UNMC College of Dentistry Researchers Receive More Than $2 Million to Study Effect of Drug on Preventing, Treating Oral Bone Loss

University of Nebraska Medical Center College of Dentistry researcher

and dentist, Jeffrey B. Payne, D.D.S., has seen many elderly women patients

suffer the loss of teeth because of periodontitis a disease that causes

destruction of bone and gums, the supporting structures of the teeth. Periodontitis

is the number one cause of tooth loss in men and women in the United States.

With the help of a five-year, $2.09 million clinical trial grant from

the National Institutes of Health, National Institute of Dental and Craniofacial

Research, Dr. Payne and other researchers will evaluate the effectiveness

of Dr. Payne and other researchers will evaluate the effectiveness of a

drug called Periostat in reducing oral bone loss and improving bone density

in the hip and spine of women.  Researchers know periodontitis results

in collagen being broken down, ultimately destroying bone.

Women are concerned about losing teeth, said Dr. Payne, UNMC assistant

dean for research and F. Gene and Rosemary Dixon Endowed Chair in Dentistry.

They are extremely health conscious. In general, if patients lose teeth,

they want to replace them because of lost function and for aesthetic reasons.

Once a tooth is lost, other teeth start drifting. This compromises chewing

function and a patients quality of life.

Periodontitis, which results in the loss of bone supporting teeth in

the jaws, affects about 36 percent of U.S. adults, Dr. Payne said.

Periostatâ was approved by the FDA in September 1998 and is the

first and only oral drug approved as an additional treatment for periodontitis. 

The drug helps prevent the breakdown of collagen, a major structural protein

of the body that is found in bone, skin, gum tissues, ligaments and cartilage.

Before the drug was approved, periodontitis was treated primarily through

teeth cleaning and surgery.

The critical destructive phase in periodontitis is the destruction

of collagen. If you can inhibit that process, then you can inhibit bone

loss and perhaps even enhance bone gain, said Dr. Payne, principal investigator

for the grant.  If our hypothesis proves correct, Periostatâ

could be used to prevent the loss of bone and gum support in the mouth,

thus reducing tooth loss, said Dr. Payne, principal investigator of the

study.

Researchers at UNMC and the State University of New York at Stony Brook

School of Dental Medicine will test the effectiveness of Periostatâ

in 120 post-menopausal women, ages 45 to 70 years old, who have periodontitis

and osteopenia. Osteopenia is reduced bone mass in the body and represents

an early stage of osteoporosis.

Osteoporosis, or porous bone, is a disease characterized by low bone

mass and structural deterioration of bone tissue, leading to bone fragility

and an increased susceptibility to fractures of the hip, spine, and wrist.

It is a major public health threat for more than 28 million Americans,

80 percent of whom are women. In the U.S. today, 10 million individuals

already have osteoporosis and 18 million more have low bone mass, placing

them at increased risk for the disease.

In the double-blind study, which means neither researchers nor the participants

will know who received the drug and who received the placebo, women eligible

for the study will receive free screenings, tests, Periostatâ and

a daily dose of 1,200 milligrams of calcium and 400 international units

of vitamin D. Tests, including intraoral X-rays and dual energy X-ray absorptiometry

(DEXA) scans, will be given at the beginning of the study and at one and

two years. A DEXA scan is a fast, simple X-ray that evaluates the density

of the hip and spine to confirm osteopenia or osteoporosis.  Art Weaver,

M.D., of the Arthritis Center of Nebraska, who also is a UNMC clinical

professor of internal medicine, will work with UNMC College of Dentistry

researchers on DEXA data generated from this study.

Women will continue to see their periodontists during the study.

In addition to oral bone loss, researchers will also look at the drugs

potential to treat osteopenia.

Dr. Payne said, If you can treat or inhibit oral bone loss, it would

be beneficial at the same time to reduce systemic bone loss. Another important

issue in studying oral bone loss is the compelling scientific evidence

emerging about the relationship between the health of the mouth and the

systemic health of the body.

Last year, the United States Surgeon General, in its first report ever

on oral health, addressed the importance of oral health in maintaining

systemic, or overall, health.

There is more scientific evidence emerging that tells us if a person

doesnt maintain a healthy oral environment, that could place them at risk

for other systemic diseases, Dr. Payne said.  We also know that

systemic diseases such as uncontrolled diabetes and osteoporosis place

individuals at greater risk for tooth loss.

Our hypothesis is that this drug will reduce oral bone loss and enhance

bone gain, but we also want to know if it will inhibit bone loss in the

body — specifically in the hip and lumbar spine of post-menopausal women.

If this drug has a positive effect on the hip and spine, it will lead to

another larger study to look at this systemic outcome.  Periostatâ

could potentially be a very inexpensive, safe therapy for osteopenia and

osteoporosis.

The outcomes of this study could very well lead to a lot of new areas 

of research, which was what the NIH review team was very excited about.

 For more information about enrolling in the study, call Julie

Layton, (402) 472-9852. The UNMC College of Dentistry is located in Lincoln.