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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05038540
Other study ID # 00
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 8, 2021
Est. completion date December 23, 2021

Study information

Verified date July 2023
Source Kutahya Health Sciences University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

In this clinical study, it was aimed to evaluate whether there is a decrease in patient anxiety by applying virtual reality glasses, which are the product of new technology, during scaling and root planing treatment. Patients who required scaling and root planing treatment and also scored 9 or above according to the Dental Anxiety Scale were included in our study. Scaling and root planing was performed in a randomly selected intraoral quadrant of the patients, in the same way, with or without the use of virtual reality glasses. In the virtual reality glasses application, a video consisting of images of nature landscapes developed for patient rehabilitation was projected onto the screen in front of the patient's eyes. The Dental Anxiety Scale was reapplied after the completion of the treatment. In the intraoral quadrant where virtual reality glasses were used, it is expected that lower Corah Dental Anxiety Scale scores may be obtained after the treatment is completed, compared to the intraoral quadrant where the treatment is performed without glasses, thus reducing anxiety.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date December 23, 2021
Est. primary completion date November 23, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 59 Years
Eligibility Inclusion Criteria: - Being over 18 years old - Being systemically healthy - Needing treatment in at least two quadrants of the mouth - At least five teeth in each quadrant and at least one region with a terminal pocket depth =4 mm - Having a score of 9 or higher on the dental anxiety scale Exclusion Criteria: - Having a history of seizures or a convulsive disorder - Balance disorders such as nystagmus, vertigo - Use of psychotropic drugs - Getting treatment for anxiety - Presence of dermatological lesions on the face and especially around the eyes - The presence of a lesion in the eye that will prevent the use of virtual reality glasses

Study Design


Intervention

Procedure:
Scaling and root planing
Phase 1 periodontal therapy

Locations

Country Name City State
Turkey Kutahya Health Sciences University Kütahya

Sponsors (1)

Lead Sponsor Collaborator
Kutahya Health Sciences University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Lower Corah Dental Anxiety Scale scores in virtual reality application group It is expected that lower Corah Dental Anxiety Scale scores may be obtained after the treatment is completed, compared to the intraoral quadrant where the treatment is performed without glasses, thus reducing anxiety. Baseline
Primary Lower blood pressure and heart rate values in virtual reality application group It is expected that lower blood pressure and heart rate values will be obtained during and after treatment in the intraoral quadrant, where glasses are used, compared to the control quadrant. Baseline
Secondary Patients' feedback It is expected that positive feedback will be received by evaluating the patients' feelings. about the glasses application with the Visual Analog Scale applied after the treatment is completed. Baseline, 1st month
Secondary Dentist's feedback After the treatment, it is expected that the use of glasses in patients with anxiety will be evaluated as a viable method by taking the opinions of the physicians regarding the application. Baseline
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