Comparative Evaluation of Three Anxiety Control Protocols in Third Molar Extraction

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03165500
• Other study ID #: Universidade Estadual Paulista
• Status: Completed
• Phase: Early Phase 1
• First received: May 17, 2017
• Last updated: May 22, 2017
• Start date: December 23, 2015
• Est. completion date: May 4, 2017

Study information

• Verified date: May 2017
• Source: Universidade Estadual Paulista Júlio de Mesquita Filho
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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%.

Recruitment information / eligibility

• 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)

Related Conditions & MeSH terms

• Anxiety Disease
• Anxiety Disorders

Intervention

Drug:
• Diazepam
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.
• Midazolam
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.
• Nitrous Oxide + Oxygen Gas
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).

Procedure:
• Third molar extraction
Anxious patients in need of third molar extraction

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Estadual Paulista Júlio de Mesquita Filho

References & Publications (3)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
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