American Association of Endodontists
American Association of Endodontists
Foundation
Request for Proposal
Release Date: November 2010
Submission Deadline Date: August 1, 2011
Earliest Award Date: Fall 2011
Purpose
The American Association of Endodontists (AAE) and the AAE Foundation (AAEF) will provide a
contract to support clinical research projects that will produce high-level evidence relating to regenerative
endodontic treatment. The research focus must be pertinent to various clinical aspects of regenerative
treatment. Examples include case selection, instruments and techniques, medication, and treatment
outcome. The research project design and methodology must adhere to stringent criteria consistent with
high levels of evidence. When appropriate, randomized controlled trials are strongly encouraged over
alternative designs. Multi-centered trials aimed at generating large sample size are also encouraged.
Background
The AAE is committed to incorporating regenerative procedures into the definition and scope of
endodontics. In addition, the AAE and AAEF are committed to the application of evidence based
methodology for endodontic education, research and practice. To promote these important concepts, in
2006 the AAE Board of Directors established the Regenerative Endodontics Committee (REC) as a regular
standing committee. In order to enhance and broaden the evidence for regenerative endodontic
procedures, the AAE and AAEF set out to solicit appropriate clinical research that will generate highlevel evidence to support endodontic practice that incorporates regenerative procedures. The AAE REC
and Research and Scientific Affairs Committee (RSAC) collaborated to develop several research questions
related to regenerative endodontics. After reviewing the questions, one clinical question was identified
as a priority for investigation.
Researchers have numerous options for study designs from a single researcher/institution to large
multicenter collaborations. Variables for potential designs are listed in the Statement of Research
Objectives below.
Eligibility Requirements
Proposals may be submitted by U.S. and Canadian for-profit and non-profit, public and private
organizations, such as universities, colleges, hospitals, laboratories, units of State/Province and local
governments, and eligible agencies of the Federal government, as well as foreign academic and scientific
institutions.
Mechanisms of Support
The mechanism of support will be a research contract between the AAE, AAEF and the principal
investigator’s institution. It is anticipated that this contract will take place over approximately six years.
Please contact the AAE or AAEF for additional contractual information.
Funds Availability
The estimated total funding (direct and indirect) available is in the range of $1.45-2.5 million paid over
approximately 6 years.
The AAE and AAEF intend to support or contribute to the support of the contract(s) ensuing from this
RFP beginning in 2011. Grant awards will be contingent on the receipt of high quality applications. The
AAE and AAEF reserve the right not to support any proposal, if none is considered to satisfy the purpose
of this RFP. For the successful proposal(s), funding beyond the first and subsequent years of the grant
will be contingent upon satisfactory progress during the preceding years and the availability of funds.
The following components should be included in a detailed budget:
 Database management
 Principal Investigator
 Endodontist plus dentist
 Statistician
 Dental assistant
 Research coordinator
 Treatment
 Patient remuneration
 Equipment (Requests must not duplicate any equipment in the principal investigator’s department
and must be justified and essential. All equipment purchased shall remain the property of the
institution. Equipment requests of $1,000 or more must include a signed statement from the
university to verify need and itemized price quotes. Requests for expendable supplies must be
justified and should not include supplies expected to be available from other sources.
 Training, calibration, monitoring
Research Objectives
The objective of the RFP is to solicit clinical research to answer the following clinical research question,
presented in PICO format:
Population:
Intervention:
Comparison:
Outcome:
In patients with pulpal necrosis,
does regenerative endodontic treatment,
compared to alternative treatment,
result in better outcomes?
Each of the four PICO components in this multi-factorial clinical research question comprises different
options that lend themselves to different combinations. Patient related variables should be constant. The
four PICO components include the following options:
1.
Endodontic Disease
1.1. Pulp necrosis
1.2. Apical abscess
1.3. Symptomatic or asymptomatic Apical Periodontitis
1.4. Potential for any of the above
2.
Endodontic Treatment (included in the categories below are variations in techniques, materials and clinical
strategies; each one of these variables can be the subject of a randomized controlled trial, while the others should
be controlled):
2.1. Initial (first-time) treatment
2.1.1. Number of treatment sessions
2.1.2. Irrigants – type, concentration
2.1.3. Intracanal medication – type, application period
2.1.4. Temporary seal/restoration
2.1.5. Operator’s level of training
2.2. Second Appointment
2.2.1. All of the above (2.1.1 – 2.1.5)
2.2.2. Source of stem cells
2.2.3. Scaffolds – Type
2.2.4.
2.2.5.
Growth factors – Type
Definitive restoration – Type, full coverage
3.
Alternative Treatment
3.1. Other endodontic treatment modality than the selected intervention
3.2. Variation of technique/material/strategy within the same intervention
3.3. Tooth extraction without replacement
3.4. Tooth replacement – fixed partial prosthesis, removable partial prosthesis, implant-supported
prosthesis
4.
Assessed Outcomes
4.1. Healing
4.1.1. Radiographic measures
4.1.2. Clinical measures
4.2. Function
4.2.1. True survival
4.2.2. Absence of untoward events
4.2.3. Absence of clinical signs and symptoms
4.3. Quality of life and satisfaction perceptions, as they pertain to all aspects of endodontic disease,
treatment and function of diseased/treated teeth. These outcomes may include economic,
esthetic, physiologic and physical aspects, such as the quality of sensation of chewing
4.4. Patient-defined utilities
4.5. Economical
4.6. Observation period
4.6.1. 1 year
4.6.2. 2 years
4.6.3. 3 years
4.6.4. 4 years
4.6.5. 5 years
Outcome Measures and Assessment Criteria
Standardized and validated outcome measures and assessment criteria must be used for the selected
outcome assessment category. When appropriate, outcome assessment must observe strict rules of
calibration and blinding. Outcome assessment should minimally occur on an annual basis for a four to
five year period.
For assessment of pulpal and perioapical healing and function, the following outcome definitions
approved by the AAE and AAEF are recommended, however, researchers are invited to provide
additional clarification of terms:
1. Healed with tissue regeneration— Functional*, asymptomatic teeth with no or minimal radiographic
periradicular pathosis. Radiographic evidence of new dentin/mineral tissue formation in the coronal
and/or radicular portion.
2. Healed without tissue regeneration -- Functional*, asymptomatic teeth with no or minimal
radiographic periradicular pathosis. No radiographic evidence of new dentin/mineral tissue
formation in the coronal and/or radicular portion.
3. Non-healed—Nonfunctional, symptomatic teeth with or without radiographic periradicular pathosis.
* Functional—A treated tooth or root that is serving its intended purpose in the dentition.
Proposal Procedures
The proposal will consist of the following elements:
1.
2.
Application (ATTACHMENT A)
Abstract of proposed study. (limit to 300 words).
3.
Budget
A. First year budget: provide individual components as listed on page 2 of this RFP, “Funds
Availability,” as well as indirect costs.
B. Total granting period: provide individual components as listed on page 2 of this RFP, “Funds
Availability,” as well as indirect costs.
C. Detailed justification of the proposed budget.
D. Source(s) for other requested funding.
4.
Biographical sketches of all key personnel (4 page limit per person) with identification of the primary
investigator. If this is a multi-center project, each center should have a primary contact listed along
with a biographical sketch. The relevant experience and training of the key personnel in conducting
similar studies should be highlighted in the biographical sketch and reprints of their relevant
publications should be included in the Appendix.
5.
6.
Research proposal should be no longer than 20 pages formatted in 12 pt font with one inch margins
A. Specific aims.
B. Background of question being studied and significance to endodontics/dentistry (2 page
limit).
C. Preliminary data. Investigators with prior experience in conducting similar studies are
encouraged to present their data in order to support their ability to conduct a comprehensive
and scientifically valid clinical investigation that includes a standardized and validated
outcome measure of clinical success.
D. Approach. This section should provide complete information necessary to evaluate the
experimental approach. Methods of ascertaining the security and longevity of data should be
outlined. Statistical methods should include sample size calculations, estimates of power, and
a detailed plan for analyses. Use this section to justify your experimental methods and
standardized outcome measures. It is expected that an appropriate data safety management
board (DMSB) will be involved. Drugs to be used have to be FDA-approved; the use of
investigational or new drugs (IND) has to cleared by the appropriate process.
E. Time-line for research. Research milestones should be provided with 6-month intervals and
are required as a basis for periodic contract performance review.
F. Letter of approval from relevant Institutional Review Board (IRB) panels and the informed
consent and subject enrollment documents for patient recruitment and safety monitoring.
References
Appendix. Include reprints of relevant publications by the key personnel of the proposal.
Proposals must be sent on a CD in PDF format to the address below. Documents sent via email will not
be accepted. Sign the application form, which can be scanned and included with your proposal as a TIFF
or JPEG image file.
Chair, AAE Research & Scientific Affairs Committee
c/o Assistant Executive Director for Development
American Association of Endodontists
211 E. Chicago Ave., Suite 1100
Chicago, IL 60611-2691
drice@aae.org
Proposals must be received by August 1, 2011. If a proposal is received after that date, it will be returned
without review.
Review Considerations
Upon receipt, proposals will be reviewed by the AAE Research and Scientific Affairs Committee, for
completeness and responsiveness to this RFP. Incomplete and/or non-responsive proposals will be
returned to the applicant without further consideration. If the committee deems it appropriate, special
experts such as statisticians, clinical trial researchers or other types of scientists may included in the
review process. The consultants’ comments are reviewed and forwarded to a special oversight committee
composed of the presidents of the AAE and the AAE Foundation, the Chair of the Research and Scientific
Affairs Committee and a representative from the Regenerative Endodontics Committee and the JOE
editorial Board. The Research and Scientific Affairs Committee will review the consultants’
recommendations and any comments from the oversight committee and recommend a grantee/s to the
AAE Foundation Board of Trustees. The reviewers will use the revised NIH scoring system (1-9 with 1
being outstanding) with written critiques and the NIH criteria to evaluate the proposals. All proposals
will receive a written critique and undergo full committee review.
Review Criteria
The reviewers will evaluate the applications in the following areas in order to determine the scientific and
clinical merits for possible funding.
SIGNIFICANCE: Is the study addressing important problem or questions in endodontics? Are the Aims
of the study responsive to the RFP? At the conclusion of the study, what will be the benefit to the
scientific, academic, and public communities in terms of their endodontic needs? Is the outcome of the
study going to change the direction of the field in endodontics?
APPROACH: Is the conceptual framework of the study sound? Are the appropriate methodologies
proposed? Are the proposed approaches feasible? Is the feasibility demonstrated in the literature or
preliminary data? Does the applicant address the potential pitfalls and alternative approaches?
INNOVATION: Does the study involve new ideas, techniques, assay development, or approaches? Does
the study have potential for broader impact to shift the paradigm in endodontics?
INVESTIGATOR: Are the investigators well trained and qualified to undertake the study? Does the
publication track record support the investigators’ productivity? Do the investigators demonstrate a
funding record that would help continue the project above and beyond the current RFP?
ENVIRONMENT: Do the scientific environment and institution support the proposed study? Does the
institution provide a scientific environment conducive for the success of the proposed study? Is there any
aspect of the environment uniquely suited for the proposed study and if so what is the evidence?
Award Criteria
The earliest anticipated date of award is July 1, 2011. Applicants should be aware that, in addition to
scientific merit, the total cost of the proposed project and the availability of funds will be considered by
the AAE and AAEF in making funding decisions. In addition, the AAE and AAEF value complementary
funding from other public and private sources, including foundations, corporate partners, and the
applicant’s institution. In circumstances in which proposals have similar scientific merit, but vary in costcompetitiveness, the AAE and AAEF are likely to select the more cost-competitive proposal for funding.
Manuscripts based on research supported by the AAE Foundation must be submitted first to the Journal
of Endodontics. The following statement must be included in any written or oral presentation of research
supported by the AAE Foundation: This research was supported in part by a grant from the American
Association of Endodontists Foundation.
Reporting
An outcomes assessment report should be provided annually, including any abstracts, poster
presentations, or manuscripts. Continued funding will be contingent on the submission of an annual
progress report. The report must contain the following information:
 Actual and projected budget


Overall status of the project including the cohort study (number of subjects enrolled, completed,
withdrawn or dropped out)
List of publications including abstracts, poster presentations or manuscripts
The report will be reviewed by the Research and Scientific Affairs Committee. Their recommendations for
continued funding will be reviewed by the Foundation’s Board of Trustees.
In addition, the status of the study cohort (number of subjects enrolled, completed, withdrawn and
dropped out) should be reported annually. Annual budget reports should specify actual expenditure to
date. Researchers are required to make their raw data available to the AAE after publication or within 5
years following the end of funding for this project.
Inquires
Written, e-mail and telephone inquiries are encouraged. The opportunity to clarify any issues or
questions from potential applicants is welcome.
Direct inquiries regarding programmatic issues to:
Chair, AAE Research & Scientific Affairs Committee
c/o Assistant Executive Director for Development
American Association of Endodontists
211 E. Chicago Ave., Suite 1100
Chicago, IL 60611-2691
Phone: 312/266-7255 or 800/872-3636, ext. 3017
Fax: 312/266-9867 or 866/451-9020
E-mail: drice@aae.org
8/26/10
ATTACHMENT A
American Association of Endodontists
American Association of Endodontists Foundation
REQUEST FOR PROPOSAL APPLICATION
Please type directly in the shaded areas. The box will expand as you type. Use the tab key to move
from box to box. This form requires your signature. Please scan the signed form and include it with
your proposal as a PDF file.
Title of proposed investigation/project
Principal investigator/program director
Name
Institution
Position Title
Department or Equivalent
Address
City
State/Province
Zip/Postal Code
Phone
Fax
E-mail
Professional degrees/certificates, institutions conferring them, dates
Animal/Human use committee approvals
Enclosed
Applied For (documentation enclosed)
Dates of proposed period of support
Budget
Costs for initial budget period (direct and indirect costs)
Costs for proposed period of support (direct and indirect costs)
Has other funding been received or applied for?
Yes
No
If so, amount $
Not applicable
Location/s where research will be conducted
Official signing application or organization
Name
Institution
Position Title
Department or Equivalent
Address
City
State/Province
Zip/Postal Code
Phone
Fax
E-mail
Principal Investigator/Program Director Assurance: I certify that the statements herein are true,
complete and accurate to the best of my knowledge. I am aware that any false, fictitious, or fraudulent
statements or claims may subject me to criminal, civil, to administrative penalties. I agree to accept
responsibility for the scientific conduct of the project and to provide the required progress reports if a
grant is awarded as a result of this application.
________________________________________________________________________
Signature of principal investigator/program director
Applicant Organization Certificate of Acceptance: I certify that the statements herein are true, complete
and accurate to the best of my knowledge. I am aware that any false, fictitious, or fraudulent statements
or claims may subject me to criminal, civil, to administrative penalties.
________________________________________________________________________
Signature of official signing for organization
Send this form and your proposal to
Chair, AAE Research & Scientific Affairs Committee
c/o Assistant Executive Director for Development
American Association of Endodontists
211 E. Chicago Ave., Suite 1100
Chicago, IL 60611-2691
drice@aae.org
6-15-06