Virtual Reality and Laser Biostimulation on Pain Perception and Dental Anxiety

NCT06698562 | Completed

• 1 other identifier: 2022/143
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Dental Anxiety; Pain Intensity Assessment

Keywords

pain perception; dental anxiety; children; virtual reality; dental laser

Outcome Measures

Primary Outcomes (3)

• Pain perception

  In this study, each patient received both topical anaesthesia and DSLT treatment using a split-mouth design.Pain perception was measured by Wong and Baker scale. In this scale there are 6 different facial expressions ranging from very happy to very unhappy to express the level of pain.The scale includes six faces, each illustrating a different level of pain intensity: 0 (No Pain), 1 (Very Mild Pain), 2 (Mild Pain), 3 (Moderate Pain), 4 (Severe Pain) 5 (Very Very Severe Pain). The Wong Baker facial expression pain scale was evaluated right before and immediately after the application of local anesthesia by an observer physician other than the physician administering local anesthesia. The pictures on this scale were introduced to the patient in an appropriate language. Right before and immediately after local anesthetic injection, the picture chosen by the patient was recorded on the scale.

  Right before and immediately after treatment

• Dental Anxiety

  Dental anxiety levels of the children were physiologically evaluated using the 'Venham Picture Test'. The picture chosen by the patient was recorded on the scale. The Venham Picture Test was assessed right before and immediately after local anaesthetic injection by an observer clinician other than the clinician administering the local anesthesia. The children were shown 8 pairs of pictures of boys (one "anxious" picture and one "non-anxious" picture), each drawn in a contrasting mood, and were asked to choose the picture on each card that corresponded to their feelings. A score of 1 was given if the child chose the "anxious" picture and 0 if the child chose the "non-anxious" picture. To determine the total score, the number of "anxious" pictures was summed (lowest score 0, highest score 8).

  Right before and immediately after treatment

• Pain perception

  The "Face, Legs, Activity, Cry, Consolability (FLACC)" pain assessment scale was also evaluated during local anesthesia application by an observer clinician other than the clinician to whom local anesthesia would be applied. The patient's reactions were evaluated by observation by the researcher. Pain values were determined between 0-2 for each parameter and 0-10 for the total scale score. According to the scale, the total score was evaluated as follows: 0: No pain, 1-3: Mild pain, 4-6: Moderate pain and discomfort, 7-10: Severe pain and discomfort.

  During local anesthesia application

Secondary Outcomes (1)

• Dental Anxiety

  Right before, during and immediately after the application of local anesthesia

Study Arms (4)

Group IIa Tell- Show-Do

ACTIVE COMPARATOR

Placebo topical anesthesia + LLLT + Local anesthesia

Other: Tell Show Do Group + LLLT; Other: Tell Show Do Group

Group IIb Tell- Show-Do

PLACEBO COMPARATOR

Topical anesthesia + placebo LLLT + Local anesthesia

Other: Tell Show Do Group

Group Ia Distraction (VR)

ACTIVE COMPARATOR

Placebo topical anesthesia + LLLT + Local anesthesia

Other: Distraction with Virtual reality glassess + LLLT

Grup Ib Distraction (VR)

PLACEBO COMPARATOR

Topical anesthesia + placebo LLLT + Local anesthesia

Other: Distraction with Virtual reality glassess

Interventions

Distraction with Virtual reality glassess 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

Grup Ib Distraction (VR)

Distraction with Virtual reality glassess + LLLT 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.

Group Ia Distraction (VR)

Tell Show Do Group + LLLT 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

Group IIa Tell- Show-Do

Tell Show Do Group 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.

Also known as: Group IIb

Group IIa Tell- Show-Do; Group IIb Tell- Show-Do

Eligibility Criteria

• Age: 6 Years - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• SIRIN GUNER ONUR: lead

Study Sites (1)

Altinbas University Faculty of Dentistry

Istanbul, Marmara, 34147, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Low-Level Light Therapy

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Study Officials

• SIRIN GUNER ONUR, PhD

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Model Details: The study included 40 Frankl "positive" and "definitely positive" pediatric patients between the ages of 6 and 10, applied to Altinbaş University Faculty of Dentistry Pediatric Dentistry Clinic for routine dental treatments between January 2023 and April 2023, and had no previous local anesthesia experience. This study designed as a randomized, single-center, split-mouth, double blind clinical trial.

Study Record Dates

• First Submitted: November 15, 2024
• First Posted: November 21, 2024
• Study Start: January 3, 2023
• Primary Completion: April 25, 2023
• Study Completion: May 15, 2023
• Last Updated: November 21, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)