- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03446690
MI Varnish for the Prevention of White Spot Lesions
June 22, 2023 updated by: Chung How Kau, University of Alabama at Birmingham
The Use of MI Varnish for the Prevention and Reduction of White Spot Lesions in Orthodontic Treatment
The current study aimed to determine if MI Varnish has an effect in preventing the formation of white spot lesions for patients undergoing orthodontic treatment.
33 subjects were prospectively recruited for the project as the MI Varnish group, with a control group of 29 orthodontically treated subjects who received routine treatment and oral hygiene regimes.Difference in prevention of white spot formation between the control and the study groups were evaluated through photographic records and clinical examination by using the Enamel Decalcification Index (EDI) scores.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Orthodontists face 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.
A new product, MI Varnish, is current available and has been shown in some initial case reports to be useful in reducing white spot lesions.
It contains a special milk-derived protein RECALDENT TM (CPP-ACP) in which the casein phosphopeptides (CPP) bind to teeth, dentin, and oral mucosa while the amorphous calcium phosphate (ACP) releases calcium and phosphate.
The current study aimed to determine if MI Varnish has an effect in preventing the formation of white spot lesions for patients undergoing orthodontic treatment.
33 subjects were prospectively recruited for the project as the MI Varnish group, with a control group of 29 orthodontically treated subjects who received routine treatment and oral hygiene regimes.
The study group received the MI Varnish on the day of bracket bonding.
Subjects were recalled initially for 4 weeks (twice) and then at 3 monthly intervals.
Difference in prevention of white spot formation between the control and the study groups were evaluated through photographic records and clinical examination by using the Enamel Decalcification Index (EDI) scores.
Study Type
Interventional
Enrollment (Actual)
62
Phase
- Phase 4
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Patients seeking orthodontic treatment and receiving routine treatment and oral hygiene regimes.
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 or any other investigational device;
- Patient plans to relocate or move within six months of enrollment.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: MI Varnish Group
33 subjects were prospectively recruited for the project in the MI Varnish group.
All subjects will be patients seeking orthodontic treatment at the Department of Orthodontics, UAB.
MI Varnish were applied on their teeth initially for 4 weeks (twice) and then 3 monthly intervals.
|
MI Varnish with RECALDENT™ (CPP-ACP) enhances enamel acid resistance and boosts salivary fluoride levels.
This product remains on the teeth longer than other fluoride varnishes and contains high levels of fluoride and calcium released in the oral cavity.
The difference is in the RECALDENT™ (CPP-ACP), which makes MI Varnish a natural and unique choice for your patients.
Casein phosphopeptides (CPP) naturally occurs in milk casein; Amorphous Calcium Phosphate (ACP), which is found in the RECALDENT™, is also the source of calcium and phosphate.
In the oral cavity, CPP binds to oral surfaces such as teeth, dentin, oral mucosa and biofilm.
Calcium and phosphate ions are the building blocks for healthy teeth and MI Varnish delivers bioavailable calcium and phosphate ions into the saliva.
|
Other: Control group
A control group was comprised of 29 orthodontically treated subjects who received routine treatment and oral hygiene regimes.
All subjects will be patients seeking orthodontic treatment at the Department of Orthodontics, School of Dentistry, University of Alabama at Birmingham.
No intervention for this group.
|
Participants received routine treatment and oral hygiene regimes.
No intervention for this group.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Enamel Decalcification Index (EDI) Scores
Time Frame: Photographs were taken for 4 times at monthly intervals. EDI scores were measured and assessed at 1, 2, 3 and 4 months, Month 4 reported. 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.Enamel decalcification index calculation: The facial surface of each tooth was divided into 4 areas (m, Mesial; g, gingival; d, distal; o, occlusal).
A score was allocated for each area of each tooth: 0, no decalcification, to 3, decalcifications covering 100% of the area at each time period.
Analysis was done at the tooth level, aggregating the enamel decalcification scores from all four areas, creating an EDI for each tooth ranging potentially from 0 to 12. Higher EDI scores indicate more decalcification of teeth and represent a worse outcome.
|
Photographs were taken for 4 times at monthly intervals. EDI scores were measured and assessed at 1, 2, 3 and 4 months, Month 4 reported. The duration of the observation is an average of 4 months.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Chung H Kau, BDS, PhD, University of Alabama at Birmingham
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2015
Primary Completion (Actual)
November 1, 2015
Study Completion (Actual)
January 1, 2016
Study Registration Dates
First Submitted
February 14, 2018
First Submitted That Met QC Criteria
February 20, 2018
First Posted (Actual)
February 27, 2018
Study Record Updates
Last Update Posted (Actual)
June 26, 2023
Last Update Submitted That Met QC Criteria
June 22, 2023
Last Verified
June 1, 2023
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 1135815
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on White Spot Lesion
-
Al-Azhar UniversityEnrolling by invitation
-
Texas A&M UniversityCompletedWhite Spot LesionUnited States
-
Izmir Katip Celebi UniversityCompletedRemineralization | White Spot LesionTurkey
-
Universitat Internacional de CatalunyaCompleted
-
EgymedicalpediaCompleted
-
Hams Hamed AbdelrahmanCompletedWhite Spot LesionEgypt
-
Damascus UniversityCompletedWhite Spot LesionSyrian Arab Republic
-
Riyadh Elm UniversityNot yet recruitingWhite Spot Lesion
-
October University for Modern Sciences and ArtsCompletedWhite Spot LesionEgypt
-
Jordan University of Science and TechnologyActive, not recruitingWhite Spot LesionJordan
Clinical Trials on MI Varnish
-
Texas A&M UniversityCompletedWhite Spot LesionUnited States
-
Cairo UniversityUnknownRemineralization | White Spot Lesion | Caries,DentalEgypt
-
Izmir Katip Celebi UniversityCompletedProximal CariesTurkey
-
Cairo UniversityUnknown
-
King Abdulaziz UniversityUnknown
-
Indira Gandhi Institute of Dental ScienceCompletedEvaluation of Remineralizing Efficacy of Combination Varnishes on White Spot Lesions in ECC ChildrenChild | Early Childhood Caries
-
Nourhan M.AlyAlexandria UniversityCompleted
-
University of WashingtonPacific NW Dental Practice-Based Research NetworkCompletedTooth DemineralizationUnited States
-
Merve Erkmen AlmazCompletedEarly Childhood Caries