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

• ClinicalTrials.gov Identifier: NCT03440996
• Recruitment Status: Completed
• First Posted: February 22, 2018
• Last Update Posted: February 22, 2018
• Sponsor: University of Alabama at Birmingham
• Information provided by (Responsible Party): Chung How Kau, University of Alabama at Birmingham

Tracking Information

• First Submitted Date: February 14, 2018
• First Posted Date: February 22, 2018
• Last Update Posted Date: February 22, 2018
• Actual Study Start Date: January 14, 2011
• Actual Primary Completion Date: June 30, 2011 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: February 14, 2018)

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.

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Comparison of Three Toothpastes for the Prevention and Reduction of White Spot Lesions
• 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
• 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.

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 Type: Interventional
• Study Phase: Not Applicable

Study Design

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

Condition

• White Spot Lesion
• Orthodontic Treatment
• Decalcification; Teeth

Intervention

• 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.
• 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.
• 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

Study Arms

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

• Publications *: Kau CH, Wang J, Palombini A, Abou-Kheir N, Christou T. Effect of fluoride dentifrices on white spot lesions during orthodontic treatment: A randomized trial. Angle Orthod. 2019 May;89(3):365-371. doi: 10.2319/051818-371.1. Epub 2019 Feb 5.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: February 14, 2018): 90
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: December 30, 2011
• Actual Primary Completion Date: June 30, 2011 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 12 Years to 60 Years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03440996
• Other Study ID Numbers: 1122614
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

• 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

• IPD Sharing Statement: Not Provided
• Current Responsible Party: Chung How Kau, University of Alabama at Birmingham
• Original Responsible Party: Same as current
• Current Study Sponsor: University of Alabama at Birmingham
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Chung H Kau, BDS, PhD; University of Alabama at Birmingham

• PRS Account: University of Alabama at Birmingham
• Verification Date: February 2018