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Anxiety | Efficacy of Clonidine and Propranolol in Dentistry (AAA)

Anxiety research study

What is the primary objective of this study?

The aim of the study is to determine the efficacy of clonidine and propranolol for transient anxiety management and intra and postoperative pain in patients undergoing ambulatory surgery of third molar.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Anxiety

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:ClonidineClonidine 150 mcg tablet single dose, to receive by mouth one hour before surgery

Drug:PropranololPropranolol 40 mg tablet single dose, to receive by mouth one hour before surgery

Drug:PlaceboSugar pill manufactured to mimic a drug

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

PropanololPropranolol 40mg tablets, one tablet administered 1 hour before surgery

PlaceboPlacebo tablets, one tablet administered 1 hour before surgery

Clonidineclonidine 150mcg tablets, one tablet administered 1 hour before surgery

Study Status

Unknown status

Start Date: August 2012

Completed Date: April 2013

Phase: Phase 2

Type: Interventional

Design:

Primary Outcome: 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

Secondary Outcome: Changes in Verbal Numerical Rating Scale (VNRS) at three, six, and twenty-four hours post treatment

Study sponsors, principal investigator, and references

Principal Investigator: Patricia Bermudez, Dentistry

Lead Sponsor: CES University

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01784250

Ng SK, Leung WK. A community study on the relationship of dental anxiety with oral health status and oral health-related quality of life. Community Dent Oral Epidemiol. 2008 Aug;36(4):347-56.

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