Comparative Evaluation of Three Anxiety Control Protocols in Third Molar Extraction
Condition: Anxiety Disease
MeSH terms: Anxiety Disorders
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The surgery for the extraction of the third molars is a procedure in Dentistry that generates
      a large picture of anxiety in the patient. One of the ways to try to soften this picture, are
      the professionals to use sedation. Thus, the objective of this study was to evaluate three
      sedation protocols, and to compare them with vital signs values, in order to obtain the
      sedation method with greater patients stability.
    

Detailed description: 
      The surgery for the extraction of third molars is one of the procedures in Dentistry that
      generates a great picture of anxiety in the patients, due to the expectation of pain and
      discomfort in the postoperative period, but mainly in the trans-operative period. One of the
      ways to try to minimize this situation is to use sedation, which is a relatively safe
      procedure performed by trained professionals and with an accurate indication for anxious
      patients. There are several protocols in the literature, but few comparative studies. Thus,
      the objective of this study was to evaluate three sedation protocols. For this purpose, 120
      patients who required surgical treatment for extraction of third molars, aged between 18 and
      30 years, and whose anxiety was moderate to severe according to the Corah Anxiety Scale from
      the School of Dentistry of São José Dos Campos (UNESP). These patients were randomly divided
      into three Groups: Group I - oral sedation with diazempam 5 mg; Group II - oral sedation with
      midazolam 7.5 mg and Group III - inhalation sedation with 40% of nitrous oxide . Prior to
      sedation, anxiety was quantified through the Corah Anxiety Scale. Vital signs (blood
      pressure, heart rate and oxygen saturation) were measured before sedation, after sedation, in
      the trans-operative period and 15 minutes after the end of sedation. The results will be
      submitted to descriptive statistics and compared using the statistical analysis of variance
      (ANOVA) and Tukey test with significance level of 5%.
    

Intervention name(s): Diazepam; Midazolam; Nitrous Oxide + Oxygen Gas; Third molar extraction
Intervention type(s): Drug; Drug; Drug; Procedure
Intervention description(s): Patients' vital signs (blood pressure, heart rate and oxygen saturation) were measured and recorded after 30 minutes of oral sedation with diazepam 5mg, during the extraction procedure and 15 minutes after the extraction.
After the surgical procedure of extraction, the patients remained in recovery in the same room, being the criteria of discharge realized, from the normality of the vital signs and the response to the verbal commands, with the patient responsive and lucid.; Patients' vital signs (blood pressure, heart rate, and oxygen saturation) were measured and recorded after 30 minutes of oral sedation with midazolam 7.5mg during the extraction procedure and 15 minutes after the extraction.
After the surgical procedure of extraction, the patients remained in recovery in the same room, being the criteria of discharge realized, from the normality of the vital signs and the response to the verbal commands, with the patient responsive and lucid.; Patients' vital signs (blood pressure, heart rate, and oxygen saturation) were measured and recorded after 30 minutes of sedation Inhalation with the mixture of 40% of nitrou oxide and 60% of oxygen, during the exodontia procedure and 15 minutes later.
After the surgical procedure of extraction, the patients remained in recovery in the same room, being the discharge criteria performed, from the normality of the vital signs and the response to the verbal commands, with the patient responsive and lucid, and after the accomplishment of the test developed by Trieger et al.,(1971).; Anxious patients in need of third molar extraction
Other intervention name(s): Valium; Diazepam 5mg; Dormonid; Midazolam Oral Tablet; Nitrous Oxide; Nitrous Oxide Inhalant Product; Third molar surgery
Intervention MeSH terms: Midazolam; Diazepam; Nitrous Oxide
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The investigadors selected 120 third molars , with the need for exodontia, in patients aged 18 to 30 years, ASA I, and with moderate to high anxiety level according to the Corah Dental Anxiety Scale (DAS). Patients were randomly assigned to three groups of 40 patients and submitted to the following anxiety control protocol:
Group I - Sedation with 5 mg oral Diazepam 30 minutes before surgery;
Group II - Sedation with 7.5 mg oral Midazolam 30 minutes before surgery;
Group III - Inhaled sedation with a mixture of 40% of nitrous oxide and 60% of oxygen (Using the Porter MXR 3000 Flowmeter (Parker Hannifin - Hatfield, PA, Philadelphia)) started 5 minutes before surgery.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Exodontia; Sedation; Nitrous Oxide; Benzodiazepines