Comparative Evaluation of Three Anxiety Control Protocols in Third Molar Extraction

NCT03165500 | Completed Early Phase 1 DMC

• 1 other identifier: Universidade Estadual Paulista
• Study Type: interventional
• Target: 3
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Anxiety Disease

Keywords

Exodontia; Sedation; Nitrous Oxide; Benzodiazepines

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Assessment of heart rate change

  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

• Assessment of oxygen saturation change

  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 (2)

• Retrograde amnesia

  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

• Test of Trieger

  Measured 15 minutes after the end of surgery.]

Study Arms (3)

Diazepam

ACTIVE COMPARATOR

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.

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

Midazolam

ACTIVE COMPARATOR

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.

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

Nitrous Oxide + Oxygen Gas

ACTIVE COMPARATOR

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.

Drug: Diazepam; Drug: Midazolam; Procedure: Third molar extraction

Interventions

Diazepam 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.

Also known as: Valium, Diazepam 5mg

Midazolam; Nitrous Oxide + Oxygen Gas

Midazolam 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.

Also known as: Dormonid, Midazolam Oral Tablet

Diazepam; Nitrous Oxide + Oxygen Gas

Nitrous Oxide + Oxygen Gas 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).

Also known as: Nitrous Oxide, Nitrous Oxide Inhalant Product

Diazepam; Midazolam

Third molar extraction PROCEDURE

Anxious patients in need of third molar extraction

Also known as: Third molar surgery

Diazepam; Midazolam; Nitrous Oxide + Oxygen Gas

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Universidade Estadual Paulista Júlio de Mesquita Filho: lead

Related Publications (3)

• 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.

  PMID: 27994412 RESULT

• 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.

  PMID: 31377 RESULT

• 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.

  PMID: 25488309 RESULT

MeSH Terms

Interventions

Diazepam; Midazolam; Nitrous Oxide

Intervention Hierarchy (Ancestors)

Benzodiazepinones; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nitrogen Oxides; Gases; Inorganic Chemicals; Nitrogen Compounds; Oxides; Oxygen Compounds

Study Officials

• Michelle B Moraes, PHD

  ICT-UNESP

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Assistente Doutor - Departamento de Diagnóstico e Cirurgia - São Paulo State University (Unesp), Institute of Science and Technology, São José dos Campos, Brasil.

Model Details: 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.

Study Record Dates

• First Submitted: May 17, 2017
• First Posted: May 24, 2017
• Study Start: December 23, 2015
• Primary Completion: December 20, 2016
• Study Completion: May 4, 2017
• Last Updated: May 24, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share