Anxiety Disease Clinical Trial
Official title:
Comparative Evaluation of Three Anxiety Control Protocols in Third Molar Extraction With Midazolam, Diazepam and Nitrous Oxide - Randomized Clinical Trial.
Verified date | May 2017 |
Source | Universidade Estadual Paulista Júlio de Mesquita Filho |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 3 |
Est. completion date | May 4, 2017 |
Est. primary completion date | December 20, 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 30 Years |
Eligibility |
Inclusion Criteria: - Healthy patients (ASA1), without surgical contra indications, requiring avulsion of the included third and / or semi-molar third molars, - Between the ages of 18 and 30, - Patients who agreed to voluntarily participate in the research, after knowing the risks and benefits, and signing the Informed Consent Form (TCLE). - Patients who presented moderate to high anxiety level in the questionnaire proposed by Corah in 1969. Exclusion Criteria: - Patients with any systemic or local change that contra indicated the procedure, - Use of anti-inflammatories in the last 15 days, - Pericoronitis, - Patients who did not accept the Informed Consent Form (TCLE) |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Universidade Estadual Paulista Júlio de Mesquita Filho |
Corah NL, Gale EN, Illig SJ. Assessment of a dental anxiety scale. J Am Dent Assoc. 1978 Nov;97(5):816-9. — View Citation
Joshi S, Ansari AS, Mazumdar S, Ansari S. A comparative study to assess the effect of oral alprazolam as premedication on vital parameters of patients during surgical removal of impacted mandibular third molars. Contemp Clin Dent. 2016 Oct-Dec;7(4):464-46 — View Citation
Khader R, Oreadi D, Finkelman M, Jarmoc M, Chaudhary S, Schumann R, Rosenberg M. A prospective randomized controlled trial of two different sedation sequences for third molar removal in adults. J Oral Maxillofac Surg. 2015 Feb;73(2):224-31. doi: 10.1016/j — View Citation
Type | Measure | Description | Time frame | Safety issue |
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Other | Retrograde amnesia | Evaluated in anxious patients submitted to the exodontia of third molars, sedated with diazepam, midazolam and nitrous oxide.Retrograde amnesia was evaluated by the investigator through the adapted test of Bulach et al., (2005), where 6 images were shown to the patient for a period of 5 seconds each | Immediately the arrival of the patient and before receiving sedation - 30 minutes after the patient receives oral sedation or 5 minutes after inhaled sedation- 15 minutes after the end of surgery | |
Other | Test of Trieger | Evaluated in anxious patients submitted to the exodontia of third molars, sedated with nitrous oxide. Only for the patients in the group undergoing nitrous oxide sedation, the test developed by Trieger et al., (1971) was performed according to Malamed (2012). The researcher provides a drawing to the patient for the union of the points closest to the ideal. | Measured 15 minutes after the end of surgery.] | |
Primary | Assessment of blood pressure change | Evaluated in anxious patients submitted to the exodontia of third molars, sedated with diazepam, midazolam and nitrous oxide.The investigator evaluated with auscultatory instrument. | Immediately the arrival of the patient and before receiving sedation - 30 minutes after the patient receives oral sedation or 5 minutes after inhaled sedation- During the exodontia - 15 minutes after the end of surgery | |
Secondary | Assessment of heart rate change | Evaluated in anxious patients submitted to the exodontia of third molars, sedated with diazepam, midazolam and nitrous oxide.The investigator evaluated with oscillometric monitor. | Immediately the arrival of the patient and before receiving sedation - 30 minutes after the patient receives oral sedation or 5 minutes after inhaled sedation- During the exodontia - 15 minutes after the end of surgery | |
Secondary | Assessment of oxygen saturation change | Evaluated in anxious patients submitted to the exodontia of third molars, sedated with diazepam, midazolam and nitrous oxide. The investigator evaluated with pulse oximeter | Immediately the arrival of the patient and before receiving sedation - 30 minutes after the patient receives oral sedation or 5 minutes after inhaled sedation- During the exodontia - 15 minutes after the end of surgery |
Status | Clinical Trial | Phase | |
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Recruiting |
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