Impacted Third Molar ToothNCT05548790
Should Preoperative Information Before Impacted Third Molar Extraction?
A study testing Spielberger State Anxiety Inventory (STAI-S), Dental Fear Scale (DFS) and Modified Dental Anxiety Scale (MDAS) in people with Impacted Third Molar Tooth and Dental Anxiety, run by Ankara Yildirim Beyazıt University at 1 site in Turkey (Türkiye).
Trial summary
The main objective of the present study was to evaluate the effects of different preoperative information techniques (verbal, written, video with background audio, and silent video with subtitles) on patients' anxiety levels before and after third molar extraction. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Impacted Third Molar Tooth, Dental Anxiety
- What is being tested?
- Spielberger State Anxiety Inventory (STAI-S), Dental Fear Scale (DFS) and Modified Dental Anxiety Scale (MDAS)
- Type of treatment
- Pill or oral medicine, Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2022to 30 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients who did not have pain
- Signs of infection related to the third molar were included
- American Society of Anesthesiologists physical status score I and II
- The absence of any systemic disease and regular medication use
Who cannot join
- Patients have the presence of an existing psychiatric disorder, psychiatric disorders, anxiolytic or antidepressant drug treatment
- Patients who were pregnant or lactated
- Patients who couldn't understand or fill out questionnaires, had presence of visual or auditory deficits, refuse to watch the video or join the study, had incomplete data
- Patients who had a previous negative experience with dental treatment were excluded from the study, as it may cause higher anxiety levels
- Those who watched a video on the subject before were not included in the study
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Yıldırım beyazıt University, Faculty of Dentistry
Ankara, 06790
About this study
Official title: Should Preoperative Information Before Impacted Third Molar Extraction Be Visual, Verbal or Both?
The main objective of the present study was to evaluate the effects of different preoperative information techniques (verbal, written, video with background audio, and silent video with subtitles) on patients' anxiety levels before and after third molar extraction. The secondary objective was to determine the superiority of the information methods evaluated over each other. We hypothesized that the information provided by video with or without background audio would decrease preoperative and postoperative anxiety levels more effectively than information provided by verbal and written methods.
Read the detailed description
This prospective study included 86 patients who underwent third molar extraction under local anesthesia in the Oral and Maxillofacial Department, Faculty of Dentistry, Ankara Yıldırım Beyazıt University, Turkey, between May and June 2022. The research protocol was approved by The Yıldırım Beyazıt University Oral and Health Training and Research Hospital Ethical Committee,Turkey. (No: E-2022-14) 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 classification, and mesioangular and vertical positions according to the Winter 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 Patients were assigned to 4 groups: Group 1 was informed via silent video with subtitle, group 2 was informed via video with background audio, group 3 was informed with written information brochure, group 4 (control group) was informed preoperatively verbally. The 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 the dental anxiety of patients
- Conditions
- Impacted Third Molar Tooth, Dental Anxiety
- Being tested
- Spielberger State Anxiety Inventory (STAI-S), Dental Fear Scale (DFS), Modified Dental Anxiety Scale (MDAS), Visual Analog Scale (VAS)
- Keywords
- third molar extraction, Dental anxiety, preoperative information
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spielberger State Anxiety Inventory (STAI-S)Behavioural
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)Behavioural
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)Behavioural
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)Behavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Group 1: patients were given information via silent video with subtitle (5-minute) Receives: 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 were given information via video with background audio (5-minute 34-second) Receives: 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 were given written information brochure Receives: Behavioral: Spielberger State Anxiety Inventory (STAI-S); Behavioral: Dental Fear Scale (DFS); Behavioral: Modified Dental Anxiety Scale (MDAS); Behavioral: Visual Analog Scale (VAS) |
| Group 4 | Experimental | Group 4: patients were given information verbally Receives: Behavioral: Spielberger State Anxiety Inventory (STAI-S); Behavioral: Dental Fear Scale (DFS); Behavioral: Modified Dental Anxiety Scale (MDAS); Behavioral: Visual Analog Scale (VAS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of anxiety with Spielberger State Anxiety Inventory(STAI-S) between groups preoperatively and postoperatively
STAI-S is a 20-item scale that determines the current anxiety level of the patient with reliability and validity in Turkish. Widely used to assess anxiety, the STAI explores the transient state of anxiety, and patients report how they are feeling at the current time point. It is scored using a 4-level frequency scale ranging from 0 to 3. The total score ranges from 20 to 80, higher scores indicates higher anxiety
Measured: 2 minutes
Evaluation of anxiety with Dental Fear Survey(DFS) between groups preoperatively and postoperatively
DFS is which consists of 20-items is used to determine physiological responses to dental stimuli via a Likert-type scale ranging from 1 to 5. Total scores change from 20 to 100 point. It collects the evaluation of dental anxiety under 3 headings. The first 2 questions assess avoidance of dentistry, questions 3-7 show physiological arousal, and questions 8-20 predict fear of certain situations
Measured: 2 minutes
Evaluation of anxiety with Modified Dental Anxiety Scale(MDAS) between groups preoperatively and postoperatively
MDAS which is created by adding one question to the Corah Dental Anxiety Scale have 5-item questionnaire with 5-point Likert-type scale. Scale shows points between 5 and 25
Measured: 1 minute
Evaluation of anxiety with Visual Analog Scale (VAS) between groups preoperatively and postoperatively
VAS is a digital and verbal assessment scale used to measure anxiety. A closed-ended scale of 0-100 mm ("0" no anxiety, "100" maximum imaginable anxiety) was used in the study, and participants were asked to put a mark on the VAS scale, which they thought showed the degree of their current anxiety
Measured: 1 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2022
- Study start1 May 2022
- Primary completion30 Jun 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Impacted Third Molar ToothStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Group 1 was informed via silent video with subtitle, group 2 was informed via video with background audio, group 3 was informed with written information brochure, group 4 (control group) was informed verbally.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara Yildirim Beyazıt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kevser SANCAK, Ankara Yildirim Beyazıt University
- Investigators
- kevser sancak, Principal investigator, Ankara Yıldırım Beyazıt University Faculty of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05548790
- Sponsor's protocol ID
- E-2022-14
- Status last verified
- Sep 2022
- First submitted
- 9 Sep 2022
- Last updated
- 21 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 18423273Laskin DM, Priest JH, Alfaqih S, Carrico CK. Does Viewing a Third Molar Informed Consent Video Decrease Patients' Anxiety? J Oral Maxillofac Surg. 2018 Dec;76(12):2515-2517. doi: 10.1016/j.joms.2018.08.001. Epub 2018 Aug 15.
PubMed 30193118Sirin Y, Humphris G, Sencan S, Firat D. What is the most fearful intervention in ambulatory oral surgery? Analysis of an outpatient clinic. Int J Oral Maxillofac Surg. 2012 Oct;41(10):1284-90. doi: 10.1016/j.ijom.2012.06.013. Epub 2012 Jul 23.
PubMed 22832662de Jongh A, Olff M, van Hoolwerff H, Aartman IH, Broekman B, Lindauer R, Boer F. Anxiety and post-traumatic stress symptoms following wisdom tooth removal. Behav Res Ther. 2008 Dec;46(12):1305-10. doi: 10.1016/j.brat.2008.09.004. Epub 2008 Sep 25.
PubMed 18954863
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Should Preoperative Information Before Impacted Third Molar Extraction Be Visual, Verbal or Both?
- ClinicalTrials.gov ID
- NCT05548790
- Acronym / sponsor ID
- E-2022-14
- Conditions
- Impacted Third Molar Tooth, Dental Anxiety
- Keywords
- third molar extraction, Dental anxiety, preoperative information
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Ankara Yildirim Beyazıt UniversityUniversity, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 21 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main objective of the present study was to evaluate the effects of different preoperative information techniques (verbal, written, video with background audio, and silent video with subtitles) on patients' anxiety levels before and after third molar extraction. The secondary objective was to determine the superiority of the information methods evaluated over each other. We hypothesized that the information provided by video with or without background audio would decrease preoperative and postoperative anxiety levels more effectively than information provided by verbal and written methods.
Detailed description
This prospective study included 86 patients who underwent third molar extraction under local anesthesia in the Oral and Maxillofacial Department, Faculty of Dentistry, Ankara Yıldırım Beyazıt University, Turkey, between May and June 2022. The research protocol was approved by The Yıldırım Beyazıt University Oral and Health Training and Research Hospital Ethical Committee,Turkey. (No: E-2022-14) 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 classification, and mesioangular and vertical positions according to the Winter 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 Patients were assigned to 4 groups: Group 1 was informed via silent video with subtitle, group 2 was informed via video with background audio, group 3 was informed with written information brochure, group 4 (control group) was informed preoperatively verbally. The 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 the dental anxiety of patients
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
- Model description
- Group 1 was informed via silent video with subtitle, group 2 was informed via video with background audio, group 3 was informed with written information brochure, group 4 (control group) was informed verbally.
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Behavioral: Spielberger State Anxiety Inventory (STAI-S), Behavioral: Dental Fear Scale (DFS), Behavioral: Modified Dental Anxiety Scale (MDAS), Behavioral: Visual Analog Scale (VAS)Group 1: patients were given information via silent video with subtitle (5-minute) |
| Group 2 | Experimental | 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: patients were given information via video with background audio (5-minute 34-second) |
| Group 3 | Experimental | 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: patients were given written information brochure |
| Group 4 | Experimental | Behavioral: Spielberger State Anxiety Inventory (STAI-S), Behavioral: Dental Fear Scale (DFS), Behavioral: Modified Dental Anxiety Scale (MDAS), Behavioral: Visual Analog Scale (VAS)Group 4: patients were given information verbally |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients who did not have pain
- Signs of infection related to the third molar were included
- American Society of Anesthesiologists physical status score I and II
- The absence of any systemic disease and regular medication use
Key exclusion criteria (5 listed)
- Patients have the presence of an existing psychiatric disorder, psychiatric disorders, anxiolytic or antidepressant drug treatment
- Patients who were pregnant or lactated
- Patients who couldn't understand or fill out questionnaires, had presence of visual or auditory deficits, refuse to watch the video or join the study, had incomplete data
- Patients who had a previous negative experience with dental treatment were excluded from the study, as it may cause higher anxiety levels
- Those who watched a video on the subject before were not included in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Behavioural | Group 1, Group 2, Group 3, Group 4 |
| 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 | Behavioural | Group 1, Group 2, Group 3, Group 4 |
| 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 | Behavioural | Group 1, Group 2, Group 3, Group 4 |
| 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 | Behavioural | Group 1, Group 2, Group 3, Group 4 |
Primary outcome
Evaluation of anxiety with Spielberger State Anxiety Inventory(STAI-S) between groups preoperatively and postoperatively
Time frame: 2 minutes
STAI-S is a 20-item scale that determines the current anxiety level of the patient with reliability and validity in Turkish. Widely used to assess anxiety, the STAI explores the transient state of anxiety, and patients report how they are feeling at the current time point. It is scored using a 4-level frequency scale ranging from 0 to 3. The total score ranges from 20 to 80, higher scores indicates higher anxiety
Evaluation of anxiety with Dental Fear Survey(DFS) between groups preoperatively and postoperatively
Time frame: 2 minutes
DFS is which consists of 20-items is used to determine physiological responses to dental stimuli via a Likert-type scale ranging from 1 to 5. Total scores change from 20 to 100 point. It collects the evaluation of dental anxiety under 3 headings. The first 2 questions assess avoidance of dentistry, questions 3-7 show physiological arousal, and questions 8-20 predict fear of certain situations
Evaluation of anxiety with Modified Dental Anxiety Scale(MDAS) between groups preoperatively and postoperatively
Time frame: 1 minute
MDAS which is created by adding one question to the Corah Dental Anxiety Scale have 5-item questionnaire with 5-point Likert-type scale. Scale shows points between 5 and 25
Evaluation of anxiety with Visual Analog Scale (VAS) between groups preoperatively and postoperatively
Time frame: 1 minute
VAS is a digital and verbal assessment scale used to measure anxiety. A closed-ended scale of 0-100 mm ("0" no anxiety, "100" maximum imaginable anxiety) was used in the study, and participants were asked to put a mark on the VAS scale, which they thought showed the degree of their current anxiety
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2022.
- Background: PubMed 18423273Muglali 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.
- Background: PubMed 30193118Laskin DM, Priest JH, Alfaqih S, Carrico CK. Does Viewing a Third Molar Informed Consent Video Decrease Patients' Anxiety? J Oral Maxillofac Surg. 2018 Dec;76(12):2515-2517. doi: 10.1016/j.joms.2018.08.001. Epub 2018 Aug 15.
- Background: PubMed 22832662Sirin Y, Humphris G, Sencan S, Firat D. What is the most fearful intervention in ambulatory oral surgery? Analysis of an outpatient clinic. Int J Oral Maxillofac Surg. 2012 Oct;41(10):1284-90. doi: 10.1016/j.ijom.2012.06.013. Epub 2012 Jul 23.
- Background: PubMed 18954863de Jongh A, Olff M, van Hoolwerff H, Aartman IH, Broekman B, Lindauer R, Boer F. Anxiety and post-traumatic stress symptoms following wisdom tooth removal. Behav Res Ther. 2008 Dec;46(12):1305-10. doi: 10.1016/j.brat.2008.09.004. Epub 2008 Sep 25.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
kevser sancak principal investigator
Ankara Yıldırım Beyazıt University Faculty of Dentistry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spielberger State Anxiety Inventory (STAI-S), Dental Fear Scale (DFS) and Modified Dental Anxiety Scale (MDAS) in people with Impacted Third Molar Tooth and Dental Anxiety, run by Ankara Yildirim Beyazıt University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of anxiety with Spielberger State Anxiety Inventory(STAI-S) between groups preoperatively and postoperatively (time frame: 2 minutes). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05548790, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2022.