Effects of Consent Methods Performed According to Intelligence Types on Anxiety Associated With Third Molar Surgery

Dental Anxiety Clinical Trial

Official title:

Investigation of the Effects of Consent Methods Performed According to Intelligence Types on Anxiety Associated With Third Molar Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04613947
• Other study ID #: 2020/192
• Status: Completed
• Phase: N/A
• Start date: October 1, 2020
• Est. completion date: June 30, 2021

Study information

• Verified date: December 2022
• Source: T.C. ORDU ÜNIVERSITESI
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to investigate the effect of information provided in accordance with intelligence type on anxiety associated with wisdom tooth surgery.

Description:

The participants who will undergo third molar surgery divided into study and control groups. Study group divided further into three groups according to multiple intellegence test. Ultimately four groups created as follows; 1. Control: The group with standard (written and verbal) information without multiple intelligence test 2. Visual/Spatial: The group with higher visual intelligence according to the multiple intelligence test results and watch video. Also, will given with a written informed consent document. 3. Verbal/Linguistic: The group with higher verbal/linguistic intelligence according to the multiple intelligence test results and verbally informed in detail about the operation. lso, will given with a written informed consent document 4. Bodily/Kinesthetic: The group with higher bodily/kinesthetic intelligence according to the multiple intelligence test results and informed with a dental model. lso, will given with a written informed consent document To evaluate anxiety; participants will asked to complete MDAS questionnairre before and after consent, and after operation. Also, saliva samples will obtained to evaluate the salivary cortisol before and after consent, and after operation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: June 30, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• Patients with mandibular third molar tooth in vertical or mesioangular position according to Winter classification, class I and II ramus relationship according to Pell-Gregory classification and class B and C depth
• Patients who maintain their normal sleep patterns,
• Patients with ASA I status according to the American Society of Anesthesiologists (ASA) classification.

Exclusion Criteria:

• Patients did not agree to be a volunteer, and/or refused to watch videos or receive information in a different way from the standard procedure,
• Habits of Smoking and alcohol
• Patients who are pregnant or in the lactation period,
• Patients unable to cooperate,
• Patients having a psychiatric illness,
• Patients with systemic disease (local or systemic factors affecting salivary gland function, can cause changes in endocrine response)
• Patients using chronic medication and drugs that affect salivary cortisol levels, such as androgens, estrogens and corticosteroids.
• Patients with pericoronitis

Related Conditions & MeSH terms

• Anxiety Disorders
• Dental Anxiety

Intervention

Behavioral:
• Informed consent
The style of informing patients about the procedure they will undergo

Procedure:
• Third molar surgery
Surgical extraction of the third molar tooth

Locations

Country	Name	City	State
Turkey	Ordu University	Ordu

Sponsors (1)

Lead Sponsor	Collaborator
T.C. ORDU ÜNIVERSITESI

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dental anxiety	Anxiety change being assessed with Modified Dental Anxiety Scale (MDAS) MDAS consists of five questions in total which measures anxiety at different stages of dental treatment. 1 (no anxious) to 5 (very anxious) options are available for each question. The sum of the scores varies from 5 to 25 and the values between 19-25 indicates high dental anxiety.	at operation day (before and after operation and immediately after consent)
Secondary	Salivary cortisol level	The amount of cortisol in saliva samples	at operation day (before and after operation and immediately after consent)