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The Effect of Virtual Reality Glasses on Dental Anxiety Control

Primary Purpose

Periodontitis, Dental Anxiety, Dental Fear

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Scaling and root planing
Sponsored by
Kutahya Health Sciences University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Periodontitis

Eligibility Criteria

18 Years - 59 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Kutahya Health Sciences University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Virtual reality application

No application

Arm Description

Application of virtual reality glasses during scaling and root planning to a quadrant.

No application of virtual reality glasses during scaling and root planning to a quadrant.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
September 3, 2021
Last Updated
July 27, 2023
Sponsor
Kutahya Health Sciences University
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1. Study Identification

Unique Protocol Identification Number
NCT05038540
Brief Title
The Effect of Virtual Reality Glasses on Dental Anxiety Control
Official Title
Evaluation of the Effect of Virtual Reality Glasses Used During Scaling and Root Planing on Dental Anxiety Control
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
October 8, 2021 (Actual)
Primary Completion Date
November 23, 2021 (Actual)
Study Completion Date
December 23, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kutahya Health Sciences University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontitis, Dental Anxiety, Dental Fear, Gingivitis, Calculus, Dental

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Virtual reality application
Arm Type
Experimental
Arm Description
Application of virtual reality glasses during scaling and root planning to a quadrant.
Arm Title
No application
Arm Type
Active Comparator
Arm Description
No application of virtual reality glasses during scaling and root planning to a quadrant.
Intervention Type
Procedure
Intervention Name(s)
Scaling and root planing
Intervention Description
Phase 1 periodontal therapy
Primary Outcome Measure Information:
Title
Lower Corah Dental Anxiety Scale scores in virtual reality application group
Description
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.
Time Frame
Baseline
Title
Lower blood pressure and heart rate values in virtual reality application group
Description
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.
Time Frame
Baseline
Secondary Outcome Measure Information:
Title
Patients' feedback
Description
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.
Time Frame
Baseline, 1st month
Title
Dentist's feedback
Description
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.
Time Frame
Baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
59 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Kutahya Health Sciences University
City
Kütahya
Country
Turkey

12. IPD Sharing Statement

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The Effect of Virtual Reality Glasses on Dental Anxiety Control

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