This trial is active, not recruiting.

Condition white spot lesions
Treatments vanish varnish, oral b minute-gel
Sponsor 3M
Collaborator University of Tennessee Health Science Center
Start date February 2012
End date October 2014
Trial size 30 participants
Trial identifier NCT01500187, CR-11-011, ORTHO2011-01


Study will look at ability of fluoride varnish to remineralize white spot enamel lesions that can occur around the edge of fixed orthodontic brackets.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose treatment
(Active Comparator)
Oral B Minute-Gel, fluoride gel
oral b minute-gel
Fluoride gel
Vanish varnish, 5% sodium fluoride varnish with tricalcium phosphate
vanish varnish Vanish White Varnish
5% sodium fluoride varnish with tricalcium phosphate

Primary Outcomes

Remineralization of enamel white spot lesion
time frame: 6 months

Eligibility Criteria

Male or female participants from 12 years up to 16 years old.

Inclusion Criteria: - no systemic disease - has completed fixed orthodontic treatment, brackets debonded - has at least two teeth with whitre spot lesions - has received conventional periodontal therapy after orthodontic tretament Exclusion Criteria: - presence of enamel hypoplasia or dental fluorosis - presence of tetracycline pigmentation - periodontal pocketing of 3mm or greater - taking antibiotics - presence of carious cavities - allergy to fluoride gel / varnish being used in study

Additional Information

Official title Fluoride Varnish Application for Treatment of White Spot Lesion After Fixed Orthodontic Treatment. A Pilot Study.
Principal investigator Franklin Garcia-Godoy, DDS, MS
Description To determine the efficacy of 5% sodium fluoride varnish with tricalcium phosphate in reverting white spot lesions after fixed orthodontic treatment, compared with a fluoride gel.
Trial information was received from ClinicalTrials.gov and was last updated in December 2013.
Information provided to ClinicalTrials.gov by 3M.