Ignite Creation Date:
2025-12-24 @ 6:32 PM
Ignite Modification Date:
2026-01-26 @ 10:18 PM
Study NCT ID:
NCT02268357
Status:
COMPLETED
Last Update Posted:
2020-04-17
First Post:
2014-10-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effects of Propranolol on Fear of Tooth or Molar Extraction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D011433', 'term': 'Propranolol'}], 'ancestors': [{'id': 'D050198', 'term': 'Phenoxypropanolamines'}, {'id': 'D011412', 'term': 'Propanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D020005', 'term': 'Propanols'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009281', 'term': 'Naphthalenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2018-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-04-16', 'studyFirstSubmitDate': '2014-10-07', 'studyFirstSubmitQcDate': '2014-10-17', 'lastUpdatePostDateStruct': {'date': '2020-04-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-10-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline at 1 month follow-up in Short version of the Dental Anxiety Inventory (S-DAI)', 'timeFrame': 'Change from baseline at 1 month follow-up', 'description': 'dental trait anxiety'}], 'secondaryOutcomes': [{'measure': 'Change from baseline at 1 month follow-up in Self-reported vividness and emotional charge of the crucial fear-related memory', 'timeFrame': 'Change from Baseline at 1 month follow-up', 'description': 'Visual analogue scale'}, {'measure': 'Change from baseline at 1 month follow-up in State anxiety during treatment', 'timeFrame': 'Change from Baseline at 1 month follow-up', 'description': 'Visual analogue scale'}, {'measure': 'Change from baseline at 1 month follow-up in Physiological parameters (heart rate and blood pressure) during recall of the crucial fear-related memory', 'timeFrame': 'Change from Baseline at 1 month follow-up'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Dental Anxiety', 'Tooth Extraction', 'Propranolol'], 'conditions': ['Dental Anxiety']}, 'referencesModule': {'references': [{'pmid': '1918581', 'type': 'BACKGROUND', '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. doi: 10.1177/00220345910700091401.'}, {'pmid': '17588604', 'type': 'BACKGROUND', 'citation': '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': '23182304', 'type': 'BACKGROUND', '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."}, {'pmid': '26607848', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nOBJECTIVE 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.\n\nMETHODS 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.\n\nRISKS 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria\n\n1. Signed written informed consent\n2. ≥ 18 Years of age on entry to the study\n3. Self-reported high to extreme fear of tooth or molar removal\n4. Dutch or English-speaking\n\nExclusion criteria\n\n1. Asthma or other obstructive pulmonary disease\n2. Cardiac failure\n3. Cardiac arrhythmia\n4. Renal failure\n5. Insulin-dependent diabetes mellitus\n6. Pregnant or breast-feeding\n7. Current use of another ß-adrenoreceptor antagonist\n8. Current use of anxiolytic or antidepressant medication\n9. Currently in psychotherapy for dental anxiety\n10. Systolic blood pressure \\< 100 mmHg'}, 'identificationModule': {'nctId': 'NCT02268357', 'briefTitle': 'The Effects of Propranolol on Fear of Tooth or Molar Extraction', 'organization': {'class': 'OTHER', 'fullName': 'Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)'}, 'officialTitle': 'Effects of Propranolol on Fear of Dental Extraction: Study Protocol for a Randomized Placebo-controlled Trial.', 'orgStudyIdInfo': {'id': 'NL42210.018.13'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Propranolol', 'description': 'capsules PROPRANOLOL (study medication); 80 mg 1 hour preoperative; 40 mg directly postoperative', 'interventionNames': ['Drug: Propranolol']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'capsules MICROCRYSTALLINE CELLULOSE (study medication); 80 mg 1 hour preoperative; 40 mg directly postoperative', 'interventionNames': ['Drug: Propranolol']}], 'interventions': [{'name': 'Propranolol', 'type': 'DRUG', 'otherNames': ['propranolol hydrochloride', 'propranolol HCl'], 'description': 'Oral propranolol capsules', 'armGroupLabels': ['Placebo', 'Propranolol']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1105 AZ', 'city': 'Amsterdam', 'country': 'Netherlands', 'facility': 'Dept. of Oral and Maxillofacial Surgery, Academic Medical Center, University of Amsterdam', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}], 'overallOfficials': [{'name': 'prof. dr. J. de Lange, MD, DDS, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Academic Medical Center (AMC) of Amsterdam'}, {'name': 'prof. dr. A. de Jongh, DDS, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Academic Center for Dentistry Amsterdam (ACTA), University of Amsterdam'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'prof. dr. J. de Lange (mandated sponsor/principal investigator)', 'investigatorFullName': 'Prof. dr. J. de Lange', 'investigatorAffiliation': 'Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)'}}}}