White Spot LesionNCT03440996
Comparison of Three Toothpastes for the Prevention and Reduction of White Spot Lesions
A study testing Clinpro™ 5000, Clinpro™ Tooth Crème and MI-Paste Plus in people with White Spot Lesion and Orthodontic Treatment, run by University of Alabama at Birmingham at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- White Spot Lesion, Orthodontic Treatment, Decalcification; Teeth
- What is being tested?
- Clinpro™ 5000, Clinpro™ Tooth Crème and MI-Paste Plus
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jan 2011to 30 Dec 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 60 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35294
About this study
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
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.
Read the 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.
- Being tested
- Clinpro™ 5000, Clinpro™ Tooth Crème, MI-Paste Plus
- Keywords
- toothpaste
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinpro™ 5000Other
Also called Toothpaste produced by 3M ESPE.
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 CrèmeOther
Also called Toothpaste produced by 3M ESPE.
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 PlusOther
Also called Toothpaste produced by GC America
MI-Paste Plus is a widely used anti-cavity toothpaste on the market and it is used as a control group in this study.
| Study group | Role | What they receive |
|---|---|---|
| Clinpro™ 5000 | Experimental | Participants will use Clinpro™ 5000 to brush their teeth for two minutes twice daily for 4 months. Receives: Other: Clinpro™ 5000 |
| Clinpro™ Tooth Crème | Experimental | Participants will use Clinpro™ Tooth Crème to brush their teeth for two minutes twice daily for 4 months. Receives: Other: Clinpro™ Tooth Crème |
| MI-Paste Plus | Active comparator | Participants will use MI-Paste Plus to brush their teeth for two minutes twice daily for 4 months. Receives: Other: MI-Paste Plus |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2018
- Study start14 Jan 2011
- Primary completion30 Jun 2011
- Study completion30 Dec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for White Spot LesionStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chung How Kau, University of Alabama at Birmingham
- Investigators
- Chung H Kau, BDS, PhD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03440996
- Sponsor's protocol ID
- 1122614
- Status last verified
- Feb 2018
- First submitted
- 14 Feb 2018
- Last updated
- 22 Feb 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 30719933
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03440996
- Acronym / sponsor ID
- 1122614
- Keywords
- toothpaste
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 14 Jan 2011 (actual)
- Primary completion
- 30 Jun 2011 (actual)
- Study completion
- 30 Dec 2011 (actual)
- First posted
- 22 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Clinpro™ 5000 | Experimental | Other: Clinpro™ 5000Participants will use Clinpro™ 5000 to brush their teeth for two minutes twice daily for 4 months. |
| Clinpro™ Tooth Crème | Experimental | Other: Clinpro™ Tooth CrèmeParticipants will use Clinpro™ Tooth Crème to brush their teeth for two minutes twice daily for 4 months. |
| MI-Paste Plus | Active comparator | Other: MI-Paste PlusParticipants will use MI-Paste Plus to brush their teeth for two minutes twice daily for 4 months. |
Who may qualify
- Ages
- 12 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clinpro™ 5000Also: Toothpaste produced by 3M ESPE.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 | Clinpro™ 5000 |
| Clinpro™ Tooth CrèmeAlso: Toothpaste produced by 3M ESPE.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 | Clinpro™ Tooth Crème |
| MI-Paste PlusAlso: Toothpaste produced by GC AmericaMI-Paste Plus is a widely used anti-cavity toothpaste on the market and it is used as a control group in this study. | Other | MI-Paste Plus |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2018.
- Derived from this study: PubMed 30719933Kau 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chung H Kau, BDS, PhD principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clinpro™ 5000, Clinpro™ Tooth Crème and MI-Paste Plus in people with White Spot Lesion and Orthodontic Treatment, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03440996, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2018.