Comparative Evaluation of Three Anxiety Control Protocols in Third Molar Extraction

Study Results

Results pending

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

3 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-23

Study Completion Date

2017-05-04

Brief Summary

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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.

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Detailed Description

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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%.

Conditions

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Anxiety Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Diazepam

Sedation of the anxious patient with diazepam 5 mg for measuring vital signs (blood pressure, heart rate, oxygen saturation) in the pre, trans and postoperative periods of third molar extraction.

Group Type ACTIVE_COMPARATOR

Midazolam

Intervention Type DRUG

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

Intervention Type DRUG

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).

Third molar extraction

Intervention Type PROCEDURE

Anxious patients in need of third molar extraction

Midazolam

Sedation of the anxious patient with midazolam 7.5 mg for measurement of vital signs (blood pressure, heart rate, oxygen saturation) in the pre, trans and postoperative periods of third molar extraction.

Group Type ACTIVE_COMPARATOR

Diazepam

Intervention Type DRUG

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.

Nitrous Oxide + Oxygen Gas

Intervention Type DRUG

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).

Third molar extraction

Intervention Type PROCEDURE

Anxious patients in need of third molar extraction

Nitrous Oxide + Oxygen Gas

Inhaled sedation of the mixture of 40% of nitrous oxide and 60% of oxygen gas for measurement of vital signs (blood pressure, heart rate, oxygen saturation) in the pre, trans and postoperative periods of third molar extraction.

Group Type ACTIVE_COMPARATOR

Diazepam

Intervention Type DRUG

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

Intervention Type DRUG

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.

Third molar extraction

Intervention Type PROCEDURE

Anxious patients in need of third molar extraction

Interventions

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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.

Intervention Type DRUG

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.

Intervention Type DRUG

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).

Intervention Type DRUG

Third molar extraction

Anxious patients in need of third molar extraction

Intervention Type PROCEDURE

Other Intervention Names

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Valium Diazepam 5mg Dormonid Midazolam Oral Tablet Nitrous Oxide Nitrous Oxide Inhalant Product Third molar surgery

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Michelle Bianchi de Moraes

Professor Assistente Doutor - Departamento de Diagnóstico e Cirurgia - São Paulo State University (Unesp), Institute of Science and Technology, São José dos Campos, Brasil.

Responsibility Role PRINCIPAL_INVESTIGATOR