Trial Outcomes & Findings for Treatment of Interproximal Cavities on Primary Molar Teeth With Silver Diamine Fluoride (NCT NCT03770286)

Last Updated: 2024-10-15

Results Overview

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

Recruitment status

COMPLETED

Study phase

Target enrollment

51 participants

Primary outcome timeframe

Baseline to 6 months

Results posted on

2024-10-15

Participant Flow

Patients were offered enrollment upon radiographic ID of qualifying lesions and meeting inclusion criteria.

Unit of analysis: Number of teeth with lesions

Participant milestones

Participant milestones
Measure	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	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.	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
Overall Study STARTED	17 60	17 74	17 81
Overall Study COMPLETED	10 24	13 33	12 30
Overall Study NOT COMPLETED	7 36	4 41	5 51

Reasons for withdrawal

Reasons for withdrawal
Measure	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	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.	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
Overall Study Lost to Follow-up	6	4	3
Overall Study Protocol Violation	1	0	2

Baseline Characteristics

Gender was not collected

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Fluoride Varnish Alone n=24 Teeth 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	SDF With Super Floss n=33 Teeth 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.	SDF Without Super Floss n=30 Teeth 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	Total n=87 Teeth Total of all reporting groups
Age, Categorical <=18 years	10 Participants n=10 Participants	13 Participants n=13 Participants	12 Participants n=12 Participants	35 Participants n=35 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=10 Participants	0 Participants n=13 Participants	0 Participants n=12 Participants	0 Participants n=35 Participants
Age, Categorical >=65 years	0 Participants n=10 Participants	0 Participants n=13 Participants	0 Participants n=12 Participants	0 Participants n=35 Participants
Age, Continuous	6.5 Years STANDARD_DEVIATION 1.8 • n=10 Participants	6.8 Years STANDARD_DEVIATION 1.7 • n=13 Participants	6.2 Years STANDARD_DEVIATION 2.0 • n=12 Participants	6.5 Years STANDARD_DEVIATION 1.8 • n=35 Participants
Sex: Female, Male Female	—	—	—	0 Participants Gender was not collected
Sex: Female, Male Male	—	—	—	0 Participants Gender was not collected
Race (NIH/OMB) American Indian or Alaska Native	—	—	—	0 Participants Race/ ethnicity was not collected
Race (NIH/OMB) Asian	—	—	—	0 Participants Race/ ethnicity was not collected
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	—	—	—	0 Participants Race/ ethnicity was not collected
Race (NIH/OMB) Black or African American	—	—	—	0 Participants Race/ ethnicity was not collected
Race (NIH/OMB) White	—	—	—	0 Participants Race/ ethnicity was not collected
Race (NIH/OMB) More than one race	—	—	—	0 Participants Race/ ethnicity was not collected
Race (NIH/OMB) Unknown or Not Reported	—	—	—	0 Participants Race/ ethnicity was not collected

PRIMARY outcome

Timeframe: Baseline to 6 months

Population: Total number of teeth

Outcome measures

Outcome measures
Measure	Fluoride Varnish Alone n=10 Participants 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	SDF With Super Floss n=43 Teeth 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.	SDF Without Super Floss n=44 Teeth 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
Interproximal Caries Zone of Radiolucency Category 1 = Progression	9 Number of teeth	7 Number of teeth	10 Number of teeth
Interproximal Caries Zone of Radiolucency Category 2 = Stabilization	12 Number of teeth	31 Number of teeth	22 Number of teeth
Interproximal Caries Zone of Radiolucency Category 3 = Remineralization	10 Number of teeth	6 Number of teeth	11 Number of teeth

PRIMARY outcome

Timeframe: 6 months to 12 months

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

Outcome measures

Outcome measures
Measure	Fluoride Varnish Alone n=12 Teeth 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	SDF With Super Floss n=19 Teeth 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.	SDF Without Super Floss n=21 Teeth 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
Interproximal Caries Zone of Radiolucency Category 3 = Remineralization	3 Number of teeth	3 Number of teeth	2 Number of teeth
Interproximal Caries Zone of Radiolucency Category 1 = Progression	6 Number of teeth	3 Number of teeth	9 Number of teeth
Interproximal Caries Zone of Radiolucency Category 2 = Stabilization	3 Number of teeth	13 Number of teeth	10 Number of teeth

PRIMARY outcome

Timeframe: Baseline to 12 months

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

Outcome measures

Outcome measures
Measure	Fluoride Varnish Alone n=24 Teeth 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	SDF With Super Floss n=33 Teeth 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.	SDF Without Super Floss n=30 Teeth 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
Interproximal Caries Zone of Radiolucency Category 1 = Progression	8 Number of teeth	8 Number of teeth	10 Number of teeth
Interproximal Caries Zone of Radiolucency Category 2 = Stabilization	10 Number of teeth	20 Number of teeth	13 Number of teeth
Interproximal Caries Zone of Radiolucency Category 3 = Remineralization	6 Number of teeth	5 Number of teeth	7 Number of teeth

Adverse Events

Fluoride Varnish Alone

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

SDF With Superfloss

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

SDF Without Superfloss

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

Alexander Alcaraz

Children's Hospital Los Angeles

Phone: 323-361-2130

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place