NCT03838081

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 15, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2018

Completed
21 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 5, 2019

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 10, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 12, 2019

Completed
Last Updated

February 15, 2019

Status Verified

February 1, 2019

Enrollment Period

3 months

First QC Date

February 10, 2019

Last Update Submit

February 13, 2019

Conditions

Keywords

third molar extractionPreoperative anxietyDental Anxiety

Outcome Measures

Primary Outcomes (4)

  • Evaluation of anxiety with Spielberger State Anxiety Inventory(STAI-S) between groups preoperatively and postoperatively

    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

    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

    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

    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

Study Arms (3)

Group 1

EXPERIMENTAL

Group 1: Patients who were given only basic information verbally

Behavioral: Spielberger State Anxiety Inventory (STAI-S),Behavioral: Dental Fear Scale (DFS)Behavioral: Modified Dental Anxiety Scale (MDAS)Behavioral: Visual Analog Scale (VAS)

Group 2

EXPERIMENTAL

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

Behavioral: Spielberger State Anxiety Inventory (STAI-S),Behavioral: Dental Fear Scale (DFS)Behavioral: Modified Dental Anxiety Scale (MDAS)Behavioral: Visual Analog Scale (VAS)

Group 3

EXPERIMENTAL

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

Behavioral: Spielberger State Anxiety Inventory (STAI-S),Behavioral: Dental Fear Scale (DFS)Behavioral: Modified Dental Anxiety Scale (MDAS)Behavioral: Visual Analog Scale (VAS)

Interventions

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

Group 1Group 2Group 3

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

Group 1Group 2Group 3

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

Group 1Group 2Group 3

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 1Group 2Group 3

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults aged 18-80 years
  • American Society of Anesthesiologists physical status score I and II
  • Patients without any systemic disease, or regular medication use.

You may not qualify if:

  • İnability to read and understand Turkish
  • Significantly impaired eyesight or hearing, an existing psychiatric disorder
  • Patients aged less than 18 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara University dentisry of faculty

Ankara, 06500, Turkey (Türkiye)

Location

Related Publications (5)

  • 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: 18423273BACKGROUND
  • 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: 19672334BACKGROUND
  • Pell GJ. Impacted mandibular third molars: classification and modified techniques for removal. Dent Digest. 1933;39:330-338.

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

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

    BACKGROUND

Study Officials

  • Kevser Sancak

    Ankara University Faculty of Dentısry

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Oral and Maxillofacial surgery, Principal investigator

Study Record Dates

First Submitted

February 10, 2019

First Posted

February 12, 2019

Study Start

September 15, 2018

Primary Completion

December 15, 2018

Study Completion

January 5, 2019

Last Updated

February 15, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will not share

Locations