Comparison of Three Toothpastes for the Prevention and Reduction of White Spot Lesions
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
1 other identifier
interventional
90
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2011
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 14, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2011
CompletedFirst Submitted
Initial submission to the registry
February 14, 2018
CompletedFirst Posted
Study publicly available on registry
February 22, 2018
CompletedFebruary 22, 2018
February 1, 2018
6 months
February 14, 2018
February 14, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Study Arms (3)
Clinpro™ 5000
EXPERIMENTALParticipants will use Clinpro™ 5000 to brush their teeth for two minutes twice daily for 4 months.
Clinpro™ Tooth Crème
EXPERIMENTALParticipants will use Clinpro™ Tooth Crème to brush their teeth for two minutes twice daily for 4 months.
MI-Paste Plus
ACTIVE COMPARATORParticipants will use MI-Paste Plus to brush their teeth for two minutes twice daily for 4 months.
Interventions
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.
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.
MI-Paste Plus is a widely used anti-cavity toothpaste on the market and it is used as a control group in this study.
Eligibility Criteria
You may qualify if:
- 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
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
Related Publications (1)
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.
PMID: 30719933DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Chung H Kau, BDS, PhD
University of Alabama at Birmingham
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor and Chairman
Study Record Dates
First Submitted
February 14, 2018
First Posted
February 22, 2018
Study Start
January 14, 2011
Primary Completion
June 30, 2011
Study Completion
December 30, 2011
Last Updated
February 22, 2018
Record last verified: 2018-02