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The effects of propranolol on fear of wisdom tooth removal: A randomized, placebo-controlled, double-blind, parallel design trial


- candidate number8196
- NTR NumberNTR2398
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR1-jul-2010
- Secondary IDs10/062 / NL31184.018.10 ; METC AMC / CCMO
- Public TitleThe effects of propranolol on fear of wisdom tooth removal: A randomized, placebo-controlled, double-blind, parallel design trial
- Scientific TitleThe effects of propranolol on fear of wisdom tooth removal: A randomized, placebo-controlled, double-blind, parallel design trial
- ACRONYM
- hypothesisIn line with studies of propranolol in posttraumatic stress disorder, we hypothesize that propranolol:
1. Will alleviate emotional arousal during treatment;
2. Will diminish emotional intensitity of traumatic memory of (a) the phobia's core traumatic event (b) the latest dental treatment;
3. Will diminish odontophobia in the long term .
- Healt Condition(s) or Problem(s) studiedDental phobia, Specific phobia, blood-injection-injury type
- Inclusion criteria1. Fulfilling the diagnostic criteria for Specific Phobia, blood-injury-injection type according to the DSM-IV-TR;
2. Age above 18 years.
- Exclusion criteria1. Systolic blood pressure < 100mmHg;
2. Allergic asthma, Decompensatio cordis, Cardiac arrythmia or Insulin-dependent diabetes;
3. Previous adverse reaction to a beta-blocking agent;
4. Use of another beta-blocking agent;
5. Pregnant or breast feeding;
6. Being in psychotherapy elsewhere;
7. Renal failure.
- mec approval receivedno
- multicenter trialno
- randomisedyes
- masking/blindingTriple
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-aug-2010
- planned closingdate1-mei-2011
- Target number of participants60
- InterventionsAt day one:
Dental treatment (fillings, root canal treatments, extractions) and randomization to either:
1. Propranolol 80 mg prior to, and 40 mg directly after treatment, or;
2. Placebo 80 mg prior to, and 40 mg directly after treatment.

At day 30:
Dental treatment (fillings, root canal treatments, extractions).
- Primary outcome1. Dental anxiety (as measured by the short version of the Dental Anxiety Scale; S-DAI);
2. Emotional disregulation in reaction to exposure to traumatic memory (as measured by the Impact of Event Scale Revised; IES-R).
- Secondary outcome1. Visual analogue scales (VASs) for anxiety, various emotions and pain during treatment;
2. Physiological parameters (heartrate and bloodpressure).
- TimepointsPatients are assessed at four time points:
1. Before treatment;
2. Shortly before and after the first treatment sessions (day 1);
3. Shortly before and after the second treatment session (day 30).
- Trial web siteN/A
- statusstopped
- CONTACT FOR PUBLIC QUERIESProf. Dr. A. Jongh, de
- CONTACT for SCIENTIFIC QUERIESProf. Dr. A. Jongh, de
- Sponsor/Initiator Academic Center Dentistry Amsterdam (ACTA)
- Funding
(Source(s) of Monetary or Material Support)
Academical Center for Dentistry Amsterdam (ACTA)
- PublicationsN/A
- Brief summaryGrowing evidence suggests that beta-blocking agents reduce fearful memory. The current study aims to evaluate the effects of propranolol in the treatment of dental fear and phobia.

Research objectives are to evaluate the effect of propranolol (120 mg) in dental anxiety on:
1. Emotional arousal during treatment;
2. Emotional intensitity of traumatic memory of (a) the phobia's core traumatic event (b) the latest dental treatment;
3. Dental phobia in the long term.
- Main changes (audit trail)New hypothesis:
We hypothesize that subjects taking propranolol (1h preoperative and directly postoperative) will report:
1. lower levels of state anxiety
2. lower levels of dental trait anxiety
3. lower levels of aversive traumatic memory
4. lower levels of physiological arousal before a next procedure


Inclusion criteria 1. changed into 1. Excessive anxiety for necessary third molar extraction

- PLANNED STARTDATE 1-mar-2014
- PLANNED CLOSINGDATE 1-mar-2015

Timpepoitns: Patients are assessed at three time points:
1. Shortly before and after the first treatment sessions (day 1);
2. Shortly before and after the second treatment session (day 30).


Interventions:
At day one:
Third molar removal:
1. Propranolol 80 mg prior to, and 40 mg directly after treatment, or;
2. Placebo 80 mg prior to, and 40 mg directly after treatment.
At day 30: Third molar removal.
Primary outcome: - emotional intensity and vividness of traumatic memory
- state anxiety
- trait anxiety
- heart rate, blood pressure


Secondary outcome: - PTSD-sympom severity and dental phobia
- RECORD1-jul-2010 - 6-okt-2015


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