The Effects of Propranolol on Fear of Tooth or Molar Extraction

Dental Anxiety Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02268357
• Other study ID #: NL42210.018.13
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: November 2014
• Est. completion date: December 2018

Study information

• Verified date: April 2020
• Source: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dental Anxiety

Intervention

Drug:
• Propranolol
Oral propranolol capsules

Locations

Country	Name	City	State
Netherlands	Dept. of Oral and Maxillofacial Surgery, Academic Medical Center, University of Amsterdam	Amsterdam

Sponsors (1)

Lead Sponsor	Collaborator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Country where clinical trial is conducted

Netherlands, 

References & Publications (3)

Brunet A, Orr SP, Tremblay J, Robertson K, Nader K, Pitman RK. Effect of post-retrieval propranolol on psychophysiologic responding during subsequent script-driven traumatic imagery in post-traumatic stress disorder. J Psychiatr Res. 2008 May;42(6):503-6. Epub 2007 Jun 22. — View Citation

Liu HH, Milgrom P, Fiset L. Effect of a beta-adrenergic blocking agent on dental anxiety. J Dent Res. 1991 Sep;70(9):1306-8. — View Citation

Lonergan MH, Olivera-Figueroa LA, Pitman RK, Brunet A. Propranolol's effects on the consolidation and reconsolidation of long-term emotional memory in healthy participants: a meta-analysis. J Psychiatry Neurosci. 2013 Jul;38(4):222-31. doi: 10.1503/jpn.120111. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Change from baseline at 1 month follow-up in State anxiety during treatment	Visual analogue scale	Change from Baseline at 1 month follow-up
Secondary	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