Virtual Reality and Laser Biostimulation on Pain Perception and Dental Anxiety

NCT ID: NCT06698562

Last Updated: 2024-11-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-03
• Study Completion Date: 2023-05-15

Brief Summary

Dental anxiety in children can prevent planned treatment from being carried out, negatively affect the child's relationship with the dentist and make the treatment process difficult. The most common sources of directly anticipated anxiety are known to be associated with pain. Painful experiences are anxiety-provoking for people of all ages, especially children.This study aims to evaluate the effect of virtual reality glassess (VR) and low-level laser therapy (LLLT) on dental anxiety and pain perception during local anaesthesia administration in paediatric patients.

Detailed Description

This study aims to investigate the combined effects of virtual reality glassess (VR) and low-level laser therapy (LLLT) on dental anxiety and pain perception in paediatric patients undergoing local anaesthesia for dental procedures. Dental anxiety is a common issue in children, often leading to increased pain perception and poor cooperation during treatment. Virtual reality has been proposed as a distraction technique, while LLLT is believed to reduce pain and inflammation. By exploring the effectiveness of these two interventions, the study seeks to determine whether VR and LLLT can serve as effective adjuncts to improve patient comfort, reduce anxiety, and enhance overall treatment experience during the administration of local anaesthesia

Conditions

Dental Anxiety; Pain Intensity Assessment

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Group IIa Tell- Show-Do

Placebo topical anesthesia + LLLT + Local anesthesia

Group Type: ACTIVE_COMPARATOR

Tell Show Do Group + LLLT

Intervention Type: OTHER

The injection site was dried with a cotton pellet and placebo topical anaesthesia was applied with a pre-sterilised wooden ear stick in a circular motion followed by laser biostimulation. The Wiser diode laser (Doctor Smile, Vicenza, Italy), a diode laser device with a wavelength of 980 nm and equipped with a 600 μm diameter fibre, was used to deliver low-level laser therapy to the area of interest. The tip of the laser carrier system was placed at a distance of 1 cm from the target tissue without contact and applied with continuous circular movements as recommended by the manufacturer. A silicone piece was placed on the end of the carrier system to ensure that the distance to the tissue remained constant in each application. The focal spot area was determined as 0.087 cm2. The power of the laser used in our study was determined as 0.3 W and the application time was selected as 60 seconds. During the whole procedure, the patient wore virtual glasses and the physician wore protective go

Tell Show Do Group

Intervention Type: OTHER

In this session, the injection area was dried with a cotton pellet before injection. A topical anaesthetic gel containing 20% benzocaine (Vision pat gel) was applied to the mucosal tissues to be injected using a pre-sterilised ear stick. After the application of the topical anaesthetic agent, the laser device was positioned in the same way, but without applying energy, and the sound of the laser device was pre-recorded and the study was blinded. In this way, a placebo effect was created and the patient was prevented from distinguishing between the laser and non-laser session. After this procedure, local anaesthesia was applied.

Group IIb Tell- Show-Do

Topical anesthesia + placebo LLLT + Local anesthesia

Group Type: PLACEBO_COMPARATOR

Tell Show Do Group

Intervention Type: OTHER

In this session, the injection area was dried with a cotton pellet before injection. A topical anaesthetic gel containing 20% benzocaine (Vision pat gel) was applied to the mucosal tissues to be injected using a pre-sterilised ear stick. After the application of the topical anaesthetic agent, the laser device was positioned in the same way, but without applying energy, and the sound of the laser device was pre-recorded and the study was blinded. In this way, a placebo effect was created and the patient was prevented from distinguishing between the laser and non-laser session. After this procedure, local anaesthesia was applied.

Group Ia Distraction (VR)

Placebo topical anesthesia + LLLT + Local anesthesia

Group Type: ACTIVE_COMPARATOR

Distraction with Virtual reality glassess + LLLT

Intervention Type: OTHER

The injection area was dried with a cotton pellet before injection. A topical anaesthetic gel containing 20% benzocaine (Vision pat gel) was applied to the mucosal tissues to be injected using a pre-sterilised ear stick. After the application of the topical anaesthetic agent, the laser device was positioned in the same way, but without applying energy, and the sound of the laser device was pre-recorded and the study was blinded. In this way, a placebo effect was created and the patient was prevented from distinguishing between the laser and non-laser session. After this procedure, local anaesthesia was applied.

Grup Ib Distraction (VR)

Topical anesthesia + placebo LLLT + Local anesthesia

Group Type: PLACEBO_COMPARATOR

Distraction with Virtual reality glassess

Intervention Type: OTHER

the injection site was dried with a cotton pellet and placebo topical anaesthesia was applied with a pre-sterilised wooden ear stick in a circular motion followed by laser biostimulation. The Wiser diode laser (Doctor Smile, Vicenza, Italy), a diode laser device with a wavelength of 980 nm and equipped with a 600 μm diameter fibre, was used to deliver low-level laser therapy to the area of interest. The tip of the laser carrier system was placed at a distance of 1 cm from the target tissue without contact and applied with continuous circular movements as recommended by the manufacturer. A silicone piece was placed on the end of the carrier system to ensure that the distance to the tissue remained constant in each application. The focal spot area was determined as 0.087 cm2. The power of the laser used in our study was determined as 0.3 W and the application time was selected as 60 seconds. The patient and the physician wore protective goggles during the whole procedure to prevent possi

Interventions

Distraction with Virtual reality glassess

the injection site was dried with a cotton pellet and placebo topical anaesthesia was applied with a pre-sterilised wooden ear stick in a circular motion followed by laser biostimulation. The Wiser diode laser (Doctor Smile, Vicenza, Italy), a diode laser device with a wavelength of 980 nm and equipped with a 600 μm diameter fibre, was used to deliver low-level laser therapy to the area of interest. The tip of the laser carrier system was placed at a distance of 1 cm from the target tissue without contact and applied with continuous circular movements as recommended by the manufacturer. A silicone piece was placed on the end of the carrier system to ensure that the distance to the tissue remained constant in each application. The focal spot area was determined as 0.087 cm2. The power of the laser used in our study was determined as 0.3 W and the application time was selected as 60 seconds. The patient and the physician wore protective goggles during the whole procedure to prevent possi

Intervention Type: OTHER

Distraction with Virtual reality glassess + LLLT

The injection area was dried with a cotton pellet before injection. A topical anaesthetic gel containing 20% benzocaine (Vision pat gel) was applied to the mucosal tissues to be injected using a pre-sterilised ear stick. After the application of the topical anaesthetic agent, the laser device was positioned in the same way, but without applying energy, and the sound of the laser device was pre-recorded and the study was blinded. In this way, a placebo effect was created and the patient was prevented from distinguishing between the laser and non-laser session. After this procedure, local anaesthesia was applied.

Intervention Type: OTHER

Tell Show Do Group + LLLT

The injection site was dried with a cotton pellet and placebo topical anaesthesia was applied with a pre-sterilised wooden ear stick in a circular motion followed by laser biostimulation. The Wiser diode laser (Doctor Smile, Vicenza, Italy), a diode laser device with a wavelength of 980 nm and equipped with a 600 μm diameter fibre, was used to deliver low-level laser therapy to the area of interest. The tip of the laser carrier system was placed at a distance of 1 cm from the target tissue without contact and applied with continuous circular movements as recommended by the manufacturer. A silicone piece was placed on the end of the carrier system to ensure that the distance to the tissue remained constant in each application. The focal spot area was determined as 0.087 cm2. The power of the laser used in our study was determined as 0.3 W and the application time was selected as 60 seconds. During the whole procedure, the patient wore virtual glasses and the physician wore protective go

Intervention Type: OTHER

Tell Show Do Group

In this session, the injection area was dried with a cotton pellet before injection. A topical anaesthetic gel containing 20% benzocaine (Vision pat gel) was applied to the mucosal tissues to be injected using a pre-sterilised ear stick. After the application of the topical anaesthetic agent, the laser device was positioned in the same way, but without applying energy, and the sound of the laser device was pre-recorded and the study was blinded. In this way, a placebo effect was created and the patient was prevented from distinguishing between the laser and non-laser session. After this procedure, local anaesthesia was applied.

Intervention Type: OTHER

Other Intervention Names

Group IIb

Eligibility Criteria

Inclusion Criteria

• No history of systemic disease or infectious disease
• Compliant with the dental treatments to be performed in the Children's Dental Hospital and able to answer the questions asked
• Exhibiting 'positive' and 'absolutely positive' behaviours during the examination, compliant according to the Frankl scale,
• Children with no previous experience of dental treatment with local anaesthesia

Exclusion Criteria

• Children with any systemic condition
• Mentally and physically disabled, unable to co-operate,
• Children allergic to local anaesthesia,
• Previous dental treatment experience with local anaesthesia
• Exhibiting "negative" and "strongly negative" behaviour according to the Frankl scale
• Children with eye diseases such as myopia and astigmatism

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 10 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

SIRIN GUNER ONUR

OTHER

Sponsor Role: lead

Responsible Party

SIRIN GUNER ONUR

Associate Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

SIRIN GUNER ONUR, PhD

Role: STUDY_DIRECTOR

Locations

Altinbas University Faculty of Dentistry

Istanbul, Marmara, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

2022/143

Identifier Type: -

Identifier Source: org_study_id