Clinical trial NCT03165500: Comparative Evaluation of Three Anxiety Control Protocols in Third Molar Extraction
Official title: Comparative Evaluation of Three Anxiety Control Protocols in Third Molar Extraction With Midazolam, Diazepam and Nitrous Oxide - Randomized Clinical Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Anxiety Disease
Keywords: Exodontia
Sedation
Nitrous Oxide
Benzodiazepines
Lead sponsor: Universidade Estadual Paulista Júlio de Mesquita Filho
Sponsor class: OTHER
First posted: 2017-05-24
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

Brief 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%.

Eligibility criteria: 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)

Primary outcomes:
measure: Assessment of blood pressure change
timeFrame: 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 outcomes:
measure: Assessment of heart rate change
timeFrame: 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
measure: Assessment of oxygen saturation change
timeFrame: 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
Other outcomes:
measure: Retrograde amnesia
timeFrame: 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
measure: Test of Trieger
timeFrame: Measured 15 minutes after the end of surgery.]
Locations:
Study officials:
affiliation: ICT-UNESP
name: Michelle B Moraes, PHD
role: PRINCIPAL_INVESTIGATOR
References:
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):464-468. doi: 10.4103/0976-237X.194125.
citation: Corah NL, Gale EN, Illig SJ. Assessment of a dental anxiety scale. J Am Dent Assoc. 1978 Nov;97(5):816-9. doi: 10.14219/jada.archive.1978.0394.
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.joms.2014.08.033. Epub 2014 Sep 16.