The Effects of Propranolol on Fear of Tooth or Molar Extraction

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Effects of Propranolol on Fear of Dental Extraction: Study Protocol for a Randomized Placebo-controlled Trial.

Conditions
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Dental Anxiety

Intervention / Treatment
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* Drug: Propranolol


Participation Criteria
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Eligibility Criteria
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Inclusion criteria Signed written informed consent ≥ 18 Years of age on entry to the study Self-reported high to extreme fear of tooth or molar removal Dutch or English-speaking Exclusion criteria Asthma or other obstructive pulmonary disease Cardiac failure Cardiac arrhythmia Renal failure Insulin-dependent diabetes mellitus Pregnant or breast-feeding Current use of another ß-adrenoreceptor antagonist Current use of anxiolytic or antidepressant medication Currently in psychotherapy for dental anxiety Systolic blood pressure < 100 mmHg

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Propranolol<br>capsules PROPRANOLOL (study medication); 80 mg 1 hour preoperative; 40 mg directly postoperative | Drug: Propranolol<br>* Oral propranolol capsules<br>* Other names: propranolol HCl;|
| Placebo Comparator: Placebo<br>capsules MICROCRYSTALLINE CELLULOSE (study medication); 80 mg 1 hour preoperative; 40 mg directly postoperative | Drug: Propranolol<br>* Oral propranolol capsules<br>* Other names: propranolol HCl;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline at 1 month follow-up in Short version of the Dental Anxiety Inventory (S-DAI) | dental trait anxiety | Change from baseline at 1 month follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline at 1 month follow-up in Self-reported vividness and emotional charge of the crucial fear-related memory | Visual analogue scale | Change from Baseline at 1 month follow-up | 
| Change from baseline at 1 month follow-up in State anxiety during treatment | Visual analogue scale | Change from Baseline at 1 month follow-up | 
| Change from baseline at 1 month follow-up in Physiological parameters (heart rate and blood pressure) during recall of the crucial fear-related memory |  | Change from Baseline at 1 month follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dental Anxiety, Tooth Extraction, Propranolol