The study, sponsored by the National Institute of Dental and Craniofacial Research (NIDCR) of the National Institutes of Health, is the largest prospective clinical study conducted to date on the safety and effectiveness of dental outpatient sedation.

"Fear of dental pain persists despite the decreased incidence of dental disease and continuing improvements in pain control," says the study's lead author, Raymond A. Dionne, D.D.S., Ph.D., clinical director of the NIDCR. He added that scientifically acceptable evidence was needed to support the practice of dental anesthesia and sedation.

In the study, 997 patients from five study sites were given different types of intravenous anesthesia while having their wisdom teeth out. The patients at each site were divided into five groups -- four received drug treatment and the fifth received a placebo.

Midazolam, a commonly used anti-anxiety drug, was evaluated either alone or in combination with other pain control and short-acting anesthetic drugs in each of the four drug treatment groups. All groups were also given local anesthesia.

All four treatments were found to provide therapeutic benefit to adults, with minimal incidence of potentially serious adverse effects. Of the four treatments, patients and oral surgeons alike rated the combination of midazolam, fentanyl and methohexital as most effective in relieving anxiety, controlling pain and blocking any unpleasant memories of the dental procedure.

This particular three-drug combination is characterized as deep sedation. Deep sedation can result in slower breathing rates, occasional apnea (which occurred in 50 percent of the sample studied), a slight decrease in blood oxygen levels and an occasional retention of carbon dioxide.

When deep sedation is used during dental procedures, careful monitoring is needed to detect changes that may result in significant adverse effects if not detected early, according to Dr. Dionne. Appropriate patient observation procedures and physiologic monitoring equipment were used in the study.

Because only young healthy adults were studied, Dr. Dionne cautions that further studies are needed regarding the safety and effectiveness of such sedation in children, seniors, patients with preexisting disease and patients being treated with other medication.

"Management of patients' fear and anxiety during dental treatment is a primary concern of dental practitioners," Dr. Dionne states. "The results of this large-scale study provide assurance to both the public and the dental profession of the safety of sedation with these drugs when administered slowly in the recommended doses by appropriately trained dentists."

The American Dental Association recommends that dentists administering general anesthesia or deep sedation have a minimum of two years additional training focusing extensively on these areas, beyond a dental degree, or have completed an ADA accredited postdoctoral training program, such as oral and maxillofacial surgery, which includes comprehensive and appropriate training necessary to administer and manage general anesthesia or deep sedation.

Related website:

American Dental Association

22-Jun-2001