Obstetrics and Periodontal Therapy (opt) Study Manual of Operations Version 1 March 3, 2003 Brief Table of Contents



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Randomization Phone Number: 1-800-353-8636

Division of Biostatistics

School of Public Health

2221 University Ave SE, Suite 200

Minneapolis, Minnesota 55414
Jim Hodges, PhD, Director

Phone: 612-626-9626

Fax: 612-626-8892

Email: hodges@ccbr.umn.edu 


Sandi Wewerka, Statistical Study Manager

Phone: 612.624.8321

Pager: 612.510.6119

Fax: 612.625.0080

Email: sandiw@ccbr.umn.edu
Helen Voelker, Database Administrator

Phone: 612-626-9016

Fax: 612-625.0080

Email: helen@ccbr.umn.edu


Irene Olson, Data Entry/Quality Control Operator

Phone: 612-626-9018

Fax: 612-625-0080

Email: irene@ccbr.umn.edu


Kathy Farnell, Forms Designer

Phone: 612-626-9013

Fax: 612-625-0080

Email: kathy@ccbr.umn.edu


Yi He, Graduate Research Assistant

Phone: 612.626.8332

Fax: 612.625.0080

Email: yihe@biostat.umn.edu



Hennepin County Medical Center (Minneapolis)
Enrollment Site Principal Investigator

Anthony J. DiAngelis, DMD

Chief of Dentistry

Hennepin County Medical Center

701 Park Avenue

Department of Dentistry

4th Floor North Block

Minneapolis, MN 55415

Phone: 612-347-2382

Fax: 612-904-4234  

E-mail Address: anthony.diangelis@co.hennepin.mn.us
Obstetrical Investigator

Virginia Lupo, MD

Chair, Department of Obstetrics and Gynecology

Hennepin County Medical Center

701 Park Avenue

3rd Floor, South Block

Minneapolis, MN 55415

Phone: 612-347-2750

Fax: 612-904-4274

Email: virginia.lupo@co.hennepin.mn.us


Treatment-Blinded Consulting Periodontist

Larry Wolff, PhD, DDS

Department of Preventive Sciences

School of Dentistry

17-164 Moos Tower

515 Delaware St. SE

Minneapolis, MN 55455

Phone: 612-625-5681

Email: wolff001@umn.edu

General Dentist

James R. Gambucci, D.D.S., M.P.H.

15-136 Moos Health Sciences Tower

515 Delaware Street S.E.

Minneapolis, MN 55455

Phone: 612.625.6950

E-Mail: gambu001@umn.edu



Study Coordinator

Leslie Long-Simpson

Hennepin County Medical Center

701 Park Avenue

Department of Dentistry

4th Floor North Block, MC 814

Minneapolis, MN 55415

Phone: 612-347-6862

Pager: 612-510-5046

Fax: 612-904-4234

E Mail: leslie.long-simpson@co.hennepin.mn.us



Treatment Hygienist

Kelly Meyer, RDH

Hennepin County Medical Center

701 Park Avenue

Department of Dentistry

4th Floor North Block

Minneapolis, MN 55415

Phone: 612.347.6862 (temporary)

Fax: 612.904.4234


On-Site Recruitment Coordinator

Jeanne Anderson

Hennepin County Medical Center

701 Park Avenue

Department of Dentistry

4th Floor North Block

Minneapolis, MN 55417

Phone: 612-347-6862

Fax: 612-904-4234

Treatment Blinded Calibrated Periodontal Examiners

Joy Osborn

Hennepin County Medical Center

701 Park Avenue

Department of Dentistry

4th Floor North Block

Minneapolis, MN 55417

Phone: 612-625-8970

E-Mail: osbor001@umn.edu


Jill Stoltenberg

Hennepin County Medical Center

701 Park Avenue

Department of Dentistry

4th Floor North Block

Minneapolis, MN 55417

Phone: 612-625-5651

E-Mail: stolt001@umn.edu



Dental Assistant

Traci Thompson

Hennepin County Medical Center

701 Park Avenue

Department of Dentistry

4th Floor North Block

Minneapolis, MN 55417

Phone: 612.347.6862


EDC Scheduler

Janet Campanaro

15-136 Moos Health Sciences Tower

515 Delaware Street S.E.

Minneapolis, MN 55455

Phone: 612.625.6950

E-Mail: j-camp@umn.edu



Nurse Abstractor

Susan Lovett

701 Park Avenue

Medical Specialty Building

Labor & Delivery

Minneapolis, MN 55415

Phone: 612.347-4104

Fax: 612-904-4274

E-Mail: susan.lovett@co.hennepin.mn.us


University of Mississippi
Enrollment Site Principal Investigator

William Buchanan, D.D.S., M.Md.Sc.

Department of Periodontics

University of Mississippi School of Dentistry

2500 North State St.

Jackson, MS 39216

Phone: 601-984-6118

Fax: 601-984-6120

Cell: 601-594-6551

Email: wibuchanan@sod.umsmed.edu

Residence phone: 601-919-3550
Secretary: Betty Thompson

Phone: 601-984-6115


Obstetrical Investigator

James Bofill, M.D.

Obstetrics and Gynecology

School of Medicine

University of Mississippi Medical Center

2500 North State St.

Jackson, MS 39216

Phone: 601-815-7036 (OB-GYN Diagnostic Unit); or 601-984-5300

Pager: 601-973-4919

Fax: 601-984-6773

Email: jbofill@jam.rr.com
Secretary: Robema Carter

Phone: 601-984-5327

E-mail: rcarter@ob-gyn.umsmed.edu
Periodontal Investigator

Roger B. Johnson, DDS, PhD

Department of Periodontics

University of Mississippi School of Dentistry

2500 N. State Street

Jackson, MS 39216-4505

Phone: 601-815-3791 or 601-984-6115

Fax: 601-984-6120

E-mail: rjohnson@sod.umsmed.edu
Study Coordinator

Stacy Hull-Vance, BS, MS

The ACT Center

Jackson Medical Mall, Suite 310

350 West Woodrow Wilson

Jackson, MS 39213

Phone: 601-815-7062

E-mail: svance@sod.umsmed.edu



Recruitment and Treatment Hygienist

Angelia Garner, R.D.H.

The ACT Center

Jackson Medical Mall, Suite 310

350 West Woodrow Wilson

Jackson, MS 39213

Calibrated Periodontal Examiner

Robin Howard

The ACT Center

Jackson Medical Mall, Suite 310

350 West Woodrow Wilson

Jackson, MS 39213

General Dentist

Lon DeMoss, D.M.D.

Dental Clinic

Jackson Medical Mall, Suite 310

350 West Woodrow Wilson

Jackson, MS 39213

Phone: 601.984.6028

E-Mail: ldemoss@sod.umsmed.edu

University of Kentucky
Enrollment Site Principal Investigator

M. John Novak, BDS, LDS, MS, PhD

Professor of Periodontics, Associate Director

Center for Oral Health Research

College of Dentistry

D540 Dental Science Building

University of Kentucky

Lexington, KY 40536-0297

Phone: 859-323-5159

Fax: 859-257-6566

email: mjnova2@pop.uky.edu
Obstetrical Investigator:

James E. Ferguson, II, MD

John Greene Professor and Chair

Department of Obstetrics and Gynecology

University of Kentucky

College of Medicine

Room C375, UKMC

800 Rose Street

Lexington, KY 40536-0293

Phone: 859-323-6434

Fax: 859-323-1931

Email: jef@uky.edu


Periodontal Investigator/Calibrated Periodontal Examiner:

Dolph Dawson, MS, DMD

Center for Oral Health Research

University of Kentucky College of Dentistry

D-542 Dental Sciences Building

Lexington, Kentucky 40536-0297

Phone: 859-323-4735

Fax: 859-257-6566

E-mail: drdaws0@uky.edu
Study Coordinator:

Dawn G. Dawson RDH

Center for Oral Health Research

University of Kentucky College of Dentistry

D- 542 Dental Sciences Building

Lexington, Kentucky 40536-0297

Phone: 859-323-4923

Fax: 859-527-6566

E-mail: ddaws1@uky.edu

Treatment Hygienist

Amelia Buell, RDH

Center for Oral Health Research

University of Kentucky College of Dentistry

D-542 Dental Sciences Building

Lexington, Kentucky 40536-0297

Phone: 859-323-4923

Fax: 859-257-6566

E Mail: abuel2@email.uky.edu


Host Response Laboratory:
Jeffrey L. Ebersole, Ph.D, Director

Director, Center for Oral Health Research

College of Dentistry

D544 Chandler Medical Center

University of Kentucky

Lexington, KY 40536-0297

Phone: 859-323-5357

Fax: 859-257-6566

Email: jleber2@pop.uky.edu


Columbia University/Harlem Hospital
Enrollment Site Principal Investigator

Panos N. Papapanou, DDS, PhD

Director, Division of Periodontics

School of Dental and Oral Surgery

630 West 168th Street, PH-7E-110

New York, NY 10032

Phone: 212-305-9289

Fax: 212-305-9313

E-mail: pp192@columbia.edu
Periodontal Investigator

Dennis A. Mitchell-Lewis, DDS, MPH

Division of Periodontics

School of Dental & Oral Surgery

630 West 168th Street

P&S Box 20

New York, N.Y. 10032

Phone: 212-304-7171

Fax: 212-304-7174

E-mail: dml48@columbia.edu


Obstetrical Investigator

Stephen Matseoane, MD

Director OB/GYN

Harlem Hospital Center

MLK 4169 A

506 Lenox Avenue

New York, New York 10037

Phone: 212-939-4335

Fax: 212-939-4344

E-mail: bl2@columbia.edu


Study Coordinator

Giselle Santivanez

Harlem Hospital Center

Ronald H. Brown Building

530 Lenox Avenue 137th Street

Room 2083

New York, NY 10037

212-939-8269

E-mail: gs640@columbia.edu


Treatment Hygienist
Donna Campillo, B.S., R.D.H.

Harlem Hospital Center

Ronald H. Brown Building

530 Lenox Avenue 137th Street

Room 2083

New York, NY 10037

212-939-8269

E-mail: dcamp77@aol.com

Treatment Blinded Calibrated Periodontal Examiner

Elizabeth Mendez, RDH

Harlem Hospital Center

Ronald H. Brown Building

530 Lenox Avenue 137th Street

Room 2083

New York, NY 10037

212-939-8269

E-Mail: em490@columbia.edu
On Site Recruitment Coordinator/Dental Assistant

Joann Mays

Harlem Hospital Center

Ronald H. Brown Building

530 Lenox Avenue 137th Street

Room 2083

New York, NY 10037

212-939-8269

E-Mail: jm852@columbia.edu

National Institute of Dental and Craniofacial Research
Richard L. Mowery, Ph.D.

Chief, Clinical, Epidemiology, and Behavioral Research Branch

Division of Population and Health Promotion Sciences

National Institute of Dental and Craniofacial Research

Bldg. 45, Room 4As.43F

45 Center Dr., MSC 6401

Bethesda, MD 20892-6401

Tel: 301-594-4841

Fax: 301-480-8322

e-mail: rm33a@nih.gov


Consultants
Shelley Springer, MD (neonatology)

121 Hill Circle West

Big Lake, MN  55309

Phone: 763-263-0460

Fax: 763-262-6688

Email: scspringer@mindspring.com


John E. Connett, PhD (clinical trials)

Chair, Division of Biostatistics

School of Public Health

2221 University Ave SE, Suite 200

Minneapolis, Minnesota 55414

Phone: 612-626-9010

Fax: 612-625-0080

Email: john-c@ccbr.umn.edu



3. Schedule of Visits and Evaluations
The following page gives a schedule of visits and evaluations in the form of a table, in which rows represent evaluations or forms, while columns represent visits.
For those who prefer this information in the form of a list of events, Form 05 (Subject Event Checklist) is such a list. See Section V, Case Report Forms.




Data collected, or Event

Recruit-ment

Visit 1 Baseline/

Random-ization



Before

20 weeks GA



Visit 2

V1 + 4 wk



Visit 3

V2 + 4 wk



Visit 4

V3 + 4 wk



Visit 5

V4 + 4 wk



Visit 6

V5 + 4 wk



After

Delivery


Informed Consent

X

























Enrollment (Forms 01, 02, 03)

X

























Baseline Obstetric Data (Form 10)

X

























Baseline Oral Exam




X






















Perio Measurements (Form 11)




X







X




X







Medications (Form 12)




X




X

X

X

X

X




Plaque sample




X













X







Serum sample




X













X







Essential Dental Care (Form 20)







X



















Periodontal Therapy







Test group (Form 21)
















Cntrl group (Form 22)

Confirmation of Visit/Missed Visit (Form 23)










X

X

X

X

X




Brief Oral Exam










Control group

Control group

Control group

Control group

Control group




Supragingival Polish & OHI










Test group

Test group

Test group

Test group

Test group




Perio Adverse Event (Form 40)










as needed

as needed

as needed

as needed

as needed




Delivery Data/Pregnancy Adverse Event (Form 60), Neonatal Outcome (Form 61)










as needed

as needed

as needed

as needed

as needed

X

Serious Adverse Event (Form 41)










as needed

as needed

as needed

as needed

as needed

as needed
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