Evaluation on the Anxiety of Third Molar Extraction

NCT ID: NCT03838081

Last Updated: 2019-02-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-15

Study Completion Date

2019-01-05

Brief Summary

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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

Detailed Description

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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.

Conditions

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Dental Anxiety

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Investigators

Study Groups

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Group 1

Group 1: Patients who were given only basic information verbally

Group Type EXPERIMENTAL

Spielberger State Anxiety Inventory (STAI-S),

Intervention Type BEHAVIORAL

STAI is one of the most frequently used scales in anxiety research, although it is not a specific scale for dental anxiety

Dental Fear Scale (DFS)

Intervention Type BEHAVIORAL

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

Modified Dental Anxiety Scale (MDAS)

Intervention Type BEHAVIORAL

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

Visual Analog Scale (VAS)

Intervention Type BEHAVIORAL

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

Group 2

Group 2: Patients with detailed written information about preoperative, intraoperative, and postoperative periods

Group Type EXPERIMENTAL

Spielberger State Anxiety Inventory (STAI-S),

Intervention Type BEHAVIORAL

STAI is one of the most frequently used scales in anxiety research, although it is not a specific scale for dental anxiety

Dental Fear Scale (DFS)

Intervention Type BEHAVIORAL

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

Modified Dental Anxiety Scale (MDAS)

Intervention Type BEHAVIORAL

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

Visual Analog Scale (VAS)

Intervention Type BEHAVIORAL

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

Group 3

Group 3: Patients with previous experience and knowledge about third molar extraction

Group Type EXPERIMENTAL

Spielberger State Anxiety Inventory (STAI-S),

Intervention Type BEHAVIORAL

STAI is one of the most frequently used scales in anxiety research, although it is not a specific scale for dental anxiety

Dental Fear Scale (DFS)

Intervention Type BEHAVIORAL

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

Modified Dental Anxiety Scale (MDAS)

Intervention Type BEHAVIORAL

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

Visual Analog Scale (VAS)

Intervention Type BEHAVIORAL

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

Interventions

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Spielberger State Anxiety Inventory (STAI-S),

STAI is one of the most frequently used scales in anxiety research, although it is not a specific scale for dental anxiety

Intervention Type BEHAVIORAL

Dental Fear Scale (DFS)

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

Intervention Type BEHAVIORAL

Modified Dental Anxiety Scale (MDAS)

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

Intervention Type BEHAVIORAL

Visual Analog Scale (VAS)

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ankara University

OTHER

Sponsor Role lead

Responsible Party

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Kevser Sancak

Oral and Maxillofacial surgery, Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kevser Sancak

Role: STUDY_CHAIR

Ankara University Faculty of Dentısry

Locations

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Ankara University dentisry of faculty

Ankara, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 18423273 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19672334 (View on PubMed)

Pell GJ. Impacted mandibular third molars: classification and modified techniques for removal. Dent Digest. 1933;39:330-338.

Reference Type BACKGROUND

Winter GB. Principles of exodontia as applied to the impacted mandibular third molar. American Medical Book Company; 1926.

Reference Type BACKGROUND

Ost L-g, Öst L-G, Skaret E. Cognitive behavioral therapy for dental phobia and anxiety. John Wiley & Sons; 2013

Reference Type BACKGROUND

Other Identifiers

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36290600/69

Identifier Type: -

Identifier Source: org_study_id

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