Trial Outcomes & Findings for Fluoride Varnish for Treatment of White Spot Lesions (NCT NCT01500187)

Results Overview

Outcome of fluoride varnish or gel application to white spot lesions as measured by DIAGNOdent device after orthodontic debonding. Values shown represent the mean DIAGNOdent reading. The DIAGNOdent scale spans values from 0 to 30+ where larger values indicate higher levels of demineralization.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

38 participants

Primary outcome timeframe

Baseline, Three and Six Month

Results posted on

2024-10-02

Participant Flow

Unit of analysis: Teeth

Participant milestones

Participant milestones
Measure	Pediagel 1.23% Acidulated Phosphate Fluoride Gel (Preventech)	Vanish Varnish 5% sodium fluoride varnish with tricalcium phosphate (3M)
Overall Study STARTED	23 106	15 74
Overall Study COMPLETED	17 76	15 72
Overall Study NOT COMPLETED	6 30	0 2

Reasons for withdrawal

Reasons for withdrawal
Measure	Pediagel 1.23% Acidulated Phosphate Fluoride Gel (Preventech)	Vanish Varnish 5% sodium fluoride varnish with tricalcium phosphate (3M)
Overall Study Lost to Follow-up	6	0

Baseline Characteristics

Fluoride Varnish for Treatment of White Spot Lesions

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Pediagel n=106 Teeth 1.23% Acidulated Phosphate Fluoride Gel	Vanish Varnish n=74 Teeth 5% sodium fluoride varnish with tricalcium phosphate	Total n=180 Teeth Total of all reporting groups
Age, Categorical <=18 years	23 Participants n=5 Participants	15 Participants n=7 Participants	38 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	11 Participants n=5 Participants	8 Participants n=7 Participants	19 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants	7 Participants n=7 Participants	19 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, Three and Six Month

Outcome of fluoride varnish or gel application to white spot lesions as measured by DIAGNOdent device after orthodontic debonding. Values shown represent the mean DIAGNOdent reading. The DIAGNOdent scale spans values from 0 to 30+ where larger values indicate higher levels of demineralization.

Outcome measures

Outcome measures
Measure	Pediagel n=76 Teeth 1.23% Acidulated phosphate fluoride	Vanish Varnish n=72 Teeth 5% sodium fluoride varnish with tricalcium phosphate
DIAGNOdent Readings at Baseline, Three and Six Months - Intergroup Comparison Baseline	5.10 units on a scale Standard Deviation 2.67	6.01 units on a scale Standard Deviation 4.17
DIAGNOdent Readings at Baseline, Three and Six Months - Intergroup Comparison Three Months	4.08 units on a scale Standard Deviation 2.32	5.50 units on a scale Standard Deviation 3.81
DIAGNOdent Readings at Baseline, Three and Six Months - Intergroup Comparison Six Months	3.52 units on a scale Standard Deviation 2.46	3.95 units on a scale Standard Deviation 2.97

Adverse Events

Group 2

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Group 1

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

Franklin Garcia-Godoy DDDS, MS PhD

University of Health Science Center

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place