<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03838081</url>
  </required_header>
  <id_info>
    <org_study_id>36290600/69</org_study_id>
    <nct_id>NCT03838081</nct_id>
  </id_info>
  <brief_title>Evaluation on the Anxiety of Third Molar Extraction</brief_title>
  <official_title>Evaluation the Effect of Verbal &amp; Written Information and the Previous Surgical Experience on the Anxiety of Third Molar Extraction</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ankara University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ankara University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study was performed on 66 patients who were admitted for third molar extraction under&#xD;
      local anesthesia. The patients were divided into three groups: group 1 with verbal&#xD;
      information, group 2 with written information, and group 3 with previous surgical experience.&#xD;
      Spielberger State Anxiety Inventory (STAI-S), Dental Fear Scale (DFS), Modified Dental&#xD;
      Anxiety Scale (MDAS), and Visual Analog Scale (VAS) were used pre- and postoperatively to&#xD;
      evaluate dental anxiety&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This prospective study included 66 patients who underwent third molar extraction under local&#xD;
      anesthesia in the Oral and Maxillofacial Department, Faculty of Dentistry, Ankara University,&#xD;
      Turkey, between September and November 2018. The research protocol was approved by the&#xD;
      ethical committee of the institute (No: 36290600/69), Ankara University, Turkey.&#xD;
&#xD;
      Spielberger State Anxiety Inventory (STAI-S), Dental Fear Scale (DFS), Modified Dental&#xD;
      Anxiety Scale (MDAS), and Visual Analog Scale (VAS) are commonly used questionnaires for&#xD;
      dental anxiety. The latter asked only about age and sex. They were used together before and&#xD;
      immediately after surgery to obtain better results in this study.&#xD;
&#xD;
      After examining the panoramic radiographs, patients who underwent extraction were included in&#xD;
      Classes 1 and II, Positions A and B according to Pell-Gregory 16 classification, and&#xD;
      mesioangular and vertical positions according to the Winter 17 classification.&#xD;
&#xD;
      Each patient was examined by the researcher. The patients were informed about the procedure,&#xD;
      and written informed consent was obtained from the patient's preoperative assessment clinic.&#xD;
      If a patient had additional questions, they were included as part of the investigation.&#xD;
&#xD;
      The patients were divided into three groups:&#xD;
&#xD;
      Group 1: Patients who were given only basic information verbally Group 2: Patients with&#xD;
      detailed written information about preoperative, intraoperative, and postoperative periods&#xD;
      Group 3: Patients with previous experience and knowledge about third molar extraction&#xD;
      Previous experience was determined before giving the questionnaires. The patients were&#xD;
      randomly assigned to group 1 or 2 using an online random allocation software&#xD;
      (www.randomization.com). Information was provided on how to complete questionnaires. STAI-S,&#xD;
      MDAS, DFS, and VAS were applied to all patients 15 min before the surgery in the waiting&#xD;
      room. The demographic data section (age and sex) in the form was filled out by the&#xD;
      researcher.&#xD;
&#xD;
      The surgery was carried out under local anesthesia, with no pharmaceutical premedication or&#xD;
      sedation. The surgical procedures were performed by a single experienced surgeon in the oral&#xD;
      surgery clinic. After the surgery was completed, the patients were taken to the waiting room,&#xD;
      and prescribed medications were given. STAI-S, MDAS, DFS, and VAS were reapplied after the&#xD;
      surgery.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 15, 2018</start_date>
  <completion_date type="Actual">January 5, 2019</completion_date>
  <primary_completion_date type="Actual">December 15, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Evaluation of anxiety with Spielberger State Anxiety Inventory(STAI-S) between groups preoperatively and postoperatively</measure>
    <time_frame>2 minutes</time_frame>
    <description>Spielberger State Anxiety Inventory (STAI) is one of the most frequently used scales in anxiety research, although it is not a specific scale for dental anxiety. The inventory has 2 different scales, each with 20 items, showing the state and trait anxiety levels: STAI-state is used to determine a patient's current anxiety level, and STAI-trait is used to determine a patient's underlying (ongoing/personality) anxiety level. All 20 items are rated on a 4-point scale. The total score obtained can range from 20 to 80. STAI scores are commonly classified as &quot;no or low anxiety&quot; (20-37), &quot;moderate anxiety&quot; (38-44), and &quot;high anxiety&quot; (45-80). We used only STAI-S</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Evaluation of anxiety with Dental Fear Survey(DFS) between groups preoperatively and postoperatively</measure>
    <time_frame>2 minutes</time_frame>
    <description>DFS is a scale developed by Kleinknecht used to determine dental fear in different dimensions. This is a Likert-type scale with a score of 1-5. It has 20 items. It examines the level of fear in terms of dentist avoidance, somatic symptoms of fear, and fear of various applications in dentistry practice</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Evaluation of anxiety with Modified Dental Anxiety Scale(MDAS) between groups preoperatively and postoperatively</measure>
    <time_frame>1 minute</time_frame>
    <description>MDAS was developed by Humphris et al. by adding a question related to injection. The scale consists of five-point Likert-type rating with five options. The scoring in this scale varies between 5 and 25</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Evaluation of anxiety with Visual Analog Scale (VAS) between groups preoperatively and postoperatively</measure>
    <time_frame>1 minute</time_frame>
    <description>VAS is ideal for evaluating situations that cannot be measured using digital and oral information 25. In the present study, a scale comprising 100-mm closed-end line was used to measure the anxiety level. One end of the scale was labeled as &quot;no anxiety&quot; and the other end as &quot;maximum anxiety imaginable.&quot;</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">66</enrollment>
  <condition>Dental Anxiety</condition>
  <arm_group>
    <arm_group_label>Group 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Group 1: Patients who were given only basic information verbally</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Group 2: Patients with detailed written information about preoperative, intraoperative, and postoperative periods</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 3</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Group 3: Patients with previous experience and knowledge about third molar extraction</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Spielberger State Anxiety Inventory (STAI-S),</intervention_name>
    <description>STAI is one of the most frequently used scales in anxiety research, although it is not a specific scale for dental anxiety</description>
    <arm_group_label>Group 1</arm_group_label>
    <arm_group_label>Group 2</arm_group_label>
    <arm_group_label>Group 3</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Dental Fear Scale (DFS)</intervention_name>
    <description>DFS is a scale developed by Kleinknecht used to determine dental fear in different dimensions. This is a Likert-type scale with a score of 1-5. It has 20 items. It examines the level of fear in terms of dentist avoidance, somatic symptoms of fear, and fear of various applications in dentistry practice</description>
    <arm_group_label>Group 1</arm_group_label>
    <arm_group_label>Group 2</arm_group_label>
    <arm_group_label>Group 3</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Modified Dental Anxiety Scale (MDAS)</intervention_name>
    <description>MDAS was developed by Humphris et al. by adding a question related to injection. The scale consists of five-point Likert-type rating with five options. The scoring in this scale varies between 5 and 25</description>
    <arm_group_label>Group 1</arm_group_label>
    <arm_group_label>Group 2</arm_group_label>
    <arm_group_label>Group 3</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Visual Analog Scale (VAS)</intervention_name>
    <description>VAS is ideal for evaluating situations that cannot be measured using digital and oral information. In the present study, a scale comprising 100-mm closed-end line was used to measure the anxiety level. One end of the scale was labeled as &quot;no anxiety&quot; and the other end as &quot;maximum anxiety imaginable</description>
    <arm_group_label>Group 1</arm_group_label>
    <arm_group_label>Group 2</arm_group_label>
    <arm_group_label>Group 3</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adults aged 18-80 years&#xD;
&#xD;
          -  American Society of Anesthesiologists physical status score I and II&#xD;
&#xD;
          -  Patients without any systemic disease, or regular medication use.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  İnability to read and understand Turkish&#xD;
&#xD;
          -  Significantly impaired eyesight or hearing, an existing psychiatric disorder&#xD;
&#xD;
          -  Patients aged less than 18 years&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kevser Sancak</last_name>
    <role>Study Chair</role>
    <affiliation>Ankara University Faculty of Dentısry</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Ankara University dentisry of faculty</name>
      <address>
        <city>Ankara</city>
        <zip>06500</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <reference>
    <citation>Muglali M, Komerik N. Factors related to patients' anxiety before and after oral surgery. J Oral Maxillofac Surg. 2008 May;66(5):870-7. doi: 10.1016/j.joms.2007.06.662.</citation>
    <PMID>18423273</PMID>
  </reference>
  <reference>
    <citation>Jaakkola S, Rautava P, Alanen P, Aromaa M, Pienihakkinen K, Raiha H, Vahlberg T, Mattila ML, Sillanpaa M. Dental fear: one single clinical question for measurement. Open Dent J. 2009 Jul 28;3:161-6. doi: 10.2174/1874210600903010161.</citation>
    <PMID>19672334</PMID>
  </reference>
  <reference>
    <citation>Pell GJ. Impacted mandibular third molars: classification and modified techniques for removal. Dent Digest. 1933;39:330-338.</citation>
  </reference>
  <reference>
    <citation>Winter GB. Principles of exodontia as applied to the impacted mandibular third molar. American Medical Book Company; 1926.</citation>
  </reference>
  <reference>
    <citation>Ost L-g, Öst L-G, Skaret E. Cognitive behavioral therapy for dental phobia and anxiety. John Wiley &amp; Sons; 2013</citation>
  </reference>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>February 10, 2019</study_first_submitted>
  <study_first_submitted_qc>February 10, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 12, 2019</study_first_posted>
  <last_update_submitted>February 13, 2019</last_update_submitted>
  <last_update_submitted_qc>February 13, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 15, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ankara University</investigator_affiliation>
    <investigator_full_name>Kevser Sancak</investigator_full_name>
    <investigator_title>Oral and Maxillofacial surgery, Principal investigator</investigator_title>
  </responsible_party>
  <keyword>third molar extraction</keyword>
  <keyword>Preoperative anxiety</keyword>
  <keyword>Dental Anxiety</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anxiety Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03838081
org study id: 36290600/69
nct id: NCT03838081
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study was performed on 66 patients who were admitted for third molar extraction under
      local anesthesia. The patients were divided into three groups: group 1 with verbal
      information, group 2 with written information, and group 3 with previous surgical experience.
      Spielberger State Anxiety Inventory (STAI-S), Dental Fear Scale (DFS), Modified Dental
      Anxiety Scale (MDAS), and Visual Analog Scale (VAS) were used pre- and postoperatively to
      evaluate dental anxiety
This prospective study included 66 patients who underwent third molar extraction under local
      anesthesia in the Oral and Maxillofacial Department, Faculty of Dentistry, Ankara University,
      Turkey, between September and November 2018. The research protocol was approved by the
      ethical committee of the institute (No: 36290600/69), Ankara University, Turkey.

      Spielberger State Anxiety Inventory (STAI-S), Dental Fear Scale (DFS), Modified Dental
      Anxiety Scale (MDAS), and Visual Analog Scale (VAS) are commonly used questionnaires for
      dental anxiety. The latter asked only about age and sex. They were used together before and
      immediately after surgery to obtain better results in this study.

      After examining the panoramic radiographs, patients who underwent extraction were included in
      Classes 1 and II, Positions A and B according to Pell-Gregory 16 classification, and
      mesioangular and vertical positions according to the Winter 17 classification.

      Each patient was examined by the researcher. The patients were informed about the procedure,
      and written informed consent was obtained from the patient's preoperative assessment clinic.
      If a patient had additional questions, they were included as part of the investigation.

      The patients were divided into three groups:

      Group 1: Patients who were given only basic information verbally Group 2: Patients with
      detailed written information about preoperative, intraoperative, and postoperative periods
      Group 3: Patients with previous experience and knowledge about third molar extraction
      Previous experience was determined before giving the questionnaires. The patients were
      randomly assigned to group 1 or 2 using an online random allocation software
      (www.randomization.com). Information was provided on how to complete questionnaires. STAI-S,
      MDAS, DFS, and VAS were applied to all patients 15 min before the surgery in the waiting
      room. The demographic data section (age and sex) in the form was filled out by the
      researcher.

      The surgery was carried out under local anesthesia, with no pharmaceutical premedication or
      sedation. The surgical procedures were performed by a single experienced surgeon in the oral
      surgery clinic. After the surgery was completed, the patients were taken to the waiting room,
      and prescribed medications were given. STAI-S, MDAS, DFS, and VAS were reapplied after the
      surgery.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Single (Investigator)
measure: Evaluation of anxiety with Spielberger State Anxiety Inventory(STAI-S) between groups preoperatively and postoperatively
time frame: 2 minutes
description: Spielberger State Anxiety Inventory (STAI) is one of the most frequently used scales in anxiety research, although it is not a specific scale for dental anxiety. The inventory has 2 different scales, each with 20 items, showing the state and trait anxiety levels: STAI-state is used to determine a patient's current anxiety level, and STAI-trait is used to determine a patient's underlying (ongoing/personality) anxiety level. All 20 items are rated on a 4-point scale. The total score obtained can range from 20 to 80. STAI scores are commonly classified as "no or low anxiety" (20-37), "moderate anxiety" (38-44), and "high anxiety" (45-80). We used only STAI-S
measure: Evaluation of anxiety with Dental Fear Survey(DFS) between groups preoperatively and postoperatively
time frame: 2 minutes
description: DFS is a scale developed by Kleinknecht used to determine dental fear in different dimensions. This is a Likert-type scale with a score of 1-5. It has 20 items. It examines the level of fear in terms of dentist avoidance, somatic symptoms of fear, and fear of various applications in dentistry practice
measure: Evaluation of anxiety with Modified Dental Anxiety Scale(MDAS) between groups preoperatively and postoperatively
time frame: 1 minute
description: MDAS was developed by Humphris et al. by adding a question related to injection. The scale consists of five-point Likert-type rating with five options. The scoring in this scale varies between 5 and 25
measure: Evaluation of anxiety with Visual Analog Scale (VAS) between groups preoperatively and postoperatively
time frame: 1 minute
description: VAS is ideal for evaluating situations that cannot be measured using digital and oral information 25. In the present study, a scale comprising 100-mm closed-end line was used to measure the anxiety level. One end of the scale was labeled as "no anxiety" and the other end as "maximum anxiety imaginable."
arm group label: Group 1
arm group type: Experimental
description: Group 1: Patients who were given only basic information verbally
arm group label: Group 2
arm group type: Experimental
description: Group 2: Patients with detailed written information about preoperative, intraoperative, and postoperative periods
arm group label: Group 3
arm group type: Experimental
description: Group 3: Patients with previous experience and knowledge about third molar extraction
intervention type: Behavioral
intervention name: Spielberger State Anxiety Inventory (STAI-S),
description: STAI is one of the most frequently used scales in anxiety research, although it is not a specific scale for dental anxiety
arm group label: Group 1
arm group label: Group 2
arm group label: Group 3
intervention type: Behavioral
intervention name: Dental Fear Scale (DFS)
description: DFS is a scale developed by Kleinknecht used to determine dental fear in different dimensions. This is a Likert-type scale with a score of 1-5. It has 20 items. It examines the level of fear in terms of dentist avoidance, somatic symptoms of fear, and fear of various applications in dentistry practice
arm group label: Group 1
arm group label: Group 2
arm group label: Group 3
intervention type: Behavioral
intervention name: Modified Dental Anxiety Scale (MDAS)
description: MDAS was developed by Humphris et al. by adding a question related to injection. The scale consists of five-point Likert-type rating with five options. The scoring in this scale varies between 5 and 25
arm group label: Group 1
arm group label: Group 2
arm group label: Group 3
intervention type: Behavioral
intervention name: Visual Analog Scale (VAS)
description: VAS is ideal for evaluating situations that cannot be measured using digital and oral information. In the present study, a scale comprising 100-mm closed-end line was used to measure the anxiety level. One end of the scale was labeled as "no anxiety" and the other end as "maximum anxiety imaginable
arm group label: Group 1
arm group label: Group 2
arm group label: Group 3
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Kevser Sancak
role: Study Chair
affiliation: Ankara University Faculty of Dentısry
facility: 
country: Turkey
citation: Muglali M, Komerik N. Factors related to patients' anxiety before and after oral surgery. J Oral Maxillofac Surg. 2008 May;66(5):870-7. doi: 10.1016/j.joms.2007.06.662.
PMID: 18423273
citation: Jaakkola S, Rautava P, Alanen P, Aromaa M, Pienihakkinen K, Raiha H, Vahlberg T, Mattila ML, Sillanpaa M. Dental fear: one single clinical question for measurement. Open Dent J. 2009 Jul 28;3:161-6. doi: 10.2174/1874210600903010161.
PMID: 19672334
citation: Pell GJ. Impacted mandibular third molars: classification and modified techniques for removal. Dent Digest. 1933;39:330-338.
citation: Winter GB. Principles of exodontia as applied to the impacted mandibular third molar. American Medical Book Company; 1926.
citation: Ost L-g, Öst L-G, Skaret E. Cognitive behavioral therapy for dental phobia and anxiety. John Wiley & Sons; 2013
responsible party type: Principal Investigator
investigator affiliation: Ankara University
investigator full name: Kevser Sancak
investigator title: Oral and Maxillofacial surgery, Principal investigator
mesh term: Anxiety Disorders
sharing ipd: No