PeriodontitisNCT05038540
The Effect of Virtual Reality Glasses on Dental Anxiety Control
A study testing Scaling and root planing in people with Periodontitis and Dental Anxiety, run by Kutahya Health Sciences University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 59 years
- Conditions the study is for
- Periodontitis, Dental Anxiety, Dental Fear
- What is being tested?
- Scaling and root planing
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 8 Oct 2021to 23 Dec 2021
- 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 59 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Effect of Virtual Reality Glasses Used During Scaling and Root Planing on Dental Anxiety Control
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.
- Conditions
- Periodontitis, Dental Anxiety, Dental Fear, Gingivitis, Calculus, Dental
- Being tested
- Scaling and root planing
- Medical subject headings
- Periodontitis, Gingivitis, Dental Calculus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Scaling and root planingProcedure or surgery
Phase 1 periodontal therapy
| Study group | Role | What they receive |
|---|---|---|
| Virtual reality application | Experimental | Application of virtual reality glasses during scaling and root planning to a quadrant. Receives: Procedure: Scaling and root planing |
| No application | Active comparator | No application of virtual reality glasses during scaling and root planning to a quadrant. Receives: Procedure: Scaling and root planing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
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.
Measured: Baseline
Secondary outcomes (2)
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.
Measured: Baseline, 1st month
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2021
- Study start8 Oct 2021
- Primary completion23 Nov 2021
- Study completion23 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PeriodontitisStudies of the same condition, open and under way.
- More trials run by Kutahya Health Sciences UniversityThe sponsor's other registered studies.
- 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
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kutahya Health Sciences University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ezgi Gürbüz, Kutahya Health Sciences University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05038540
- Sponsor's protocol ID
- 00
- Status last verified
- Jul 2023
- First submitted
- 3 Sep 2021
- Last updated
- 1 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Virtual Reality Glasses Used During Scaling and Root Planing on Dental Anxiety Control
- ClinicalTrials.gov ID
- NCT05038540
- Acronym / sponsor ID
- 00
- Conditions
- Periodontitis, Dental Anxiety, Dental Fear, Gingivitis, Calculus, Dental
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Kutahya Health Sciences UniversityUniversity, hospital or other
- Study start
- 8 Oct 2021 (actual)
- Primary completion
- 23 Nov 2021 (actual)
- Study completion
- 23 Dec 2021 (actual)
- First posted
- 9 Sep 2021 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtual reality application | Experimental | Procedure: Scaling and root planingApplication of virtual reality glasses during scaling and root planning to a quadrant. |
| No application | Active comparator | Procedure: Scaling and root planingNo application of virtual reality glasses during scaling and root planning to a quadrant. |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
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 |
|---|---|---|
| Scaling and root planingPhase 1 periodontal therapy | Procedure or surgery | No application, Virtual reality application |
Primary outcome
Lower Corah Dental Anxiety Scale scores in virtual reality application group
Time frame: Baseline
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
Time frame: Baseline
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.
2 secondary outcomes
Patients' feedback
Time frame: Baseline, 1st month
Dentist's feedback
Time frame: Baseline
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 1 Aug 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Scaling and root planing in people with Periodontitis and Dental Anxiety, run by Kutahya Health Sciences 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 5 inclusion and 6 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 1 Aug 2023. 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?
Lower Corah Dental Anxiety Scale scores in virtual reality application group (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Aug 2023.