Trial Outcomes & Findings for Dental Office Prevention Strategies for Children (NCT NCT02004990)

Results Overview

Modified plaque index for the mixed dentition scale is 0-2 (0=best 2=worse)

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

12 participants

Primary outcome timeframe

2-4 weeks

Results posted on

2017-03-10

Participant Flow

Participant milestones

Participant milestones
Measure	Single Cleansing Procedure of 10% Povidone Iodine Cleansing 10% povidone iodine cleansing Single cleansing procedure of 10% Povidone Iodine: Single cleansing procedure of 10% Povidone Iodine prior to an in-office 5% Sodium Fluoride varnish application
Overall Study STARTED	12
Overall Study COMPLETED	12
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Dental Office Prevention Strategies for Children

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Single Cleansing Procedure of 10% Povidone Iodine Cleansing n=12 Participants 10% povidone iodine cleansing Single cleansing procedure of 10% Povidone Iodine: Single cleansing procedure of 10% Povidone Iodine prior to an in-office 5% Sodium Fluoride varnish application
Age, Categorical <=18 years	12 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=93 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants
Sex: Female, Male Female	3 Participants n=93 Participants
Sex: Female, Male Male	9 Participants n=93 Participants

PRIMARY outcome

Timeframe: 2-4 weeks

Modified plaque index for the mixed dentition scale is 0-2 (0=best 2=worse)

Outcome measures

Outcome measures
Measure	Single Cleansing Procedure of 10% Povidone Iodine Cleansing n=12 Participants 10% povidone iodine cleansing Single cleansing procedure of 10% Povidone Iodine: Single cleansing procedure of 10% Povidone Iodine prior to an in-office 5% Sodium Fluoride varnish application
Dental Plaque Levels Measures on Scale of 0-2	0.391 units on a scale Standard Deviation 0.126

SECONDARY outcome

Timeframe: 2-4 weeks

Dental plaque is a multispecies bacterial biofilm and the specific bacteria populating this biofilm will be measured. Measurement will be change in thickness of the biofilm

Outcome measures

Outcome measures
Measure	Single Cleansing Procedure of 10% Povidone Iodine Cleansing n=12 Participants 10% povidone iodine cleansing Single cleansing procedure of 10% Povidone Iodine: Single cleansing procedure of 10% Povidone Iodine prior to an in-office 5% Sodium Fluoride varnish application
Dental Plaque Composition Measured by Numbers of Bacteria Present	1.25 micrometers Standard Deviation .04

Adverse Events

Single Cleansing Procedure of 10% Povidone Iodine Cleansing

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

Robert S. Jones DDS PhD

University of Minnesota

Phone: 612-626-2900

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place