Dental research: the clinical trial formula
Article Abstract:
Dr. Michael Buonocore, the late director of dental research at the Eastman Dental Center in Rochester, New York, was regarded as a fine scientist as well as an innovator in his field. He is best known for developing the acid-etching technique of applying sealants and for designing restorative materials. An essential aspect of the outcome of his designs was the clinical trial procedure; new approaches must go through clinical trials before dental practitioners can use them. A history and evaluation of dental clinical trials are provided. Beginning in the 1940s, study methods improved steadily, with increasing awareness of the importance of controls (untreated counterparts of experimental subjects), elimination of bias, and double-blinding (keeping experimental personnel and subjects uninformed about which subjects are in control or experimental groups). Details on the development of sealants are provided. When initial clinical trials of sealants seemed promising, it was time to evaluate various compounds. Two types of compounds were chosen and studied in trials lasting seven years. Each of 382 children served as his/her own control by being observed at two different times. Selection of appropriate subjects has been another problem for dental researchers. Early case studies of single subjects, reported as anecdotes, gave way to rigorously designed experiments. Interpretation of such experiments, though, should not go beyond reasonable limits: researchers must know when their results can be extrapolated beyond a small experimental group. Final data analysis depends on an understanding of statistics, and even then, statistical significance may not be the same as clinical relevance. Dental clinical research today is expensive, and product manufacturers perform as many animal studies as possible before presenting an item for clinical trials. Furthermore, new products are classified by the Food and Drug Administration (FDA) as Class I, II, or III, depending on their potential health hazards. Less safe products, logically enough, face a more rigorous screening. On the whole, recommendations made by the Council on Dental Therapeutics are accepted by the FDA. The Princeton Dental Resource Center, founded in 1987, is a nonprofit independent organization linking dentists and scientists. One of its goals is to help new research ideas win faster acceptance by practitioners. Such approaches become increasingly relevant as the dental health of Americans continues to improve. (Consumer Summary produced by Reliance Medical Information, Inc.)
Publication Name: Journal of the American Dental Association
Subject: Health
ISSN: 0002-8177
Year: 1990
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Evaluating a behavioral method to manage dental fear: a 2-year study of dental practices
Article Abstract:
Fear of going to the dentist is very common; 70 percent of Americans admit to some degree of fear, while 20 percent experience extreme fear of dental procedures. This anxiety causes many people to avoid the dentist altogether, while others make appointments and then cancel them. Unfortunately, a minor dental problem may become an emergency because of such procrastination. Fearful patients are not only very uncomfortable themselves, they generate much stress for the dentist and office staff because their behavior can be difficult to manage. A program designed to treat dental fear is described. Eleven private dental offices and a university clinic offered the program to individuals who experienced fear of going to the dentist. During a period of 15 months, 111 people went through the program. Their ages ranged from 11 to 68 years, and the average time since they had last seen a dentist was four years. First, they filled out questionnaires designed to measure the severity and nature of their fears and talked with a staff member about their responses. They watched a videotape of a dentist performing a procedure on a fearful patient; the patient was able to stop the procedure and the dentist was gentle and reassuring. The participants were trained in two relaxation techniques and were given audiotapes so they could practice at home. Finally, the staff member used a technique called systematic desensitization and described scenes leading up to the dental procedure while the participants used relaxation techniques to reduce their fearful reactions. The program was effective in decreasing strong dental fears, since 77 percent of the people subsequently went through with substantial dental treatments and said that at least some parts of the program were helpful in reducing their fears. Sixty-four percent said that without the program they might not have sought dental treatment. (Consumer Summary produced by Reliance Medical Information, Inc.)
Publication Name: Journal of the American Dental Association
Subject: Health
ISSN: 0002-8177
Year: 1990
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Dental phobia: conquering fear with trust
Article Abstract:
Half the people in the United States are said to fear going to the dentist, and 30 million of these are considered to have such a severe fear or phobia that they avoid going to the dentist at all. A woman with dental phobia was interviewed and her case is reported. She entered a Dental Fear Program and after two sessions X-rays were taken and she was able to agree to a dental treatment plan. By replacing their fear responses with new behavior, patients like this woman are able to overcome their phobia. Dental anxiety clinics have been established by several universities and medical centers throughout the country. Systematic desensitization and relaxation techniques are often employed. According to one clinic director, usually within three sessions a patient can accept an injection without experiencing an anxiety reaction. Methods for helping the fearful patient are outlined. The general dental practitioner plays an important role in preventing fears, and is encouraged to talk with the patient if fear is suspected. The fearful geriatric patient may remember the days of less sophisticated dentistry. Treatment of these patients requires special considerations. It is important to diagnose the anxious dental patient; frequently they try to hide their fears. There are certain characteristics to look for, such as missed appointments, embarrassment at dental condition, tension, fidgeting, visiting only for emergency dental work and tearful or excessively compliant behavior. Sometimes just asking a patient if he/she is anxious, is the best method of diagnosis. (Consumer Summary produced by Reliance Medical Information, Inc.)
Publication Name: Journal of the American Dental Association
Subject: Health
ISSN: 0002-8177
Year: 1989
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