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.
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.
Study Type
OBSERVATIONAL
Enrollment
237
Application of dental caries arresting topical medication
UGEL Manazo
Puno, Puno, Peru
UGEL Puno 210001 Las Torres
Puno, Puno, Peru
UGEL Puno Magisterial
Puno, Puno, Peru
UGEL San Jose
Puno, Puno, Peru
UGEL Villa del Lago
Puno, Puno, Peru
Lesion Activity
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).
Time frame: 12 months
Lesion Activity
Percentage of baseline d2/d3 caries lesions arrested at 5-month follow-up. The outcome measured on each participant is the percentage of baseline d2/d3 caries lesions arrested at 5-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 5 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).
Time frame: 5 months
Caries Increment
Number of new caries (d2-4mfs) from baseline to 5-month follow-up.
Time frame: 5 months
Caries Increment
Number of new caries (d2-4mfs) from baseline to 12-month follow-up.
Time frame: 12 months
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Incidence of (New) Caries Lesions
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.
Time frame: 5 months
Incidence of (New) Caries Lesions
The incidence of (new) caries lesions (d2-4mfs) per 1 surface-year at risk is the number of new caries lesions at 12 months 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.
Time frame: 12 months
Satisfaction With Color Changes in Teeth
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.
Time frame: 12 months