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Comparative Evaluation of Three Anxiety Control Protocols in Third Molar Extraction

Primary Purpose

Anxiety Disease

Status
Completed
Phase
Early Phase 1
Locations
Study Type
Interventional
Intervention
Diazepam
Midazolam
Nitrous Oxide + Oxygen Gas
Third molar extraction
Sponsored by
Universidade Estadual Paulista Júlio de Mesquita Filho
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anxiety Disease focused on measuring Exodontia, Sedation, Nitrous Oxide, Benzodiazepines

Eligibility Criteria

18 Years - 30 Years (Adult)All SexesAccepts 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)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Active Comparator

    Active Comparator

    Arm Label

    Diazepam

    Midazolam

    Nitrous Oxide + Oxygen Gas

    Arm 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.

    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.

    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.

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    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.
    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

    Full Information

    First Posted
    May 17, 2017
    Last Updated
    May 22, 2017
    Sponsor
    Universidade Estadual Paulista Júlio de Mesquita Filho
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03165500
    Brief Title
    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

    2. Study Status

    Record Verification Date
    May 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    December 23, 2015 (Actual)
    Primary Completion Date
    December 20, 2016 (Actual)
    Study Completion Date
    May 4, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Universidade Estadual Paulista Júlio de Mesquita Filho

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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%.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Anxiety Disease
    Keywords
    Exodontia, Sedation, Nitrous Oxide, Benzodiazepines

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Early Phase 1
    Interventional Study Model
    Parallel Assignment
    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.
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    3 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Diazepam
    Arm Type
    Active Comparator
    Arm 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.
    Arm Title
    Midazolam
    Arm Type
    Active Comparator
    Arm 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.
    Arm Title
    Nitrous Oxide + Oxygen Gas
    Arm Type
    Active Comparator
    Arm 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.
    Intervention Type
    Drug
    Intervention Name(s)
    Diazepam
    Other Intervention Name(s)
    Valium, Diazepam 5mg
    Intervention Description
    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
    Intervention Name(s)
    Midazolam
    Other Intervention Name(s)
    Dormonid, Midazolam Oral Tablet
    Intervention Description
    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
    Intervention Name(s)
    Nitrous Oxide + Oxygen Gas
    Other Intervention Name(s)
    Nitrous Oxide, Nitrous Oxide Inhalant Product
    Intervention Description
    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
    Procedure
    Intervention Name(s)
    Third molar extraction
    Other Intervention Name(s)
    Third molar surgery
    Intervention Description
    Anxious patients in need of third molar extraction
    Primary Outcome Measure Information:
    Title
    Assessment of blood pressure change
    Description
    Evaluated in anxious patients submitted to the exodontia of third molars, sedated with diazepam, midazolam and nitrous oxide.The investigator evaluated with auscultatory instrument.
    Time Frame
    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 Outcome Measure Information:
    Title
    Assessment of heart rate change
    Description
    Evaluated in anxious patients submitted to the exodontia of third molars, sedated with diazepam, midazolam and nitrous oxide.The investigator evaluated with oscillometric monitor.
    Time Frame
    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
    Title
    Assessment of oxygen saturation change
    Description
    Evaluated in anxious patients submitted to the exodontia of third molars, sedated with diazepam, midazolam and nitrous oxide. The investigator evaluated with pulse oximeter
    Time Frame
    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 Pre-specified Outcome Measures:
    Title
    Retrograde amnesia
    Description
    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
    Time Frame
    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
    Title
    Test of Trieger
    Description
    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.
    Time Frame
    Measured 15 minutes after the end of surgery.]

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    30 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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)
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Michelle B Moraes, PHD
    Organizational Affiliation
    ICT-UNESP
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    27994412
    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.
    Results Reference
    result
    PubMed Identifier
    31377
    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.
    Results Reference
    result
    PubMed Identifier
    25488309
    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.
    Results Reference
    result

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    Comparative Evaluation of Three Anxiety Control Protocols in Third Molar Extraction

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