Trial Outcomes & Findings for Efficacy Of A PVP-I Fluoride Varnish (NCT NCT03082196)

Last Updated: 2020-09-10

Results Overview

The primary outcome will be the surface-level primary molar caries increment (d2-4mfs) at two years post baseline. Caries, as measured by d2-4mfs, is the total number of surfaces with decay into the enamel (2), dentin (3) or pulp (4), missing due to caries (m), or filled with amalgam, composite or other filling material (f). This scale records whether caries is detected in any of the 5 surfaces of the tooth for up to 8 primary molar teeth that were sound at baseline, and has a range of 0 to 40. Higher values indicate a greater number of caries.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

284 participants

Primary outcome timeframe

24 months

Results posted on

2020-09-10

Participant Flow

Participant milestones

Participant milestones
Measure	Test Varnish Advantage Anti-Caries Varnish. The active ingredients are Povidone Iodine and Sodium Fluoride . Test varnish: Topical application of test varnish to the teeth 4 times per year.	Standard Varnish The active control varnish will be the same fluoride varnish without iodine with an appropriate FDA approved food dye added to match the color of the test agent. There will be no difference in the treatment and control varnishes except for the povidone iodine. Standard varnish: Topical application of test varnish to the teeth 4 times per year
Overall Study STARTED	142	142
Overall Study COMPLETED	133	129
Overall Study NOT COMPLETED	9	13

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Efficacy Of A PVP-I Fluoride Varnish

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: 24 months

Population: The analysis population is based on the 139 participants with sound molars and baseline and follow-up at 24-months.

Outcome measures

Outcome measures
Measure	Test Varnish n=72 Participants Advantage Anti-Caries Varnish. The active ingredients are Povidone Iodine and Sodium Fluoride . Test varnish: Topical application of test varnish to the teeth 4 times per year.	Standard Varnish n=67 Participants The active control varnish will be the same fluoride varnish without iodine with an appropriate FDA approved food dye added to match the color of the test agent. There will be no difference in the treatment and control varnishes except for the povidone iodine. Standard varnish: Topical application of test varnish to the teeth 4 times per year
Dental Caries for Primary Molars Sound at Baseline	2.3 units on a scale Standard Deviation 2.8	3.3 units on a scale Standard Deviation 2.7

PRIMARY outcome

Timeframe: 24 months

Population: The analysis population is based on participants with sound primary teeth at baseline and follow-up at 24 months.

The outcome will be the surface-level primary tooth caries increment (d2-4mfs) at two years post baseline that were sound at baseline. Caries, as measured by d2-4mfs, is the total number of surfaces with decay into the enamel (2), dentin (3) or pulp (4), missing due to caries (m), or filled with amalgam, composite or other filling material (f). This scale records whether caries is detected in any of the 4 or 5 surfaces of the tooth for up to 20 primary teeth that were sound at baseline, and has a range of 0 to 88. Higher values indicate a greater number of caries. The measure records whether caries is present on any of the 5 surfaces of the primary molars or 4 surfaces of the other teeth.

Outcome measures

Outcome measures
Measure	Test Varnish n=126 Participants Advantage Anti-Caries Varnish. The active ingredients are Povidone Iodine and Sodium Fluoride . Test varnish: Topical application of test varnish to the teeth 4 times per year.	Standard Varnish n=116 Participants The active control varnish will be the same fluoride varnish without iodine with an appropriate FDA approved food dye added to match the color of the test agent. There will be no difference in the treatment and control varnishes except for the povidone iodine. Standard varnish: Topical application of test varnish to the teeth 4 times per year
Dental Caries for All Primary Teeth Sound at Baseline	2.0 units on a scale Standard Deviation 2.8	2.7 units on a scale Standard Deviation 3.3

SECONDARY outcome

Timeframe: After first treatment visit

Population: The analysis population is based on participants who received the first varnish application and completed the Facial Image Scale.

Facial Images Scale which measures the child's response using a series of five happy/sad faces from a very unhappy face (5) to a very happy face (1). The minimum value is 1 which corresponds to a very happy face and the maximum value is 5 which corresponds to a very unhappy face. The possible values of the scale are 1, 2, 3, 4, or 5.

Outcome measures

Outcome measures
Measure	Test Varnish n=141 Participants Advantage Anti-Caries Varnish. The active ingredients are Povidone Iodine and Sodium Fluoride . Test varnish: Topical application of test varnish to the teeth 4 times per year.	Standard Varnish n=142 Participants The active control varnish will be the same fluoride varnish without iodine with an appropriate FDA approved food dye added to match the color of the test agent. There will be no difference in the treatment and control varnishes except for the povidone iodine. Standard varnish: Topical application of test varnish to the teeth 4 times per year
Child Response to First Treatment	2.3 units on a scale Standard Deviation 1.2	2.5 units on a scale Standard Deviation 1.3

SECONDARY outcome

Timeframe: After fifth treatment visit

Population: Analysis population based on participants who received the fifth varnish application and completed the Facial Image Scale.

Outcome measures

Outcome measures
Measure	Test Varnish n=135 Participants Advantage Anti-Caries Varnish. The active ingredients are Povidone Iodine and Sodium Fluoride . Test varnish: Topical application of test varnish to the teeth 4 times per year.	Standard Varnish n=137 Participants The active control varnish will be the same fluoride varnish without iodine with an appropriate FDA approved food dye added to match the color of the test agent. There will be no difference in the treatment and control varnishes except for the povidone iodine. Standard varnish: Topical application of test varnish to the teeth 4 times per year
Child Response to Fifth Treatment	2.2 units on a scale Standard Deviation 1.1	2.1 units on a scale Standard Deviation 1.2

Adverse Events

Test Varnish

Serious events: 3 serious events

Other events: 43 other events

Deaths: 0 deaths

Standard Varnish

Serious events: 2 serious events

Other events: 49 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Test Varnish n=142 participants at risk Advantage Anti-Caries Varnish. The active ingredients are Povidone Iodine and Sodium Fluoride . Test varnish: Topical application of test varnish to the teeth 4 times per year.	Standard Varnish n=142 participants at risk The active control varnish will be the same fluoride varnish without iodine with an appropriate FDA approved food dye added to match the color of the test agent. There will be no difference in the treatment and control varnishes except for the povidone iodine. Standard varnish: Topical application of test varnish to the teeth 4 times per year
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/142 • 24 months	0.70% 1/142 • Number of events 1 • 24 months
Injury, poisoning and procedural complications fracture, arm	0.00% 0/142 • 24 months	0.70% 1/142 • Number of events 1 • 24 months
Musculoskeletal and connective tissue disorders Swelling, pain in knee	0.70% 1/142 • Number of events 1 • 24 months	0.00% 0/142 • 24 months
Infections and infestations tonsilitis	0.70% 1/142 • Number of events 1 • 24 months	0.00% 0/142 • 24 months
Cardiac disorders rheumatic heart disease	0.70% 1/142 • Number of events 1 • 24 months	0.00% 0/142 • 24 months

Other adverse events

Other adverse events
Measure	Test Varnish n=142 participants at risk Advantage Anti-Caries Varnish. The active ingredients are Povidone Iodine and Sodium Fluoride . Test varnish: Topical application of test varnish to the teeth 4 times per year.	Standard Varnish n=142 participants at risk The active control varnish will be the same fluoride varnish without iodine with an appropriate FDA approved food dye added to match the color of the test agent. There will be no difference in the treatment and control varnishes except for the povidone iodine. Standard varnish: Topical application of test varnish to the teeth 4 times per year
Infections and infestations Flu	21.1% 30/142 • Number of events 35 • 24 months	19.0% 27/142 • Number of events 33 • 24 months
Respiratory, thoracic and mediastinal disorders Cough	5.6% 8/142 • Number of events 9 • 24 months	7.7% 11/142 • Number of events 11 • 24 months
Respiratory, thoracic and mediastinal disorders Cough & fever	3.5% 5/142 • Number of events 5 • 24 months	7.7% 11/142 • Number of events 11 • 24 months

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

Measure	Test Varnish n=142 Participants Advantage Anti-Caries Varnish. The active ingredients are Povidone Iodine and Sodium Fluoride . Test varnish: Topical application of test varnish to the teeth 4 times per year.	Standard Varnish n=142 Participants The active control varnish will be the same fluoride varnish without iodine with an appropriate FDA approved food dye added to match the color of the test agent. There will be no difference in the treatment and control varnishes except for the povidone iodine. Standard varnish: Topical application of test varnish to the teeth 4 times per year	Total n=284 Participants Total of all reporting groups
Age, Categorical <=18 years	142 Participants n=5 Participants	142 Participants n=7 Participants	284 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	76 Participants n=5 Participants	64 Participants n=7 Participants	140 Participants n=5 Participants
Sex: Female, Male Male	66 Participants n=5 Participants	78 Participants n=7 Participants	144 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	142 Participants n=5 Participants	142 Participants n=7 Participants	284 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	142 Participants n=5 Participants	142 Participants n=7 Participants	284 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment Micronesia	142 participants n=5 Participants	142 participants n=7 Participants	284 participants n=5 Participants