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

The effects of propranolol on fear of tooth removal: A randomized, placebo-controlled, double-blind, parallel design trial - Is propranolol effective against dental fear ?

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON45112
Enrollment
70
Registered
2014-03-05
Start date
2014-11-11
Completion date
Unknown
Last updated
2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

(Dental) anxiety

Interventions

One hour prior to their treatment during which a tooth will be removed, patients receive 80 milligrams of propranolol. Propranolol is a beta blocker which previously has been shown to be effective i

Sponsors

Academisch Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1. Excessive anxiety for necessary tooth and/or molar extraction 2. Age above 18 years.

Exclusion criteria

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 outcomes

Primary

MeasureTime frame
- S-DAI score (short version of the Dental Anxiety Inventory) - emotional intensity and vividness of the traumatic memory that is presumed to have caused the anxiety for tooth extraction

Secondary

MeasureTime frame
- trauma-related (PTSD) symptom severity on a continuous scale the Dutch version of the Impact of Event Scale (IES; Weiss & Marmar, 1997) will be used. - the number of participants that meets the criteria for a specific phobia for dental treatment (as confirmed by the M.I.N.I. plus questionnaire) - degree of state anxiety - degree of trait anxiety - Physiological parameters; heart frequency and blood pressure

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)