Trial Outcomes & Findings for Silver Diamine Fluoride Gel: Single Group Observational Study (NCT NCT05395065)

Results Overview

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).

Recruitment status

COMPLETED

Target enrollment

237 participants

Primary outcome timeframe

12 months

Results posted on

2026-08-17

Participant Flow

Unit of analysis: Tooth surfaces

Participant milestones

Participant milestones
Measure	SDF/FV Topical Application of 38% silver diamine fluoride and 2.5% sodium fluoride varnish at baseline and 6 months Silver Diamine Fluoride/Sodium Fluoride Varnish: Application of dental caries arresting topical medication There is only one group. All participants received the same silver diamine fluoride/sodium fluoride varnish.
Overall Study STARTED	237 20856
Overall Study COMPLETED	219 19272
Overall Study NOT COMPLETED	18 1584

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

18 children lost to follow-up mainly because child changed schools.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	SDF/FV n=20856 Tooth surfaces Topical Application of 38% silver diamine fluoride and 2.5% sodium fluoride varnish at baseline and 6 months Silver Diamine Fluoride/Sodium Fluoride Varnish: Application of dental caries arresting topical medication
Age, Categorical <=18 years	237 Participants n=51 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=51 Participants
Age, Categorical >=65 years	0 Participants n=51 Participants
Sex/Gender, Customized Female	119 Participants n=51 Participants
Sex/Gender, Customized Male	108 Participants n=51 Participants
Sex/Gender, Customized Unknown	10 Participants n=51 Participants
Race/Ethnicity, Customized Hispanic American/South American Native	237 Participants n=51 Participants
Region of Enrollment Peru	237 participants n=51 Participants
Active surfaces of decay	22 Tooth surface n=20856 Tooth surfaces • 18 children lost to follow-up mainly because child changed schools.

PRIMARY outcome

Timeframe: 12 months

Population: 219 of 237 of enrolled children available at 12-month follow-up.

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).

Outcome measures

Outcome measures
Measure	SDF/FV n=19272 Tooth surfaces Topical Application of 38% silver diamine fluoride and 2.5% sodium fluoride varnish at baseline and 6 months Silver Diamine Fluoride/Sodium Fluoride Varnish: Application of dental caries arresting topical medication
Lesion Activity	92.6 Percentage of arrested d2/d3 lesions Interval 81.1 to 100.0

PRIMARY outcome

Timeframe: 5 months

Population: 212 of 237 enrolled children were available at 5-month follow-up.

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).

Outcome measures

Outcome measures
Measure	SDF/FV n=18656 Tooth surfaces Topical Application of 38% silver diamine fluoride and 2.5% sodium fluoride varnish at baseline and 6 months Silver Diamine Fluoride/Sodium Fluoride Varnish: Application of dental caries arresting topical medication
Lesion Activity	82.1 Percentage of arrested d2/d3 lesions Interval 66.4 to 94.6

SECONDARY outcome

Timeframe: 5 months

Population: 212 of 237 enrolled children were available at 5-month follow-up.

Number of new caries (d2-4mfs) from baseline to 5-month follow-up.

Outcome measures

Outcome measures
Measure	SDF/FV n=18656 Tooth surfaces Topical Application of 38% silver diamine fluoride and 2.5% sodium fluoride varnish at baseline and 6 months Silver Diamine Fluoride/Sodium Fluoride Varnish: Application of dental caries arresting topical medication
Caries Increment	2 Number of new caries Interval 1.0 to 5.0

SECONDARY outcome

Timeframe: 12 months

Population: 219 of 237 enrolled children were available at 12-month follow-up.

Number of new caries (d2-4mfs) from baseline to 12-month follow-up.

Outcome measures

Outcome measures
Measure	SDF/FV n=19272 Tooth surfaces Topical Application of 38% silver diamine fluoride and 2.5% sodium fluoride varnish at baseline and 6 months Silver Diamine Fluoride/Sodium Fluoride Varnish: Application of dental caries arresting topical medication
Caries Increment	4 Number of new caries Interval 2.0 to 8.0

SECONDARY outcome

Timeframe: 5 months

Population: 212 of 237 enrolled children were available at 5-month follow-up.

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.

Outcome measures

Outcome measures
Measure	SDF/FV n=18656 Tooth surfaces Topical Application of 38% silver diamine fluoride and 2.5% sodium fluoride varnish at baseline and 6 months Silver Diamine Fluoride/Sodium Fluoride Varnish: Application of dental caries arresting topical medication
Incidence of (New) Caries Lesions	0.10 Caries per 1 surface-year at risk Interval 0.03 to 0.22

SECONDARY outcome

Timeframe: 12 months

Population: 219 of 237 enrolled children were available at 12-month follow-up.

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.

Outcome measures

Outcome measures
Measure	SDF/FV n=19272 Tooth surfaces Topical Application of 38% silver diamine fluoride and 2.5% sodium fluoride varnish at baseline and 6 months Silver Diamine Fluoride/Sodium Fluoride Varnish: Application of dental caries arresting topical medication
Incidence of (New) Caries Lesions	0.08 Caries per 1 surface-year at risk Interval 0.04 to 0.14

SECONDARY outcome

Timeframe: 12 months

Population: 215 parent questionnaires were available at the 12-month follow-up.

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.

Outcome measures

Outcome measures
Measure	SDF/FV n=215 Participants Topical Application of 38% silver diamine fluoride and 2.5% sodium fluoride varnish at baseline and 6 months Silver Diamine Fluoride/Sodium Fluoride Varnish: Application of dental caries arresting topical medication
Satisfaction With Color Changes in Teeth	1 Units on a 1 to 10 scale Interval 1.0 to 2.0

Adverse Events

SDF/FV

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Peter Milgrom

Advantage Silver Dental Arrest, LLC

Phone: (206) 251-6831

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place