- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03838081
Evaluation on the Anxiety of Third Molar Extraction
Evaluation the Effect of Verbal & Written Information and the Previous Surgical Experience on the Anxiety of Third Molar Extraction
Study Overview
Status
Conditions
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Ankara, Turkey, 06500
- Ankara University dentisry of faculty
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Adults aged 18-80 years
- American Society of Anesthesiologists physical status score I and II
- Patients without any systemic disease, or regular medication use.
Exclusion Criteria:
- İnability to read and understand Turkish
- Significantly impaired eyesight or hearing, an existing psychiatric disorder
- Patients aged less than 18 years
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Group 1
Group 1: Patients who were given only basic information verbally
|
STAI is one of the most frequently used scales in anxiety research, although it is not a specific scale for dental anxiety
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
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
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
|
Experimental: Group 2
Group 2: Patients with detailed written information about preoperative, intraoperative, and postoperative periods
|
STAI is one of the most frequently used scales in anxiety research, although it is not a specific scale for dental anxiety
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
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
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
|
Experimental: Group 3
Group 3: Patients with previous experience and knowledge about third molar extraction
|
STAI is one of the most frequently used scales in anxiety research, although it is not a specific scale for dental anxiety
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
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
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Evaluation of anxiety with Spielberger State Anxiety Inventory(STAI-S) between groups preoperatively and postoperatively
Time Frame: 2 minutes
|
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
|
2 minutes
|
Evaluation of anxiety with Dental Fear Survey(DFS) between groups preoperatively and postoperatively
Time Frame: 2 minutes
|
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
|
2 minutes
|
Evaluation of anxiety with Modified Dental Anxiety Scale(MDAS) between groups preoperatively and postoperatively
Time Frame: 1 minute
|
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
|
1 minute
|
Evaluation of anxiety with Visual Analog Scale (VAS) between groups preoperatively and postoperatively
Time Frame: 1 minute
|
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."
|
1 minute
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Kevser Sancak, Ankara University Faculty of Dentısry
Publications and helpful links
General Publications
- 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.
- 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.
- Pell GJ. Impacted mandibular third molars: classification and modified techniques for removal. Dent Digest. 1933;39:330-338.
- Winter GB. Principles of exodontia as applied to the impacted mandibular third molar. American Medical Book Company; 1926.
- Ost L-g, Öst L-G, Skaret E. Cognitive behavioral therapy for dental phobia and anxiety. John Wiley & Sons; 2013
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 36290600/69
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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