NCT02268357

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Nov 2014

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 7, 2014

Completed
13 days until next milestone

First Posted

Study publicly available on registry

October 20, 2014

Completed
12 days until next milestone

Study Start

First participant enrolled

November 1, 2014

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

April 17, 2020

Status Verified

April 1, 2020

Enrollment Period

4.1 years

First QC Date

October 7, 2014

Last Update Submit

April 16, 2020

Conditions

Dental Anxiety

Keywords

Dental AnxietyTooth ExtractionPropranolol

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Change from baseline at 1 month follow-up in Self-reported vividness and emotional charge of the crucial fear-related memory

    Change from Baseline at 1 month follow-up

  • Change from baseline at 1 month follow-up in State anxiety during treatment

    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

Study Arms (2)

Propranolol

EXPERIMENTAL

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

Drug: Propranolol

Placebo

PLACEBO COMPARATOR

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

Drug: Propranolol

Interventions

PropranololDRUG

Oral propranolol capsules

Also known as: propranolol hydrochloride, propranolol HCl
PlaceboPropranolol

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept. of Oral and Maxillofacial Surgery, Academic Medical Center, University of Amsterdam

Amsterdam, 1105 AZ, Netherlands

Location

Related Publications (4)

  • 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. doi: 10.1177/00220345910700091401.

    PMID: 1918581BACKGROUND

  • 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. doi: 10.1016/j.jpsychires.2007.05.006. Epub 2007 Jun 22.

    PMID: 17588604BACKGROUND

  • 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.

    PMID: 23182304BACKGROUND

  • Steenen SA, van Wijk AJ, van Westrhenen R, de Lange J, de Jongh A. Effects of propranolol on fear of dental extraction: study protocol for a randomized controlled trial. Trials. 2015 Nov 25;16:536. doi: 10.1186/s13063-015-1065-7.

    PMID: 26607848DERIVED

MeSH Terms

Interventions

Propranolol

Intervention Hierarchy (Ancestors)

PhenoxypropanolaminesPropanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsPropanolsAminesNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPolycyclic Compounds

Study Officials

  • prof. dr. J. de Lange, MD, DDS, PhD

    Academic Medical Center (AMC) of Amsterdam

    PRINCIPAL INVESTIGATOR

  • prof. dr. A. de Jongh, DDS, PhD

    Academic Center for Dentistry Amsterdam (ACTA), University of Amsterdam

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
prof. dr. J. de Lange (mandated sponsor/principal investigator)

Study Record Dates

First Submitted

October 7, 2014

First Posted

October 20, 2014

Study Start

November 1, 2014

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

April 17, 2020

Record last verified: 2020-04

Locations

NL(1)