Comparison of Three Toothpastes for the Prevention and Reduction of White Spot Lesions

During the course of orthodontic treatment, the practitioner normally faces two common
iatrogenic treatment side effects: root resorption and enamel decalcification, with the
latter occurring at a much higher frequency. While the processes that lead to enamel
demineralization are understood, methods to diminish or perhaps eliminate degradation of
enamel surfaces are being searched for. Several approaches have been formulated to counteract
demineralization of tooth structure. One approach involves patient compliance and consists of
in-depth oral hygiene instructions, in-office fluoride applications, and at-home fluoride
rinses, gels, and varnishes. An alternative approach, which possesses potential benefit
regardless of patient compliance, includes the use of fluoride-releasing agents, such as
composites, glass ionomers, sealants, and elastomeric ties.

Enamel decalcification or white spot formation, is a phenomenon occurring primarily on smooth
enamel surfaces of teeth, notably within the gingival third of the crown. Demineralized
enamel, the precursor to caries formation, can be attributed to fixed orthodontic appliances,
and prolonged exposure to bacterial plaque. Bacterial plaque promotes the accumulation of
acidic byproducts and demineralization that leads to successive changes in the optical
properties of subsurface demineralized enamel. Progression to clinically detectable white
spot lesions may occur as early as one month following the placement of orthodontic
appliances.

Two new anti-cavity toothpastes, Clinpro™ 5000 with 1.1% Sodium Fluoride and Clinpro™ Tooth
Crème with 0.21% Sodium Fluoride, are currently available and have been shown in some initial
case reports to be useful in the reduction of white spot lesions. Clinpro™ restores minerals
and helps you produce saliva. Both the Clinpro™ products are advanced formulas containing an
innovative tri-calcium phosphate ingredient. They are available exclusively from 3M ESPE.
Clinpro™ contains fluoride as well as calcium and phosphate, which are components naturally
found in saliva.

Thus, this study will compare Clinpro™ 5000 1.1% Sodium Fluoride Anti-Cavity Toothpaste,
Clinpro™ Tooth Crème, and MI-Paste Plus for the prevention and reduction of white spot
lesions during orthodontic treatment.

INCLUSION CRITERIA

1. Permanent dentition

2. Patients that in the opinion of the investigator will be compliant with the use of the
paste

3. Patients who have not used extensive fluoride regimes

4. 12 years and older

5. Subjects must use a non-fluoridated toothpaste (such as Tom's of Maine) for a one-week
period prior to starting this trial.

EXCLUSION CRITERIA

1. Any medical or dental condition that in the opinion of the investigator could impact
study results during the expected length of the study.

2. Patient is currently using any investigational drug.

3. Patient plans to relocate or move within six months of enrollment.

4. Patients who have or are currently undergoing fluoride treatment for white spot
lesions.

5. Patients with IgE Casein Allergy