The Effects of Propranolol on Fear of Tooth or Molar Extraction
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|ClinicalTrials.gov Identifier: NCT02268357|
Recruitment Status : Unknown
Verified August 2016 by Prof. dr. J. de Lange, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA).
Recruitment status was: Recruiting
First Posted : October 20, 2014
Last Update Posted : August 11, 2016
|Condition or disease||Intervention/treatment||Phase|
|Dental Anxiety||Drug: Propranolol||Phase 2 Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||34 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Effects of Propranolol on Fear of Dental Extraction: Study Protocol for a Randomized Placebo-controlled Trial.|
|Study Start Date :||October 2014|
|Estimated Primary Completion Date :||August 2018|
|Estimated Study Completion Date :||August 2018|
capsules PROPRANOLOL (study medication); 80 mg 1 hour preoperative; 40 mg directly postoperative
Oral propranolol capsules
Placebo Comparator: Placebo
capsules MICROCRYSTALLINE CELLULOSE (study medication); 80 mg 1 hour preoperative; 40 mg directly postoperative
Oral propranolol capsules
- Change from baseline at 1 month follow-up in Short version of the Dental Anxiety Inventory (S-DAI) [ Time Frame: Change from baseline at 1 month follow-up ]dental trait anxiety
- Change from baseline at 1 month follow-up in Self-reported vividness and emotional charge of the crucial fear-related memory [ Time Frame: Change from Baseline at 1 month follow-up ]Visual analogue scale
- Change from baseline at 1 month follow-up in State anxiety during treatment [ Time Frame: Change from Baseline at 1 month follow-up ]Visual analogue scale
- Change from baseline at 1 month follow-up in Physiological parameters (heart rate and blood pressure) during recall of the crucial fear-related memory [ Time Frame: Change from Baseline at 1 month follow-up ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02268357
|Contact: prof. dr. J. de Lange, MD, DDS, PhDemail@example.com|
|Contact: S. A. Steenen, MDfirstname.lastname@example.org|
|Dept. of Oral and Maxillofacial Surgery, Academic Medical Center, University of Amsterdam||Recruiting|
|Amsterdam, Netherlands, 1105 AZ|
|Contact: S. A. Steenen, MD email@example.com|
|Principal Investigator:||prof. dr. J. de Lange, MD, DDS, PhD||Academic Medical Center (AMC) of Amsterdam|
|Study Director:||prof. dr. A. de Jongh, DDS, PhD||Academic Center for Dentistry Amsterdam (ACTA), University of Amsterdam|