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

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The University of Alabama at Birmingham

Status

Completed

Conditions

Orthodontic Treatment
Decalcification; Teeth
White Spot Lesion

Treatments

Other: MI-Paste Plus
Other: Clinpro™ Tooth Crème
Other: Clinpro™ 5000

Study type

Interventional

Funder types

Other

Identifiers

NCT03440996
1122614

Details and patient eligibility

About

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.

Full description

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.

Enrollment

90 patients

Sex

All

Ages

12 to 60 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

90 participants in 3 patient groups

Clinpro™ 5000
Experimental group
Description:
Participants will use Clinpro™ 5000 to brush their teeth for two minutes twice daily for 4 months.
Treatment:
Other: Clinpro™ 5000
Clinpro™ Tooth Crème
Experimental group
Description:
Participants will use Clinpro™ Tooth Crème to brush their teeth for two minutes twice daily for 4 months.
Treatment:
Other: Clinpro™ Tooth Crème
MI-Paste Plus
Active Comparator group
Description:
Participants will use MI-Paste Plus to brush their teeth for two minutes twice daily for 4 months.
Treatment:
Other: MI-Paste Plus

Trial documents
2

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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