Dental AnxietyPhase 2/3NCT02268357
The Effects of Propranolol on Fear of Tooth or Molar Extraction
A Phase 2/3 study testing Propranolol in people with Dental Anxiety, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dental Anxiety
- What is being tested?
- Propranolol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteNetherlands
- Study dates
- Nov 2014to Dec 2018
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Asthma or other obstructive pulmonary disease
- Cardiac failure
- Cardiac arrhythmia
- Renal failure
- Insulin-dependent diabetes mellitus
- Pregnant or breast-feeding
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Dept. of Oral and Maxillofacial Surgery, Academic Medical Center, University of Amsterdam
Amsterdam, 1105 AZ
About this study
Official title: Effects of Propranolol on Fear of Dental Extraction: Study Protocol for a Randomized Placebo-controlled Trial.
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.
Read the 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.
- Conditions
- Dental Anxiety
- Being tested
- Propranolol
- Keywords
- Dental Anxiety, Tooth Extraction, Propranolol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PropranololDrug
Also called propranolol hydrochloride, propranolol HCl
Oral propranolol capsules
| Study group | Role | What they receive |
|---|---|---|
| Propranolol | Experimental | capsules PROPRANOLOL (study medication); 80 mg 1 hour preoperative; 40 mg directly postoperative Receives: Drug: Propranolol |
| Placebo | Placebo comparator | capsules MICROCRYSTALLINE CELLULOSE (study medication); 80 mg 1 hour preoperative; 40 mg directly postoperative Receives: Drug: Propranolol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline at 1 month follow-up in Short version of the Dental Anxiety Inventory (S-DAI)
dental trait anxiety
Measured: 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
Visual analogue scale
Measured: Change from Baseline at 1 month follow-up
Change from baseline at 1 month follow-up in State anxiety during treatment
Visual analogue scale
Measured: 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
Measured: Change from Baseline at 1 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2014 (estimated)
- Study startNov 2014
- Primary completionDec 2018
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Dental AnxietyStudies of the same condition, open and under way.
- More trials run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. dr. J. de Lange, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Investigators
- prof. dr. J. de Lange, MD, DDS, PhD, Principal investigator, Academic Medical Center (AMC) of Amsterdamprof. dr. A. de Jongh, DDS, PhD, Study director, Academic Center for Dentistry Amsterdam (ACTA), University of Amsterdam
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02268357
- Sponsor's protocol ID
- NL42210.018.13
- Status last verified
- Apr 2020
- First submitted
- 7 Oct 2014
- Last updated
- 17 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
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.
PubMed 1918581Brunet 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.
PubMed 17588604Lonergan 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.
PubMed 23182304Steenen 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.
PubMed 26607848
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Propranolol on Fear of Dental Extraction: Study Protocol for a Randomized Placebo-controlled Trial.
- ClinicalTrials.gov ID
- NCT02268357
- Acronym / sponsor ID
- NL42210.018.13
- Conditions
- Dental Anxiety
- Keywords
- Dental Anxiety, Tooth Extraction, Propranolol
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Study start
- Nov 2014 (actual)
- Primary completion
- Dec 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 20 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Propranolol | Experimental | Drug: Propranololcapsules PROPRANOLOL (study medication); 80 mg 1 hour preoperative; 40 mg directly postoperative |
| Placebo | Placebo comparator | Drug: Propranololcapsules MICROCRYSTALLINE CELLULOSE (study medication); 80 mg 1 hour preoperative; 40 mg directly postoperative |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- Asthma or other obstructive pulmonary disease
- Cardiac failure
- Cardiac arrhythmia
- Renal failure
- Insulin-dependent diabetes mellitus
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PropranololAlso: propranolol hydrochloride, propranolol HClOral propranolol capsules | Drug | Placebo, Propranolol |
Primary outcome
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
3 secondary outcomes
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
Change from baseline at 1 month follow-up in State anxiety during treatment
Time frame: 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
Time frame: Change from Baseline at 1 month follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2020.
- Background: PubMed 1918581Liu 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.
- Background: PubMed 17588604Brunet 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.
- Background: PubMed 23182304Lonergan 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.
- Derived from this study: PubMed 26607848Steenen 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
prof. dr. J. de Lange, MD, DDS, PhD principal investigator
Academic Medical Center (AMC) of Amsterdam
prof. dr. A. de Jongh, DDS, PhD study director
Academic Center for Dentistry Amsterdam (ACTA), University of Amsterdam
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Propranolol in people with Dental Anxiety, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02268357, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2020.