The Effects of Propranolol on Fear of Tooth or Molar Extraction

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-30

Study Completion Date

2018-12-31

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.

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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.

Conditions

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Dental Anxiety

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Propranolol

capsules PROPRANOLOL (study medication); 80 mg 1 hour preoperative; 40 mg directly postoperative

Group Type EXPERIMENTAL

Propranolol

Intervention Type DRUG

Oral propranolol capsules

Placebo

capsules MICROCRYSTALLINE CELLULOSE (study medication); 80 mg 1 hour preoperative; 40 mg directly postoperative

Group Type PLACEBO_COMPARATOR

Propranolol

Intervention Type DRUG

Oral propranolol capsules

Interventions

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Propranolol

Oral propranolol capsules

Intervention Type DRUG

Other Intervention Names

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propranolol hydrochloride propranolol HCl

Eligibility Criteria

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Inclusion Criteria

1. Signed written informed consent
2. ≥ 18 Years of age on entry to the study
3. Self-reported high to extreme fear of tooth or molar removal
4. Dutch or English-speaking

Exclusion Criteria

1. Asthma or other obstructive pulmonary disease
2. Cardiac failure
3. Cardiac arrhythmia
4. Renal failure
5. Insulin-dependent diabetes mellitus
6. Pregnant or breast-feeding
7. Current use of another ß-adrenoreceptor antagonist
8. Current use of anxiolytic or antidepressant medication
9. Currently in psychotherapy for dental anxiety
10. Systolic blood pressure \< 100 mmHg

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No