NCT05038540

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 3, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 9, 2021

Completed
29 days until next milestone

Study Start

First participant enrolled

October 8, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 23, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 23, 2021

Completed
Last Updated

August 1, 2023

Status Verified

July 1, 2023

Enrollment Period

2 months

First QC Date

September 3, 2021

Last Update Submit

July 27, 2023

Conditions

PeriodontitisDental AnxietyDental FearGingivitisCalculus, Dental

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (2)

  • Patients' feedback

    Baseline, 1st month

  • Dentist's feedback

    Baseline

Study Arms (2)

Virtual reality application

EXPERIMENTAL

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

Procedure: Scaling and root planing

No application

ACTIVE COMPARATOR

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

Procedure: Scaling and root planing

Interventions

Scaling and root planingPROCEDURE

Phase 1 periodontal therapy

No applicationVirtual reality application

Eligibility Criteria

Age18 Years - 59 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kutahya Health Sciences University

Kütahya, Turkey (Türkiye)

Location

MeSH Terms

Conditions

PeriodontitisGingivitisDental Calculus

Interventions

Tooth ExfoliationRoot Planing

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic DiseasesInfectionsGingival DiseasesDental DepositsTooth DiseasesCalculiPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dental Physiological PhenomenaDigestive System and Oral Physiological PhenomenaDental ScalingDental ProphylaxisPeriodonticsDentistrySubgingival CurettagePreventive Dentistry

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

September 3, 2021

First Posted

September 9, 2021

Study Start

October 8, 2021

Primary Completion

November 23, 2021

Study Completion

December 23, 2021

Last Updated

August 1, 2023

Record last verified: 2023-07

Locations

TU(1)