Comparative Evaluation of Three Anxiety Control Protocols in Third Molar Extraction

Universidade Estadual Paulista Júlio de Mesquita Filho

Status and phase: Completed; Early Phase 1

Conditions: Anxiety Disease

Treatments: Procedure: Third molar extraction; Drug: Midazolam; Drug: Nitrous Oxide + Oxygen Gas; Drug: Diazepam

Study type: Interventional

Funder types: Other

Identifiers

NCT03165500

Universidade Estadual Paulista

Details and patient eligibility

About

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.

Full 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%.

Enrollment: 3 patients

Sex: All

Ages: 18 to 30 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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3 participants in 3 patient groups

Diazepam

Active Comparator group

Description:

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.

Treatment:

Drug: Nitrous Oxide + Oxygen Gas

Drug: Midazolam

Procedure: Third molar extraction

Midazolam

Active Comparator group

Description:

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.

Treatment:

Drug: Diazepam

Drug: Nitrous Oxide + Oxygen Gas

Procedure: Third molar extraction

Nitrous Oxide + Oxygen Gas

Active Comparator group

Description:

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.

Treatment:

Drug: Diazepam

Drug: Midazolam

Procedure: Third molar extraction