MI Varnish and MI Paste Plus in a Caries Prevention and Remineralization Study (GC-WS)

April 8, 2020 updated by: University of California, San Francisco

The objective of this clinical study is to evaluate the efficacy of multiple applications of MI Varnish in combination with MI Paste Plus in caries protection and remineralization in comparison to the use of a control (Crest 1,100ppm Fluoride tooth paste, Fluoride rinse recommendation) in orthodontic patients in a randomized, single blind, prospective, controlled clinical trial over 12 months.

The effect will be measured by white spot lesion regression and prevention as lesion count. Lesions will be scored using the Enamel Decalcification Index (EDI) area evaluation scheme (primary outcome), International Caries Detection and Assessment System (ICDAS), the caries lesion activity criteria (Nyvad criteria; Bente Nyvad, Scandinavian Researcher), and Quantitative Light Fluorescence (QLF, Inspektor Pro, Netherlands)/SOPROLIFE (SOPROLIFE fluorescence camera system, Acteon, France) evaluation in maxillary and mandibular anterior teeth with orthodontic brackets in treatment and control groups.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The study is designed as randomized, single blind, prospective, clinical trial over 12 months. The subjects for this study will be recruited from the University of California at San Francisco UCSF, School of Dentistry, Orthodontic Clinic.

Participants in the study will be patients, who are in orthodontic treatment or will start orthodontic treatment; subjects must have full fixed appliances, with brackets bonded to the buccal surfaces of the maxillary and mandibular incisors, canines and first bicuspids. Subjects will be of moderate or high caries risk according to Caries Risk Assessment and ATP (Adenosine triphosphate) bacteria testing. Subjects will present with at least two active white spot lesions on his/her anterior teeth at the start of the study. The age limitation is ≥ 11 years.

The subjects will be randomly assigned to 1) Experimental group: MI Varnish and MI Paste Plus or 2) Control standard of care group: 1,100 ppm Fluoride tooth paste and recommendation to use OTC (Over-the-counter) Fluoride-rinse in the evening at home.

The clinical study investigator will evaluate the labial/buccal surfaces of upper and lower anterior teeth (first bicuspid to first bicuspid) for white spot lesions (WSL) at baseline and at the end of 3, 6, and 12 months. Newly formed lesions and changes in existing white spot lesions will be documented (using Enamel Decalcification Index (EDI), ICDAS II, light digital photographs and blue fluorescence photography SOPROLIFE and QLF- Quantitative Light Fluorescence).

All subjects will receive one professional tooth cleaning at baseline and at each other evaluation office visit to allow WSL evaluation (cleaning with ultrasonic device, and prophylaxis brush) and treatment application.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94143
        • UCSF School of Dentistry - Dental Offices in Bay Area

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

11 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • age 11 or older,
  • good health,
  • either gender
  • present with at least two active white spot lesions on his/her anterior teeth at the start of the study
  • have a moderate or high caries risk according to CAMBRA (Caries Management By Risk Assessment) rules
  • require at least 12 additional months of full fixed appliance therapy from the time they are recruited for the study
  • able to cooperate for treatment in the dental chair and follow at-home instructions
  • have an understanding of the study
  • willing to comply with all study procedures and protocols
  • patient participant is able to provide written informed consent in English; if the participant is a minor, the parent/guardian is able to provide written informed consent in English and the patient participant is able to provide written assent in English
  • patient participant or if a minor, the parent/guardian, is willing to sign the "Authorization for Release of Personal Health Information and Use of Personally Unidentified Study Data for Research" form; data will only be used for research
  • verifiable records of bonding with Transbond Plus Self-Etching Primer (3M Unitek, Monrovia, CA) and Transbond Light Cure Adhesive or similar products
  • verifiable records that "ProSeal" has not been applied at any time during the orthodontic treatment

Exclusion Criteria:

  • untreated cavitated lesions
  • extensive composite fillings on buccal surfaces of front teeth/first bicuspids or more than one dental crown on front teeth/first bicuspids
  • has sealants or fluoride releasing cements on the buccal surface of the anterior teeth
  • in-office fluoride treatment in the last three months
  • history of using any products containing CCP-ACP (casein phosphopeptides and amorphous calcium phosphate; MI paste, chewing gums or candies, etc.), prescription Fluoride products, and Chlorhexidine use in the last three months
  • intrinsic or extremely heavy extrinsic staining
  • any signs of fluorosis in the dentition
  • any signs of morphologic/anatomical/developmental deviations in the teeth
  • previous history of in office bleaching treatment
  • subject not willing to stop the use of any other oral hygiene product than those prescribed/suggested
  • has underlying systemic disease which could alter enamel composition or formation
  • suffering from systemic diseases, significant past or medical history with conditions that may affect oral health or oral flora (i.e. diabetes, HIV, heart conditions that require antibiotic prophylaxis)
  • use of medication causing dry mouth (extreme high caries risk)
  • subject is pregnant or lactating
  • milk protein allergy
  • any illness/condition that the investigator feels will affect the study outcome
  • will leave the area and will not be available for recall visits
  • subjects who are not willing to inform us about prospective visits of other dentist and will not allow us to discuss treatment with those dentist
  • subjects who are not willing to refrain from any additional professional tooth cleaning or any additional Fluoride application.

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: MI Paste & MI Varnish
MI past will be applied by the patient every night; MI varnish will be applied every three months in the office
Drug: CPP-ACP 5% sodium fluoride varnish & 900ppm fluoride paste

MI Paste & MI Varnish- in-office:

varnish application once every 3 months; at baseline, at the end of month 3, 6, and 9 (4 applications)

- at-home: brushing with regular 1,100ppm F-toothpaste, 2x per day and MI Paste Plus, home application after brushing in the evening; 3-5 minutes with in-home application tray
Active Comparator: Standard of Care
Subjects will use at home regal toothpaste every night and F-mouth rinse as recommended
Drug: 1,100pm F-toothpaste and 0.5%NaF rinse

Standard of care at-home:

Crest tooth brushing 2x per day - (recommendation OTC Fluoride-rinse in the evening at home 1x per day)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in White Spot Lesions Count - Enamel Decalcification Index (EDI)
Time Frame: Baseline and 12-months

The area evaluation scheme of the Enamel Decalcification Index (EDI) divides the buccal surface of each tooth into 4 quadrants and then registers the possible existence of a white spot lesion (decalcification) in each of these 4 quadrants. For each quadrant the lesion can be scaled as: 0 = no decalcification, 1 = decalcification covering <50% of the area, 2 = decalcification covering > 50% of the area, 3 = decalcifications covering 100% of the area or severe decalcification with cavitation. Thus, for each tooth the value can range between 0 and 12.

16 teeth per subject were evaluated, for each subject the value of each tooth was added - thus the range per one subject can be between 0 and 192.

A mean over all participants in one group was calculated. A higher score means a worse outcome.
Baseline and 12-months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in International Caries Detection and Assessment System (ICDAS II) to Score for Smooth Surfaces White Spot Lesions (WSL)
Time Frame: Baseline and 12-months

The International Caries Detection and Assessment System (ICDAS II) is a standardized method of caries lesion assessment.The score is based on apparent lesion severity, with scores from 0 to 6.The buccal surface of each tooth was divided into 4 quadrants, and for each quadrant a score was assigned with ICDAS scores: 0 = sound, 1 = first visual change in enamel, after air drying, 2 = distinct demineralization visual change in enamel, 3 = localized enamel breakdown due to caries with no visible dentin, 4 = surface with underlying dark shadow from dentin with or without enamel breakdown, 5 = distinct cavity with visible dentin, 6 = extensive cavity with visible dentin.

The ICDAS scores were calculated as the sum of the highest ICDAS scores assigned to each examined tooth per subject. 16 teeth per subject were evaluated, thus, for each subject the value can range between 0 and 96.

A mean over all participants in one group was calculated. A higher score means a worse outcome.
Baseline and 12-months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Lesion Activity, Nyvad Criteria
Time Frame: Baseline and 12-months
WS lesion activity will be determined using the Nyvad criteria;
Baseline and 12-months
Change in SOPROLIFE
Time Frame: Baseline and 12-months
fluorescence measurements using blue light fluorescence make WSLs visible for scoring;
Baseline and 12-months
Change in Quantitative Light Fluorescence (QLF)
Time Frame: Baseline and 12-months
Quantitative Light Fluorescence will be used to evaluate the WSL
Baseline and 12-months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of California, San Francisco

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Peter Rechmann, DMD, PhD, University of California, San Francisco

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 15, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 21, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 22, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 22, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 8, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • GCAmerica-WS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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.

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