Dental Caries in Children
Conditions
Keywords
Silver Diamine Fluoride, Sodium Fluoride Varnish, Dental Caries, Primary Dentition, Peru
Brief summary
A single group observational study to determine the clinical response of dental caries lesions in primary teeth where 38% silver diamine fluoride gel is applied and cover with 2.5% sodium fluoride varnish. Additionally, to assess parent satisfaction with treatment with 38% silver diamine fluoride.
Detailed description
A single group observational study of 235 children ages 3 and 4 with severe early childhood caries where the lesions are treated with 38% silver diamine fluoride and covered with 2.5% sodium fluoride varnish at baseline and 6 months. The primary objective is to determine the response of dental caries lesions (caries arrest) into the dentin in primary teeth at one year of follow-up. The secondary objective is to assess parent satisfaction with treatment with 38% silver diamine fluoride and 2.5% sodium fluoride varnish.
Interventions
DEVICESilver Diamine Fluoride/Sodium Fluoride Varnish
Application of dental caries arresting topical medication
Sponsors
Advantage Silver Dental Arrest, LLC
Universidad Nacional Del Altiplano Puno
University of Washington
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
3 Years to 4 Years
Inclusion criteria
* At least one active caries lesion Good general health by parent report
Exclusion criteria
* Unable to cooperate with exam or procedure
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Lesion Activity | 12 months | Percentage of baseline d2/d3 caries lesions arrested at 12-month follow-up. The outcome measured on each participant is the percentage of baseline d2/d3 caries lesions arrested at 12-month follow-up. It is not a binary outcome measured at the participant level. To summarize the outcome the median value based on participants with 12 month follow-up is reported, along with the interquartile range (25th and 75th percentile) and 95% confidence interval. For surfaces scored from d1 through d4, the lesion was classi ed as active or inactive using an adaptation of criteria developed by Nyvad and colleagues (Nyvad B, Machiulskiene V, Baelum V. Reliability of a new caries diagnostic system differentiating between active and inactive caries lesions. Caries Res. 1999;33(4):252-260). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Caries Increment | 5 months | Number of new caries (d2-4mfs) from baseline to 5-month follow-up. |
| Incidence of (New) Caries Lesions | 5 months | The incidence of (new) caries lesions (d2-4mfs) per 1 surface-year at risk is the number of new caries lesions at 5 month divided by the surface time at risk between baseline and 5 months. The incidence is calculated for each participant and then summarized by the median, interquartile range (25th and 75th percentiles) and 95% confidence interval. The incidence rate is expressed as the number of new caries lesions per 1 surface-year at risk. |
| Satisfaction With Color Changes in Teeth | 12 months | Bothered by color changes in the teeth (1-10 scale), where 1 = not at all bothered and 10 = very bothered. Higher scores mean more bothered. |
Countries
Peru
Contacts
PRINCIPAL_INVESTIGATORTaina Padilla Caceres, DDS
Universidad Nacional del Altiplano
Baseline characteristics
| Characteristic | — |
|---|---|
| Active surfaces of decay | 22 Tooth surface |
| Age, Categorical <=18 years | 237 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Race/Ethnicity, Customized Hispanic American/South American Native | 237 Participants |
| Region of Enrollment Peru | 237 participants |
| Sex/Gender, Customized Female | 119 Participants |
| Sex/Gender, Customized Male | 108 Participants |
| Sex/Gender, Customized Unknown | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 237 |
| other Total, other adverse events | 0 / 237 |
| serious Total, serious adverse events | 0 / 237 |
Outcome results
None listed