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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT01784250 |
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Date of registration:
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23/01/2013 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Efficacy of Clonidine and Propranolol in Dentistry (AAA)
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Scientific title:
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Efficacy of Clonidine and Propranolol Versus Placebo for the Control of Anxiety During Surgical Procedures in Dentistry |
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Date of first enrolment:
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August 2012 |
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Target sample size:
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60 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01784250 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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Phase:
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Phase 2
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Countries of recruitment
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Colombia
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Contacts
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Name:
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Ana K Tamara, Physician |
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Address:
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Telephone:
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Email:
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Affiliation:
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CES University |
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Name:
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Patricia Bermudez, Dentistry |
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Address:
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Telephone:
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Email:
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patvanss@hotmail.com |
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Affiliation:
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Name:
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Libia M Rodriguez, Magister |
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Address:
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Telephone:
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Email:
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Affiliation:
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CES University |
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Name:
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Patricia Bermudez, Dentistry |
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Address:
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Telephone:
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Email:
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Affiliation:
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CES University |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Normotensive patients and pre-hypertension who are undergoing elective surgery for
removal of third molars.
- Age range 14 to 40 years
- Patients with dental anxiety above 13 points on the scale (MDAS).
- People who voluntarily agree to participate in the study and sign the informed
consent form
Exclusion Criteria:
- Patients receiving any medication for any chronic pathology.
- Patients of African American race, being more likely to have abnormal blood pressure.
- Patients with a history of cardiovascular disease.
- Patients with chronic systemic disease such as diabetes, hyper or hypothyroidism,
Addison's syndrome, renal failure, hypertension or liver disease.
- Pregnant or breastfeeding.
- Patients diagnosed with anxiety disorder or depressive disorder
Age minimum:
14 Years
Age maximum:
40 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Anxiety
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Intervention(s)
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Drug: Propranolol
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Drug: Placebo
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Drug: Clonidine
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Primary Outcome(s)
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Change from baseline in modified dental anxiety scale(MDAS)and vital signs (blood pressure, heart rate, respiratory rate, oxygen saturation) until four hours post treatment
[Time Frame: (plus or minus 4 hours) after surgery]
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Secondary Outcome(s)
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Changes in Verbal Numerical Rating Scale (VNRS) at three, six, and twenty-four hours post treatment
[Time Frame: 24 hours]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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