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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03440996
Recruitment Status : Completed
First Posted : February 22, 2018
Last Update Posted : February 22, 2018
Sponsor:
Information provided by (Responsible Party):
Chung How Kau, University of Alabama at Birmingham

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
White Spot Lesion Orthodontic Treatment Decalcification; Teeth Other: Clinpro™ 5000 Other: Clinpro™ Tooth Crème Other: MI-Paste Plus Not Applicable

Detailed 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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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 (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: 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
Actual Study Start Date : January 14, 2011
Actual Primary Completion Date : June 30, 2011
Actual Study Completion Date : December 30, 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Orthodontia Rashes

Arms and Interventions
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Arm Intervention/treatment
Experimental: Clinpro™ 5000
Participants will use Clinpro™ 5000 to brush their teeth for two minutes twice daily for 4 months.
 Other: Clinpro™ 5000
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.
Other Name: Toothpaste produced by 3M ESPE.
Experimental: Clinpro™ Tooth Crème
Participants will use Clinpro™ Tooth Crème to brush their teeth for two minutes twice daily for 4 months.
 Other: Clinpro™ Tooth Crème
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.
Other Name: Toothpaste produced by 3M ESPE.
Active Comparator: MI-Paste Plus
Participants will use MI-Paste Plus to brush their teeth for two minutes twice daily for 4 months.
 Other: MI-Paste Plus
MI-Paste Plus is a widely used anti-cavity toothpaste on the market and it is used as a control group in this study.
Other Name: Toothpaste produced by GC America


Outcome Measures
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Primary Outcome Measures :
  1. Photographic records and clinical examination [ 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. ]
    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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03440996


Locations
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United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
Sponsors and Collaborators
University of Alabama at Birmingham
Investigators
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Principal Investigator: Chung H Kau, BDS, PhD University of Alabama at Birmingham
  Study Documents (Full-Text)

Documents provided by Chung How Kau, University of Alabama at Birmingham:
Study Protocol  [PDF] February 23, 2011
Statistical Analysis Plan  [PDF] February 23, 2011

More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Chung How Kau, Professor and Chairman, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT03440996    
Other Study ID Numbers: 1122614
First Posted: February 22, 2018    Key Record Dates
Last Update Posted: February 22, 2018
Last Verified: February 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Chung How Kau, University of Alabama at Birmingham:
toothpaste
Additional relevant MeSH terms:
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Listerine
Sodium Fluoride
Cariostatic Agents
Protective Agents
 Physiological Effects of Drugs
Anti-Infective Agents, Local
Anti-Infective Agents