Dental Anxiety Clinical Trial
Official title:
Effects of Propranolol on Fear of Dental Extraction: Study Protocol for a Randomized Placebo-controlled Trial.
Randomized, placebo-controlled, double-blind, parallel group clinical trial evaluating the anxiolytic effects of propranolol on fear of wisdom tooth removal. It is hypothesized that, compared to placebo, perioperative oral propranolol reduces dental trait anxiety at 1 month follow-up after wisdom tooth removal.
RATIONALE Tooth and molar removals are among the most feared interventions in dentistry and
oral and maxillofacial surgery (OMFS). Anxiety for these procedures not only produces
discomfort to the patient, but may also induce patient behavior that impedes surgery, thereby
increasing operative time and complicating postoperative recovery. In addition, it has been
found that having undergone an extraction poses a significantly increased risk for developing
chronic apprehension for dental surgical procedures, disproportionate forms of dental anxiety
(i.e., dental phobia), and symptoms of post-traumatic stress. Addressing these problems
effectively requires an intervention that reduces both state anxiety during surgery and
dental trait anxiety in the long term.
OBJECTIVE The purpose of this trial is to determine the anxiolytic effects of the
ß-adrenoreceptor antagonist propranolol on patients with high levels of fear in anticipation
of dental extraction.
METHODS Trial design: Randomized, placebo-controlled, two-group, parallel, double-blind,
single center trial of 34 participants. Population and recruitment: Consecutive patients,
referred by their dentist to the department of Oral and Maxillofacial Surgery of the Academic
Medical Center of the University Amsterdam, for at least two tooth and/or molar removals,
with self-reported high to extreme fear in anticipation of dental extraction. Intervention:
Two 40 mg propranolol capsules one hour prior to dental extraction, followed by one 40 mg
capsule directly postoperatively. Comparator: Placebo capsules. Primary outcome: Dental trait
anxiety score reduction from baseline to 4-weeks follow-up. Secondary outcomes: Self-reported
anxiety during surgery; physiological parameters (heart rate and blood pressure) during
recall of the crucial fear-related memory; self-reported vividness and emotional charge of
the crucial fear-related memory.
RISKS AND BENEFITS ASSOCIATED WITH PARTICIPATION Participants of the trial will undergo
regular dental extraction procedures (treatment as usual), with an additional potentially
anxiolytic pharmacological intervention (propranolol) or placebo. The most important known
side-effects of propranolol are mild and self-limiting.
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