Statement of Work for Dr. Sema Cinar

1.  [Objectives]{.underline}

The contractor will work with Dr. Thomas Hart and other members of the
Human and Craniofacial Genetics Section. The contractor will perform
recruitment and clinical assessment of individuals from families
segregating amelogenesis imperfecta (AI) and Aggressive Periodontitis
(AP) and drug induced gingival overgrowth (DIGO). Dr. Cinar's work will
focus on identification of families segregating these genetic
conditions, diagnosing which family members are and which are not
affected, obtaining informed consent from individuals to participate in
studies to identify the underlying genetic basis of disease in their
families and understanding the mechanism of this disease. The areas of
the investigation include ascertainment of affected AI and AP probands
and their family members, determination of who does and who does not
have the disease, obtaining appropriate samples for DNA isolation
including peripheral blood, buccal swabs or oral rinses. She will also
identify and collect samples from individuals with DIGO, but not their
family members. Isolated DNA will be used to perform genotyping and
sequencing analyses of candidate genetic intervals and genes. These
studies are aimed at characterization of the underlying gene defect in
each family and in determining how the mutations act to cause disease.

2.  [Approach]{.underline}

The contractor will be involved in implementing clinical ascertainment
of individuals with AI, AP and DIGO. The contractor will be involved in
ascertaining family members of individuals with AI and AP, and
diagnosing affected status. The Contractor will be involved with tissue
procurement and treatment of affected individuals in her clinic. The
contractor will be responsible for preparation of samples and shipment
to the Human and Craniofacial Genetics laboratory for analysis. The
contractor will work with personnel from the Human and Craniofacial
Genetics section in preparation of reports including scientific
manuscript describing findings of molecular genetic studies.

3.  [Methods]{.underline}

The services will be performed as follows:

a)  The contractor will participate in ongoing research related to
    identification of the genetic basis of Aggressive Periodontitis and
    Amelogenesis Imperfecta and characterization of the functional
    defect that causes these diseases. Specifically the contractor will
    ascertain individuals affected by AI, AP and DIGO, including
    clinical diagnosis, collection of specimens and preparation of
    specimens for DNA extraction, cell culture and immunohistochemistry.

b)  The contractor must have expertise in clinical diagnosis of various
    forms of Amelogenesis Imperfecta, Aggressive Periodontitis and drug
    indiced gingival overgrowth and the ability to distinguish the
    condition from sporadic phenocopies of the condition. The contractor
    must have a background in genetics, and have the ability to record
    accurate pedigrees.

c)  The contractor will have expertise to inform the affected
    individuals of the appropriate treatment of AP associated
    periodontitis, DIGO and provide periodontal treatment if the patient
    elects.

d)  The contractor will have expertise to perform standard biopsies of
    gingival tissues.

e)  The contractor will have expertise to perform standard radiography
    of AP, AI and DIGO affected sites.

f)  The contractor will maintain clear and accurate records relating to
    clinical information as well as tracking samples.

g)  The contractor should have excellent oral communication skills and
    be able to participate in writing scientific reports as well as
    clinical records.

    [Personnel, evaluation and schedule]{.underline}

    [A. Personnel]{.underline}

The contractor must have a working knowledge of general dentistry and
expertise in Periodontology. The contractor must have a working
knowledge of genetics including modes of transmission of Mendelian
diseases. The contractor must have expertise in the various forms of
periodontitis and enamel defects. The contractor will be skilled in
sample preparation for DNA isolation and for transport of tissue
samples. Personnel provided under the contract will comply with the
rules and policies of the NIDCR and its staff.

[B. Evaluation]{.underline}

The contractor is expected to work in an independent self-motivated
fashion. The contractor is expected to work closely with the Section
Chief and other members of the laboratory and will be evaluated at least
once a week by discussing a weekly progress report with the section
chief. If the contractor is considered to be substandard in the judgment
of the section chief, the contractor will initially receive notice of
the problem from the section chief and will be required to take
corrective measures and to demonstrate improved performance.

[C. Schedule]{.underline}

The contractor will perform duties related to the study for a minimum of
15 hours a week. The contractor will have flexibility to determine the
days the work is performed, as this will be dictated in large measure by
subject availability and study subjects availability. Failure to
schedule and perform the necessary duties shall be considered default of
the contract.

[D. Reporting Requirements]{.underline}

The contractor shall provide professional services for the Human and
Craniofacial Genetics Section, NIDCR during the period of April 23, 2007
to March 24, 2008. The contractor will be paid a total of \$15,000 for
this 12 month period.

**[Justification]{.underline}**

Attached is a request for \$15,000 to provide per Diem and travel for
the services of Dr. Sema Cinar. Under this contract, Dr. Cinar will
provide clinical research services to the Human and Craniofacial
Genetics Section, NIDCR. Her contract will run from April 23, 2007 to
March 24, 2008. The work requires specialized clinical skills and basic
research skills for sample preparation. Dr. Cinar is a dentist with
specialized training in the field of Periodontology. She is also
experienced in understanding of human genetics related to aggressive
periodontitis, amelogenesis imperfecta, drug induced gingival overgrowth
and has published scientific manuscripts related to these topics. The
procedures described need technical skill and expertise in the area of
normal and abnormal periodontal development. She is also proficient with
the methods related to establishing the needed database and recording
the appropriate information.

Additionally, Dr. Cinar has the expertise and self motivation to
successfully perform the project. She is familiar with all goals of the
proposal, and understands when to support different aspects of the
project to ensure successful completion. Her specific expertise in the
area of genetics of Periodontology and dental development research makes
her an ideal candidate for this work.

**[Task Description]{.underline}**

Firm will issue 12 checks on the following days for the following
amounts:

April 23, 2007 for \$1,250.00

May 21, 2007 for \$1,250.00

June 25, 2007 for \$1,250.00

July 23, 2007 for \$1,250.00

August 20, 2007 for \$1,250.00

September 24, 2007 for \$1,250.00

October 22, 2007 for \$1,250.00

November 26, 2007 for \$1,250.00

December 17, 2007 for \$1,250.00

January 22, 2008 for \$1,250.00

February 25, 2008 for \$1,250.00

March 24, 2008 for \$1,250.00

**Mailing Address**

Dr. Thomas C. Hart

National Institutes of Health

10 Center Drive, MSC 1470

Building 10, Room 5-2531

Bethesda, MD 20892-1470