Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 7 of 294 for:    PROPRANOLOL

The Effects of Propranolol on Fear of Tooth or Molar Extraction

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Information provided by (Responsible Party):
Prof. dr. J. de Lange, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Brief 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.

Condition or disease Intervention/treatment Phase
Dental Anxiety Drug: Propranolol Phase 2 Phase 3

Detailed 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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Experimental: Propranolol
capsules PROPRANOLOL (study medication); 80 mg 1 hour preoperative; 40 mg directly postoperative
Drug: Propranolol
Oral propranolol capsules
Other Names:
  • propranolol hydrochloride
  • propranolol HCl

Placebo Comparator: Placebo
capsules MICROCRYSTALLINE CELLULOSE (study medication); 80 mg 1 hour preoperative; 40 mg directly postoperative
Drug: Propranolol
Oral propranolol capsules
Other Names:
  • propranolol hydrochloride
  • propranolol HCl




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Contacts
Layout table for location contacts
Contact: prof. dr. J. de Lange, MD, DDS, PhD j.delange@amc.uva.nl
Contact: S. A. Steenen, MD s.a.steenen@amc.uva.nl

Locations
Layout table for location information
Netherlands
Dept. of Oral and Maxillofacial Surgery, Academic Medical Center, University of Amsterdam Recruiting
Amsterdam, Netherlands, 1105 AZ
Contact: S. A. Steenen, MD       s.a.steenen@amc.uva.nl   
Sponsors and Collaborators
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Investigators
Layout table for investigator information
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

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Prof. dr. J. de Lange, prof. dr. J. de Lange (mandated sponsor/principal investigator), Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
ClinicalTrials.gov Identifier: NCT02268357     History of Changes
Other Study ID Numbers: NL42210.018.13
First Posted: October 20, 2014    Key Record Dates
Last Update Posted: August 11, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Prof. dr. J. de Lange, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA):
Dental Anxiety
Tooth Extraction
Propranolol
Additional relevant MeSH terms:
Layout table for MeSH terms
Propranolol
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Antihypertensive Agents
Vasodilator Agents