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ID
Source
Health condition
Dental phobia / Odontophobia / Specific phobia, blood-injection-injury type
Sponsors and support
Intervention
Outcome measures
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
Background summary
Growing 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.
Study objective
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
Study design
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).
Intervention
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.
Inclusion criteria
1. Excessive anxiety for necessary third molar extraction;
2. Age above 18 years.
Exclusion criteria
1. 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.
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
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In other registers
| Register | ID |
|---|---|
| NTR-new | NL2272 |
| NTR-old | NTR2398 |
| Other | METC AMC / CCMO : 10/062 / NL31184.018.10 ; |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |