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
Phase: NA
Conditions: White Spot Lesion, Orthodontic Treatment, Decalcification; Teeth
Sponsor: University of Alabama at Birmingham

200 Clinpro™ -Protocol 
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Human Subjects Protocol (HSP) 
Form Version: October 15, 2008 
 
 You are applying for IRB review of the research described in this form. 
 To avoid delay, respond to all items in order and include all required approvals and documents. 
 To complete the form, click the underlined areas and type or paste in your text; double-click 
checkboxes to check/uncheck. For more tips, see www.uab.edu/irb/forms. 
 Mail or deliver all materials to AB 470, 701 20th Street South, Birmingham, AL 35294-0104. 
Indicate the type of review you are applying for: 
 Convened (Full) IRB or 
 Expedited—See the Expedited Category Review Sheet, and indicate the category(ies) 
here: 
1 
2 
3 
4 
5 
6 
7 
1. IRB Protocol 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 
2. Investigator, Contacts, Supervisors 
a. Name of Principal Investigator: Chung How Kau 
Degree(s)/Title: BDS, MScD, MBA, PhD, FDS, FAMS(Ortho), FFD (Ortho)/Professor & Chair  
 
Dept/Div: Orthodontics 
Mailing Address: SDB 305 
UAB ZIP:0007  
BlazerID: ckau 
 
Phone: 
4-1289 
Fax: 5-7590 
E-mail:ckau@uab.edu 
b. Name of Contact Person: 
Teri Baginski 
Title: Research Coordinator 
 
Phone: 
4-4547 
Fax: 5-7590 
E-mail: shadia@uab.edu 
Mailing Address (if different from that of PI, above): SDB 307, zip 0007 
INVESTIGATOR ASSURANCE STATEMENT & SIGNATURE 
By my signature as Principal Investigator, I acknowledge my responsibilities for this Human 
Subjects Protocol, including:  
 Certifying that I and any Co-Investigators or Other Investigators comply with reporting 
requirements of the UAB Conflict of Interest Review Board;  
 Certifying that the information, data, and/or specimens collected for the research will be 
used, disclosed and maintained in accordance with this protocol and UAB policies;  
 Following this protocol without modification unless (a) the IRB has approved changes prior 
to implementation or (b) it is necessary to eliminate an apparent, immediate hazard to a 
participant(s);  
 Verifying that all key personnel listed in the protocol and persons obtaining informed 
consent have completed initial IRB training and will complete continuing IRB training each 
year; 
 Verifying that all personnel are licensed/credentialed for the procedures they will be 
performing, if applicable; 
 Certifying that I and all key personnel have read the UAB Policy/Procedure to Ensure 
Prompt Reporting of Unanticipated Problems Involving Risks to Subjects or Others to the 
IRB, Institutional Officials, and Regulatory Agencies and understand the procedures for 
reporting;  
 Applying for continuing review of the protocol at least annually unless directed by the IRB 
to apply more frequently;  
 Conducting the protocol as represented here and in compliance with IRB determinations 
and all applicable local, state, and federal law and regulations; providing the IRB with all 
information necessary to review the protocol; refraining from protocol activities until 
receipt of initial and continuing formal IRB approval.  
 
 
Signature of Investigator: 
 
Date: 
 

200 Clinpro™ -Protocol 
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c. List all staff who will be involved with the design, conduct, and reporting of the research, their 
degree(s) and job title, and any additional qualifications. Include individuals who will be involved in 
the consent process. Repeat the table below for each individual. 
Note. For studies involving investigational drugs, include all investigators who will be listed on FDA 
Form 1572 and attach a copy, if applicable. Send the IRB a copy of Form 1572 anytime you update 
the form with the FDA. 
Role:  
Co- -OR- 
Other –AND/OR- 
Consent Process 
 Full Name: 
Teri Baginski 
Primary UAB Dept.: 
(Employer if not UAB)  
Orthodontics  
Degree(s) / Job Title: 
Research Coordinator 
Additional Qualifications 
pertinent to the study: 
      
 
d. Is the principal investigator a student, fellow, or resident?  
Yes 
No 
 
If Yes, complete items below and obtain signature of faculty advisor or supervisor: 
Supervisor's Name: 
      
Degree(s) / Job Title: 
      
Additional Qualifications 
pertinent to the study: 
      
Telephone: 
      
E-Mail: 
      
Signature:  
 
e. Describe the principal investigator's activities related to this protocol and provisions made 
by the PI to devote sufficient time to conduct the protocol: 
 
Dr. Kau 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. 
 
f. Is medical supervision required for this research?  
Yes 
No 
 
If Yes, who will provide the supervision? 
 PI will provide -OR- Name:      Telephone:      
 
If other than PI, obtain signature of person providing medical supervision: 
Signature:  
 
g. Describe the process that ensures that all persons assisting with the research are 
adequately informed about the protocol and their research-related duties and functions: 
IRB Training Certification 
 
3. Funding 
Is this study funded?  
Yes 
No 
If No, specify that costs of the study will be covered by funds from the UAB department or 
other source named:      
If Yes, attach one copy of completed application or request for funding sent to sponsor, and 
complete a-d.  
a. Title of Grant or Contract: 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 
b. PI of Grant or Contract: Chung How Kau 
c. Office of Grants & Contracts Administration Link or Tracking Number: T____________ 
 
(or enter "Pending" and provide upon receipt from OGCA) 
d. Sponsor, Funding Route (check and describe all that apply): 
 Government Agency or Agencies—Agency name(s):      
 NIH Coop. Group Trial—Group name:      

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 Private Nonprofit (e.g., Foundation)—Name:       
 Industry, investigator-initiated—Name: Indiana Nanotech 
Describe the funding arrangement: See Exhibit B of Clinical Trial Agreement 
between the Board of Trustees and Indiana Nanotech (attached)  
 
Note. Western IRB reviews industry-sponsored protocols unless the investigator 
initiated the research, or the study qualifies for expedited review or involves gene 
therapy.  
 UAB Departmental/Division Funds—Specify:      
 
4. Conflict of Interest—Human subjects research involving a disclosed financial 
interest is subject to IRB review following review by the Conflict of Interest Review 
Board.  
The following definitions are used for Item #4: 
Immediate family means spouse or a dependent of the employee. Dependent is any 
person, regardless of his or her legal residence or domicile, who receives 50% or more of his 
or her support from the public official or public employee or his or her spouse or who resided 
with the public official or public employee for more than 180 days during the reporting 
period. 
Financial Interest Related to the Research means financial interest in the sponsor, 
product or service being tested, or competitor of the sponsor. 
For each investigator and staff member involved in the design, conduct and reporting of the 
research (2a. and c.) answer the questions below: (Repeat the section below for each 
individual) 
Name: Chung How Kau 
Do you or your immediate family have any of the following? (check all that apply) 
 An ownership interest, stock options, or other equity interest related to the research of any 
value. 
  Compensation related to the research unless it meets two tests: 
 
Less than $10,000 in the past year when aggregated for the immediate family. 
 
Amount will not be affected by the outcome of the research.  
 Proprietary interest related to the research including, but not limited to, a patent, trademark, 
copyright, or licensing agreement.  
 Board of executive relationship related to the research, regardless of compensation. 
Name: Teri Baginski 
Do you or your immediate family have any of the following? (check all that apply) 
 An ownership interest, stock options, or other equity interest related to the research of any 
value. 
  Compensation related to the research unless it meets two tests: 
 
Less than $10,000 in the past year when aggregated for the immediate family. 
 
Amount will not be affected by the outcome of the research.  
 Proprietary interest related to the research including, but not limited to, a patent, trademark, 
copyright, or licensing agreement.  
 Board of executive relationship related to the research, regardless of compensation. 
If you checked any of the above, a financial interest disclosure has to be submitted to or currently be 
on file with the CIRB. A completed CIRB Evaluation has to be available before the IRB will conduct its 
review. 
 
5. Locations Involved 
a. Describe the facilities available for the conduct of the research. For research on UAB 
campus, include building names and room numbers: UAB Orthodontics Clinic, School of 
Dentistry Building third floor, SDB 305 
 
b. Indicate all "performance sites" that will provide space, services, facilities, potential or 
actual participants, or other support for this protocol.  
 The Kirklin Clinic (TKC) 

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 University of Alabama Hospital (UAHosp) 
 The Children's Hospital of Alabama (TCHA) 
 Callahan Eye Foundation Hospital (CEFH) 
 UAB Highlands 
 Jefferson County Dept. of Health (JCDH) 
 Birmingham Veterans Affairs Medical Center (BVAMC) 
 General Clinical Research Center (GCRC)—inpatient  
 General Clinical Research Center (GCRC)—outpatient  
 General Clinical Research Center (GCRC) at The Kirklin Clinic (TKC) 
 Other (i.e., Any performance site not listed above, including those covered by 
subcontracts related to this protocol)—Describe:      
 
c. Is this study a clinical trial requiring clinical services at one of the performance sites listed 
in Item b above? 
Yes 
No 
If Yes, Fiscal Approval Process (FAP)-designated units complete a FAP submission and 
send to fap@uab.edu. For more on the UAB FAP, see www.uab.edu/ohr.  
 
d. Is this a field study?  
Yes 
No 
If Yes, describe the community:  
 
e. Is the study to be undertaken within a school, business, or other institution that does not 
have an institutional review board?  
Yes 
No 
If Yes, attach a statement of any contacts with and approvals from the appropriate 
institution officials.  
 
Note. Documentation of all such approvals must be received by the UAB OIRB before IRB 
approval will be issued. 
 
f. Has this protocol or project been reviewed by another IRB, similar review board, or departmental 
review committee(s) that authorizes the use of its patient populations?  
Yes 
No 
 
If Yes, provide name of the review board(s):       
 
and for each board listed, enter either the date of latest approval(s) or “PENDING”:      
 
or reasons not approved:     . 
 
If this protocol is subsequently rejected or disapproved by another review board, the UAB IRB must 
be notified promptly. 
 
Attach copies of approvals/disapprovals. 
 
g. Will any of the participants be from the Birmingham Veterans Affairs Medical Center? 
Yes 
No 
If Yes, attach VA IRB approval or notification from the VA Research and Development Department 
that the study has been submitted to the VA IRB for review. 
 
h. Will the study be conducted at or recruit participants from the Jefferson County 
Department of Public Health (JCDH)?  
Yes 
No 
If Yes, attach notification that the protocol has been approved by JCDH or the Alabama 
Department of Public Health IRB. 
 
6. Multi-Site Studies 
a. Is the investigator the lead investigator of a multi-site study?  
Yes 
No 
b. Is UAB a coordinating site in a multi-site study? 
Yes 
No 
c. If you answered Yes to a or b, describe the management of information obtained in multi-
site research that might be relevant to the protection of participants. Include, at a 
minimum, the following items:  
o IRB approvals from other sites 

200 Clinpro™ -Protocol 
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o Unanticipated problems involving risks to participants or others. (For example, if 
there is an unanticipated problem involving risks to participants or others, which 
site is responsible for reporting it?)  
o Interim results. 
o Protocol modifications.  
      
 
7. Drugs: Will any drugs or supplements be used/studied in this protocol?  
Yes 
No 
If Yes, attach the Drug Review Sheet.  
 
8. Devices: Will any devices be studied in this protocol or used for a purpose other than for 
which they were approved by the FDA?  
Yes 
No  
If Yes, attach the Device Review Sheet. 
 
9. Special Approvals 
a. Does this project involve the use of radioisotopes?  
Yes 
No 
If Yes, attach documentation of approval from the Radiation Safety Division. 
 
b. Does this project include patients with contagious infections (e.g., mumps, measles, 
chickenpox, TB, meningitis)?  
Yes 
No 
If Yes, attach documentation of approval from Chairman of the Infection Control 
Committee of the appropriate facilities. 
 
c. Does this project involve obtaining remnant biopsy or surgical material from the 
Department of Pathology or any other source?  
Yes 
No 
If Yes, attach documentation of approval from the entity or individual providing the 
materials (e.g., the UAB Division of Anatomic Pathology Release of Pathologic Materials). 
 
d. Does this project require obtaining any remnant clinical laboratory specimens,  
Yes 
No 
body fluids, or microbiological isolates from the Department of Pathology or any other 
source? If Yes, attach documentation of approval from the entity or individual providing 
the materials (e.g., the UAB Division of Laboratory Medicine Release of Pathologic 
Materials). 
 
e. Does this project use stored (existing) specimens from a repository? 
Yes 
No 
If Yes, attach documentation of approval for use of specimens, and describe how existing 
specimens are labeled:       
 
10. Use of Specimens  
Does this project involve collecting specimens from participants and storing them for future 
research? 
Yes 
No 
If Yes, complete a-h. If no, skip to Item 11 
a. How will specimens be obtained, processed, distributed, and stored?  
      
 
b.  How will specimens be labeled (e.g., unique identifier, medical record number, Social 
Security number, name, date of birth)?  
      
 
c.  How will clinical data associated with the specimens be collected and stored?  
      
 
d.  What participant-identifying information will be collected and linked to the specimens?  
      

200 Clinpro™ -Protocol 
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e.  What steps will be taken to maximize the confidentiality of linked identifiers? For 
example, procedures could include using a password-protected computer database to 
link identifiers, with limited personnel knowledgeable of the password, or coded 
identifiers released without the ability to link to clinical data (also called "stripped" or 
"anonymized" specimens).  
      
 
f.  Will specimens be shared with other investigators in the future?  
Yes 
No  
If Yes, what identifiers, clinical information and demographic information will be 
shared; or will the specimens be stripped of identifiers (i.e., anonymized)? Also if yes, 
outline your procedure for assuring IRB approval for release and use prior to release of 
specimens.  
      
 
 Note. Investigators who receive and/or use these specimens must document approval 
from the appropriate IRB(s) before the specimens may be released. 
 
g.  Will biological samples be stored for future use? 
Yes 
No 
If Yes, indicate whether they will be used for the disease under study in this protocol 
or research on other diseases.  
      
 
h. Is genetic testing planned?  
Yes 
No 
If Yes, describe the planned testing here and see "DNA/Genetic Testing" in the 
Guidebook for consent requirements. 
      
 
 
11. Gene Therapy  
Does this project involve gene therapy or administering recombinant materials 
Yes 
No 
to humans? 
 
If Yes, submit the Gene Therapy Project Review Panel Report –OR- If this is a vaccine 
trial that is exempt from the NIH Guidelines For Research Involving Recombinant DNA 
Molecules, submit the Protocol Oversight Review Form For Clinical Vaccine Trials. 
 
12. HIPAA Privacy and Security  
 
Will the PI or others obtain, review, or make other use of participants' "personal health 
information" (i.e., information, whether oral or recorded in any form or medium that (a) is 
created or received by a health care provider and (b) relates to past, present, or future 
physical or mental health or condition of an individual; or provision of health care; or 
payment for provision of heath care)?  
Yes 
No 
 
 
If Yes, complete a-e as described. 
 
a. Will the data/information be stored or managed electronically 
Yes 
No 
(on a computer)? 
 
b. Is the principal investigator requesting that the UAB IRB waive patient 
Yes 
No 
HIPAA authorization from another institution or entity (e.g., insurance company, 
collaborating institution). If Yes, attach copy of privacy notices from institution/entity, 
and provide the name of institution/entity:       

200 Clinpro™ -Protocol 
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c. Indicate which, if any, of the listed entities below would provide information or maintain 
health information collected for this protocol and/or where health information that been 
collected will be stored/maintained. 
 The Kirklin Clinic 
 University of Alabama Hospital 
 The Children’s Hospital of Alabama 
 Callahan Eye Foundation Hospital 
 UAB Highlands 
 Jefferson County Department of Health  
 School of Dentistry 
 School of Health Professions 
 School of Medicine 
 School of Nursing 
 School of Optometry 
 University of Alabama Health Services Foundation 
 UAB Health Centers 
 Viva Health 
 Ophthalmology Services Foundation 
 Valley Foundation  
 Medical West - UAB Health System Affiliate 
 
Health System Information Systems: 
 HealthQuest 
 Cerner Millennium (Lab, Radiology, UED, Surgery) 
 EMMI - Master Member Index 
 Horizon - IPV (IVR/CDA/CRIS) 
 CareFlow Net 
 Eclipsys (PIN) 
 IMPACT 
 None—If None, skip to Item 13. 
 
d. Indicate which of the listed identifiers would be associated/linked with the protected health 
information (PHI) used for this protocol.  
 
 
 Names 
 Geographic subdivisions smaller than a State 
 Elements of dates (except year) related to an individual 
 Telephone numbers 
 Fax numbers 
 Email addresses 
 Social security numbers 
 Medical record numbers 
 Health plan beneficiary numbers 
 Account numbers 
 Certificate/license numbers 
 Vehicle identifiers and serial numbers 
 Device identifiers and serial numbers 
 Biometric identifiers 
 Web universal resource locators (URLs) 
 Internet protocol address numbers 
 Full-face photographic images  
 Any other unique identifying number—Describe:       

200 Clinpro™ -Protocol 
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Note. Codes are not identifying as long as the researcher cannot link the data to an 
individual 
 None—If None, skip to Item 13. 
 
e. Choose one plan to describe your use of the personal health information: 
 The data collected meet the specifications for a “limited data set” 
—Attach Data Use Agreement or Business Associate Agreement 
 
 Research staff will obtain authorization from each patient to use the information 
 
—Attach Patient Authorization form, complete except for patient name and IRB 
protocol number 
 
 PI requests Waiver of Patient Authorization to use the information 
 
—Attach Waiver of Authorization and Informed Consent form 
 
PROPOSED RESEARCH 
• The IRB will not accept grant applications and/or sponsor's protocols in lieu of the items as 
outlined below.  
• Do not separate responses from items. Instead, insert your response to each item below the 
item, keeping the information in the order of this form. 
• Number each page of the Human Subjects Protocol (i.e., Page X of Y). 
 
13. Purpose—in nontechnical, lay language  
Summarize the purpose and objectives of this protocol, including any related projects, in one 
short paragraph. 
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. 
14. Background—in nontechnical, lay language 
Summarize in 2-3 paragraphs past experimental and/or clinical findings leading to the 
formulation of this study. Include any relevant past or current research by the Principal 
Investigator. For drug and device studies summarize the previous results (i.e., Phase I/II 
or III studies). 
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. 

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Over the past thirty years, numerous studies have reported an increase in white spot 
lesions following orthodontic treatment. While a large portion of the non-orthodontically-
treated population experiences some form of decalcification, orthodontically treated 
patient populations have shown both an increase in new lesions and an increase in the 
severity of preexisting enamel opacities. Approximately, 50 percent of orthodontically 
treated patients develop white spot lesions in one or more teeth, compared with only 24 
percent in those not undergoing orthodontic treatment. 
Appliance removal halts white spot formation, and further elimination of cariogenic 
factors through diligent oral hygiene efforts inactivates incipient lesions, which may 
undergo regression over time. Complete elimination of lesions is unlikely due to the rapid 
remineralization of the enamel surface with high concentration fluorides, which restrict 
passage of ions into the deeper, more affected layers. Therefore, immediate application of 
high concentration of fluoride is not recommended. Decreased enamel discolorations may 
occur with time due to further remineralization, but regression is primarily credited to 
gradual surface abrasion of tooth structure. 
Such problems with enamel decalcification in orthodontic patients have influenced 
clinicians to search for a solution to orthodontic-associated demineralization. Because 
fluoride treatment immediately upon debonding is not advocated, clinicians have proposed 
fluoride treatment and fluoride-releasing materials at the commencement of therapy. 
Recommended solutions include oral hygiene instruction and reinforcement, fluoridated 
toothpastes, varnishes and mouthwashes, and fluoridated water supply. Lack of patient 
compliance hinders these efforts. 
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. 
This proprietary formula successfully integrates these components, enhancing, rather 
than compromising, the product’s performance. During the manufacturing process, a 
protective barrier is created around the calcium allowing it to coexist with the fluoride 
ions. Think of this as a bubble that transports the Tri-Calcium Phosphate to the teeth. As 
the toothpaste comes in contact with saliva during brushing, the barrier breaks down and 
makes the calcium, phosphate and fluoride readily available to the tooth. The tooth 
naturally absorbs these components, helping to prevent the initiation and further 
progression of demineralization and allowing remineralization to occur. 
15. Participants (Screening and Selection) 
a. How many participants are to be enrolled at UAB?90  
If multi-center study, total number at all centers:      
 
b. Describe the characteristics of anticipated or planned participants. 
Sex: both males and females 
Race/Ethnicity: all races 
Age: patients age 12-60 with adult dentition, i.e., permanent teeth (including 
adolescents) 
Health status: medically fit and well 
 
Note. If data from prior studies indicate differences between the genders or among 
racial/ethnic groups in the proposed research or if there are no data to support or to 
negate such differences, Phase 3 clinical trials will be required to include sufficient and 
appropriate entry of gender and racial/ethnic subgroups so that trends detected in the 
affected subgroups can be analyzed. If ethnic, racial, and gender estimates are not 

200 Clinpro™ -Protocol 
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Rev. 2/23/2011 
included in the protocol, a clear rationale must be provided for exclusion of this 
information. If prior evidence indicates that the results will not show gender or racial 
differences, researchers are not required to use gender or race/ethnicity as selection 
criteria for study participants. They are, however, encouraged to include these groups. 
See Section II. Policy of the NIH POLICY AND GUIDELINES ON THE INCLUSION OF 
WOMEN AND MINORITIES AS SUBJECTS IN CLINICAL RESEARCH – Amended, October, 
2001) for further details.  
 
c. From what population(s) will the participants be derived?  
patients coming to clinic for orthodontic treatment 
Describe your ability to obtain access to the proposed population that will allow 
recruitment of the necessary number of participants: 
orthodontic clinic 
Describe the inclusion/exclusion 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 
d. If participants will comprise more than one group or stratification, describe each group 
(e.g., treatment/intervention, placebo, controls, sham treatment) and provide the 
number of participants anticipated in each group. 
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. 
In order to fully evaluate each of the products, the selected product will be brushed on 
for two minutes twice daily for 4 months. After brushing on the product, patients should 
not rinse their mouths with water. Rather, they should just expectorate (spit) so they 
don’t clear out the actives from the product. Patient should also not eat or drink for 30 
minutes following the treatment. 
Subjects will be reviewed every 4 weeks. Subjects and study administrator will not 
know if the investigational paste or placebo is being administered. However, the PIs will 
know. Dr. Kau and Dr. Browne will randomly choose subjects by drawing individual slips of 
paper from an envelope on which 30 of each study product (i.e., Clinpro™ 5000, MI-Paste 
Plus, or Clinpro™ Tooth Crème) will be written. Each subject will receive product based 
upon the treatment type written on the paper selected by PIs. 

200 Clinpro™ -Protocol 
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Rev. 2/23/2011 
e. Indicate which, if any, of the special populations listed below will be involved in the 
protocol. Include the Special Populations Review Form (SPRF) if indicated. 
 Pregnant Women: Attach SPRF—Pregnant Women, Fetuses, Neonates/Nonviable 
Neonates 
 Fetuses: Attach SPRF—Pregnant Women, Fetuses, Neonates/Nonviable Neonates 
 Neonates/Nonviable Neonates: SPRF—Pregnant Women, Fetuses, Neonates/Nonviable 
Neonates 
 Prisoners: Attach SPRF—Prisoners  
 Minors (<19 years old): Attach SPRF—Minors 
 Employees or students at institution where research conducted 
 Persons who are temporarily decisionally impaired 
 Persons who are permanently decisionally impaired (e.g., mentally retarded) 
 Non-English Speakers 
For each box checked, describe why the group is included and the additional 
protections provided to protect the rights and welfare of these participants who are 
vulnerable to coercion:      
 
f. List any persons other than those directly involved in the study who will be at risk. If none, 
enter "None":None 
 
g. Describe the process (e.g., recruitment, chart review) that will be used to seek potential 
participants (e.g., individuals, records, specimens). Research recruitment by non-treating 
physicians/staff may require completion of Partial Waiver of Authorization for 
Recruitment/Screening. (See http://main.uab.edu/show.asp?durki=61981.) 
All orthodontic patients who meet the inclusion criteria will be invited to participate. 
 
h. If you will use recruitment materials (e.g., advertisements, flyers, letters) to reach 
potential participants, attach a copy of each item. If not, identify the source (e.g., 
databases) from which you will recruit participants.  
No, clinic patients only. 
 
i. Describe the procedures for screening potential participants.  
All orthodontic patients who meet the inclusion criteria will be invited to participate. 
 
16. Protocol Procedures, Methods, and Duration of the Study—in nontechnical 
language 
a.  Describe the study methodology that will affect the participants—particularly in regard to 
any inconvenience, danger, or discomfort. 
We will require all patients a two weeks washout period, during which time we will give 
them very specific brushing instructions for using a non-fluoridated product such as Tom’s 
of Maine toothpaste. These are the same instructions that we will require them to follow 
with whichever product that the patient will later be randomized to use in the trial, i.e. 
Clinpro™ 5000, Clinpro™ Tooth Crème, or MI-Paste Plus. This will ensure that all patients 
will use the same application technique, even though not all patients would be of the 
same level of potential decay. This washout period will last the same length of time for all 
patients, even though it will not begin simultaneously for all patients. 
Patient will brush on randomized product for two minutes twice daily for 4 months. 
After brushing on the product, patients should not rinse their mouths with water. Rather, 
they should just expectorate (spit). Patient should also not eat or drink for 30 minutes 
following the treatment. No other inconvenience, danger, or discomfort is expected as a 
result of study methodology. 
b. What is the probable length of time required for the entire study (i.e., recruitment through 
data analysis to study closure)? 

200 Clinpro™ -Protocol 
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16 weeks 
c. What is the total amount of time each participant will be involved? 
Subjects will be reviewed every 4 weeks. Subjects will be reviewed on four weekly 
intervals. 
d. If different phases are involved, what is the duration of each phase in which the 
participants will be involved? If no phases are involved, enter "not applicable." 
not applicable 

200 Clinpro™ -Protocol 
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Rev. 2/23/2011 
e.  List the procedures, the length of time each will take, and the frequency of repetition, and 
indicate whether each is done solely for research or would already be performed for 
treatment or diagnostic purposes (routine care) for the population. Insert additional table 
rows as needed.  
Procedure 
Length of Time 
Required of 
Participants 
Frequency of 
Repetition 
Research (Res) 
–OR- 
Routine Care 
A caries risk assessment will be 
used to determine the caries risk of 
all patients enrolled into the study.  
~10 minutes 
once, at start of 
treatment 
Res 
Routine 
Patient brushes on study paste at 
home. 
2 minutes 
twice daily 
Res 
Routine 
Patients will be reviewed every 4 
weeks 
 
twice, every 4 weeks 
Res 
Routine 
Patient answers Patient 
Satisfaction Questionnaire in UAB 
Orthodontic Clinic. 
10-15 minutes 
twice, at each 
follow-up visit 
Res 
Routine 
Patients will be evaluated for 
reduction of white spot lesions. 
~10 minutes 
once, at end of 
treatment 
Res 
Routine 
 
f.  Will an interview script or questionnaire be used?  
Yes 
No 
 
If Yes, attach a copy.  
 
g. Will participants incur any costs as a result of their participation?  
Yes 
No 
If Yes, describe the reason for and amount of each foreseeable cost. 
      
 
h.  Will participants be compensated?  
Yes 
No 
If Yes, complete i-v:  
i. Type: (e.g., cash, check, gift card, merchandise):Visa gift card 
ii. Amount or Value:$25.00 
iii. Method (e.g., mail, at visit): one-time issuance per patient, at clinic visit 
iv. Timing of Payments: (e.g., every visit, each month): upon completion of clinical trial 
v. Maximum Amount of Payments per Participant:$25.00 
 
17. Describe the potential benefits of the research.  
You may or may not benefit directly from taking part in this study. Although white 
spot lesions may appear less noticeable and teeth may feel less sensitive to hot or 
cold temperatures, this is not guaranteed. You will not benefit financially from any 
commercial gains from sales of any product resulting from this study. Research 
carried out on your results may lead to the development of marketable procedures, 
and any benefit from the commercial products will remain with the sponsor. 

200 Clinpro™ -Protocol 
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Rev. 2/23/2011 
18. Risks 
a. List the known risks—physical, psychological, social, economic, and/or legal—that 
participants may encounter as a result of procedures required in this protocol. Do not list 
risks resulting from standard-of-care procedures. Note: Risks included in this protocol 
document should be included in the written consent document.  
 
Skin allergic reaction (such as hives, swelling of the face, lips, tongue and/or throat 
which may cause difficulty in breathing or swallowing, and if not treated promptly 
could become life-threatening) due to contact with the device or its components. The 
types of materials that may come into contact with the skin include polyurethane, 
polycarbonate, neoprene, nylon, and styrene-butadiene. No latex is included in the 
OrthoPulse™. 
• 
If you are, or will be, using any medication, herbal or “natural” remedy, during the 
course of this study, please inform your study orthodontist immediately. Please check 
with the study orthodontist before you begin taking a new medication while in this 
study. 
• 
Low level laser light exposure to the eye (if the Face Frame is not properly worn during 
the treatment). Do not stare directly at the light, and close your eyes when taking the 
headset on and off. 
• 
By signing the Informed Consent, parent or guardian agrees to be present at (and 
monitor) all device applications of their child. 
b. Estimate the frequency, severity, and reversibility of each risk listed. 
upon contact, mild, discontinue contact 
 
c. Is this a therapeutic study or intervention?  
Yes 
No 
 
If Yes, complete the following items: 
i. Describe the standard of care in the setting where the research will be conducted:      
ii. Describe any other alternative treatments or interventions: You may choose not 
participate in the Clinpro™/MI-Paste Plus™ study and still receive routine orthodontic 
treatment in the UAB Orthodontic Clinic. 
iii. Describe any withholding of, delay in, or washout period for standard of care or 
alternative treatment that participants may be currently using: none 
 
d. Do you foresee that participants might need additional medical or psychological resources 
as a result of the research procedures/interventions?  
Yes 
No 
If Yes, describe the provisions that have been made to make these resources available.  
      
 
e. Do the benefits or knowledge to be gained outweigh the risks to participants?  
If No, provide justification for performing the research:       
Yes 
No 
 
19. Precautions/Minimization of Risks (If study involves drugs or devices complete the 
Drug or Device Review Sheet and skip to question #20) 
a. Describe precautions that will be taken to avoid risks and the means for monitoring to 
detect risks.  
 
Patient education and examination at regularly-scheduled follow-up visits 
• 
By signing the Informed Consent, parent or guardian agrees to be present at (and 
monitor) all device applications of their child. 
b. If hazards to an individual participant occur, describe (i) the criteria that will be used to 
decide whether that participant should be removed from the study; (ii) the procedure for 
removing such participants when necessary to protect their rights and welfare; and (iii) 

200 Clinpro™ -Protocol 
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Rev. 2/23/2011 
any special procedures, precautions, or follow-up that will be used to ensure the safety of 
other currently enrolled participants. 
All patients have the ability to stop using the product if adverse effects occur. This will be 
reported to PI who will stop the trial if necessary. 
c. If hazards occur that might make the risks of participation outweigh the benefits for all 
participants, describe (i) the criteria that will be used to stop or end the entire study and 
(ii) any special procedures, precautions, or follow-up that will be used to ensure the safety 
of currently enrolled participants.  
• 
Excessive whitening of teeth 
• 
Inflammation of tissues 
 
20. Informed Consent 
a. Do you plan to obtain informed consent for this protocol?  
Yes 
No 
If Yes, complete the items below. 
If No, complete and include the Waiver of Informed Consent or Waiver of Authorization 
and Informed Consent, as applicable.  
 
b. Do you plan to document informed consent for this protocol?  
Yes 
No 
If Yes, complete the items below. 
If No, complete the items below and include the Waiver of Informed Consent 
Documentation.  
 
c. How will consent be obtained? by interview 
 
d. Who will conduct the consent interview? PI or Research Coordinator 
 
e. Who are the persons who will provide consent or permission? patients or their parents 
 
f. What steps will be taken to minimize the possibility of coercion or undue influence? 
Patients will neither be encouraged nor discouraged to participate in the trial. 
 
g. What language will the prospective participant or the legally authorized representative 
understand? English only 
 
h. What language will be used to obtain consent? English only 
 
i. If any potential participants will be, or will have been, in a stressful, painful, or drugged 
condition before or during the consent process, describe the precautions proposed to 
overcome the effect of the condition on the consent process. If not, enter "no such effect." 
no such effect 
 
j. If any project-specific instruments will be used in the consenting process, such as flip 
charts or videos, describe the instrument(s) here, and provide a copy of each. If not, 
enter "not used." 
not used 
 
k. How long will participants have between the time they are told about the study and the 
time they must decide whether to enroll? If not 24 hours or more, describe the proposed 
time interval and why the 24-hour minimum is neither feasible nor practical. 30 minutes 
 
21. Procedures to Protect Privacy 
 
Describe the provisions included in the research to protect the privacy interests of 
participants (e.g., others will not overhear your conversation with potential participants, 
individuals will not be publicly identified or embarrassed). 

200 Clinpro™ -Protocol 
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Rev. 2/23/2011 
Patients will be interviewed in a private room away from other patients and staff members. 
 
22. Procedures to Maintain Confidentiality 
a. Describe the manner and method for storing research data and maintaining confidentiality. 
If data will be stored electronically anywhere other than a server maintained centrally by 
UAB, identify the departmental and all computer systems used to store protocol-related 
data, and describe how access to that data will be limited to those with a need to know.  
Paper patient records are stored in a locked file cabinet in a locked room. Electronic 
records are encrypted and password protected as required by standard UAB procedures. 
 
b. Will any information derived from this study be given to any person, including the subject, 
or any group, including coordinating centers and sponsors?  
Yes 
No  
 
If Yes, complete i-iii. 
 
i. To whom will the information be given?       
 
ii. What is the nature of the information?       
 
iii. How will the information be identified, coded, etc.?       
 
23. Additional Information 
In the space below, provide any additional information that you believe may help the IRB 
review the proposed research, or enter "None."  
None