Virtual Reality Distraction in Patients Undergoing Periodontal Surgery

NCT06092177 | Completed

• 1 other identifier: 03
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this randomized controlled clinical trial is to evaluate the effect of virtual reality technology on anxiety and pain levels in patients undergoing periodontal surgery. Participants will be randomly assigned into test and control groups. While the patients in the test group will undergo periodontal surgery with virtual reality distraction, the patients in the control group without distraction. After treatment, the groups will be compared regarding anxiety and pain levels.

Conditions

Virtual Reality; Oral Surgery; Dental Anxiety

Outcome Measures

Primary Outcomes (1)

• Anxiety level

  Modified dental anxiety scale where higher scores mean a worse outcome and has a minimum value of 5 and a maximum value of 25

  Preoperative, immediately postoperative

Secondary Outcomes (4)

• Pain level

  Preoperative, immediately postoperative

• Systolic blood pressure

  Preoperative, intraoperative, immediately postoperative

• Diastolic blood pressure

  Preoperative, intraoperative, immediately postoperative

• Heart rate

  Preoperative, intraoperative, immediately postoperative

Study Arms (2)

Test group

EXPERIMENTAL

The group will include patients who undergo periodontal surgery with virtual reality distraction

Procedure: Periodontal surgery with virtual reality distraction

Control group

EXPERIMENTAL

The group will include patients who undergo periodontal surgery without virtual reality distraction

Procedure: Periodontal surgery without virtual reality distraction

Interventions

Periodontal surgery with virtual reality distraction PROCEDURE

Periodontal surgery to improve gingival contour and eliminate inflamed periodontal pockets

Test group

Periodontal surgery without virtual reality distraction PROCEDURE

Periodontal surgery to improve gingival contour and eliminate inflamed periodontal pockets

Control group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Individuals over the age of 18
• Systemically healthy patients
• Need for periodontal surgical treatment in the mandibular anterior region
• Scoring 15 or above on the modified 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, especially around the eyes
• A lesion in the eye that will prevent the use of virtual reality glasses
• Systemic disease and medication use that contraindicate periodontal surgery

Sponsors & Collaborators

• Kutahya Health Sciences University: lead

Study Sites (1)

Kutahya Health Sciences University

Kütahya, 43100, Turkey (Türkiye)

Location

Related Publications (1)

• Gurbuz E, Gurbuz AA. Investigation of the effect of virtual reality distraction in patients undergoing mandibular periodontal surgery: A randomized controlled study. J Esthet Restor Dent. 2024 May;36(5):813-822. doi: 10.1111/jerd.13203. Epub 2024 Feb 5.

  PMID: 38314536 DERIVED

Study Officials

• Ezgi Gurbuz

  Kutahya Health Sciences University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: October 15, 2023
• First Posted: October 23, 2023
• Study Start: May 2, 2022
• Primary Completion: April 3, 2023
• Study Completion: May 2, 2023
• Last Updated: October 23, 2023

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)