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

Study Overview
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Brief Summary
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The purpose of the study is to determine if Clinpro™ 5000, Clinpro™ Tooth Crème, or MI-Paste Plus has an effect on the formation and resolution of white spot lesions for patients undergoing orthodontic treatment. This study will include 90 patients in the UAB Orthodontic Clinic.

Detailed Description
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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.

Official Title
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Comparison of 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 in Orthodontic Treatment

Conditions
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White Spot Lesion, Orthodontic Treatment, Decalcification; Teeth

Intervention / Treatment
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* Other: Clinpro™ 5000
* Other: Clinpro™ Tooth Crème
* Other: MI-Paste Plus


Participation Criteria
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Eligibility Criteria
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INCLUSION CRITERIA Permanent dentition Patients that in the opinion of the investigator will be compliant with the use of the paste Patients who have not used extensive fluoride regimes 12 years and older 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 Any medical or dental condition that in the opinion of the investigator could impact study results during the expected length of the study. Patient is currently using any investigational drug. Patient plans to relocate or move within six months of enrollment. Patients who have or are currently undergoing fluoride treatment for white spot lesions. Patients with IgE Casein Allergy

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Three groups of 30 subjects (one group with Clinpro™ 5000, one group with MI-Paste Plus, and one group with Clinpro™ Tooth Crème) each will be evaluated as a protocol for the reduction of white spot lesions at the start of orthodontic treatment. Subjects will be recruited through the Orthodontic Postgraduate Clinic at the University of Alabama at Birmingham School of Dentistry.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Clinpro™ 5000<br>Participants will use Clinpro™ 5000 to brush their teeth for two minutes twice daily for 4 months. | Other: Clinpro™ 5000<br>* Clinpro™ 5000 with 1.1% Sodium Fluoride is a new anti-cavity toothpaste, and is 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. The Clinpro™ products are advanced formulas containing an innovative tri-calcium phosphate ingredient. It is available exclusively from 3M ESPE. Clinpro™ contains fluoride as well as calcium and phosphate, which are components naturally found in saliva.<br>* Other names: Toothpaste produced by 3M ESPE.;|
| Experimental: Clinpro™ Tooth Crème<br>Participants will use Clinpro™ Tooth Crème to brush their teeth for two minutes twice daily for 4 months. | Other: Clinpro™ Tooth Crème<br>* Clinpro™ Tooth Crème with 0.21% Sodium Fluoride is a new anti-cavity toothpaste, and is 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. The Clinpro™ products are advanced formulas containing an innovative tri-calcium phosphate ingredient. It is available exclusively from 3M ESPE. Clinpro™ contains fluoride as well as calcium and phosphate, which are components naturally found in saliva.<br>* Other names: Toothpaste produced by 3M ESPE.;|
| Active Comparator: MI-Paste Plus<br>Participants will use MI-Paste Plus to brush their teeth for two minutes twice daily for 4 months. | Other: MI-Paste Plus<br>* MI-Paste Plus is a widely used anti-cavity toothpaste on the market and it is used as a control group in this study.<br>* Other names: Toothpaste produced by GC America;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Photographic records and clinical examination | Photographic records will be used to determine the improvements in the white spot lesions. A standard intra-oral photographic camera will be utilized and the photographs will be taken in a light controlled environment and photographs will be captured in a pre-set photographic protocol. The Enamel decalcification index (EDI) will be used to determine the number of white spot lesions present at each time frame. | Subjects will be reviewed every 4 weeks. Photographs will be taken for 4 times at monthly intervals. Changes will be compared and assessed. The duration of the observation is an average of 4 months. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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toothpaste