interproximal Caries Zone of Radiolucency | Category 1 = Progression | 10 Number of teeth |
| SDF Without Super Floss | Interproximal Caries Zone of Radiolucency | Category 3 = Remineralization | 11 Number of teeth |
| SDF Without Super Floss | Interproximal Caries Zone of Radiolucency | Category 2 = Stabilization | 22 Number of teeth |
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
Time frame: 6 months to 12 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fluoride Varnish Alone | Interproximal Caries Zone of Radiolucency | Category 2 = Stabilization | 3 Number of teeth |
| Fluoride Varnish Alone | Interproximal Caries Zone of Radiolucency | Category 1 = Progression | 6 Number of teeth |
| Fluoride Varnish Alone | Interproximal Caries Zone of Radiolucency | Category 3 = Remineralization | 3 Number of teeth |
| SDF With Super Floss | Interproximal Caries Zone of Radiolucency | Category 2 = Stabilization | 13 Number of teeth |
| SDF With Super Floss | Interproximal Caries Zone of Radiolucency | Category 1 = Progression | 3 Number of teeth |
| SDF With Super Floss | Interproximal Caries Zone of Radiolucency | Category 3 = Remineralization | 3 Number of teeth |
| SDF Without Super Floss | Interproximal Caries Zone of Radiolucency | Category 1 = Progression | 9 Number of teeth |
| SDF Without Super Floss | Interproximal Caries Zone of Radiolucency | Category 3 = Remineralization | 2 Number of teeth |
| SDF Without Super Floss | Interproximal Caries Zone of Radiolucency | Category 2 = Stabilization | 10 Number of 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
Time frame: Baseline to 12 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fluoride Varnish Alone | Interproximal Caries Zone of Radiolucency | Category 2 = Stabilization | 10 Number of teeth |
| Fluoride Varnish Alone | Interproximal Caries Zone of Radiolucency | Category 1 = Progression | 8 Number of teeth |
| Fluoride Varnish Alone | Interproximal Caries Zone of Radiolucency | Category 3 = Remineralization | 6 Number of teeth |
| SDF With Super Floss | Interproximal Caries Zone of Radiolucency | Category 2 = Stabilization | 20 Number of teeth |
| SDF With Super Floss | Interproximal Caries Zone of Radiolucency | Category 1 = Progression | 8 Number of teeth |
| SDF With Super Floss | Interproximal Caries Zone of Radiolucency | Category 3 = Remineralization | 5 Number of teeth |
| SDF Without Super Floss | Interproximal Caries Zone of Radiolucency | Category 1 = Progression | 10 Number of teeth |
| SDF Without Super Floss | Interproximal Caries Zone of Radiolucency | Category 3 = Remineralization | 7 Number of teeth |
| SDF Without Super Floss | Interproximal Caries Zone of Radiolucency | Category 2 = Stabilization | 13 Number of teeth |