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A split-mouth, controlled trial aimed to clinically compare and evaluate the effectiveness of virtual reality versus topical anesthesia gel prior to administration of dental anesthesia injection in reducing the perceived pain and anxiety level in adult patients and to find out their preferred procedure.
Heart rate before and after the end of the procedure will be identified, pain intensity of the injection will be identified using a scale, and finally patients' preference will be identified using a questionnaire.
Steps of the Experiment
Step I: before the administration of the local anesthesia injection, heart rate will be measured for the patients using an FDA Approved pulse oximeter (Santa Medical SM-165 Finger Pulse Oximeter). Findings will be recorded.
Step II: at the first appointment, patients will be randomly allocated to receive the injection of the local anesthesia either with topical anesthetic gel or with virtual reality in one side of the jaw.
Step III: immediately after dental anesthesia injection procedure, the patient will be asked to rate the level of perceived pain, using Wong-Baker faces pain rating scale (WBFPS).
Step IV: after the administration of the local anesthesia injection, heart rate will be measured for the patients an FDA Approved pulse oximeter (Santa Medical SM-165 Finger Pulse Oximeter). Findings will be recorded.
Step V: in the next appointment, the other technique (virtual reality or topical anesthetic gel) will be used on the contralateral side for the same patients.
So each patient will receive local anesthesia injection twice, one with topical anesthetic gel and one else with VR in the contralateral side.
Step VI: after completion of both procedures, each patient will be asked to state his/her preference for the delivery system of future injections to be recorded.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Virtual reality | Active Comparator | Participants will wear a virtual reality headset during the dental injection in which a video is playing. |
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| Topical gel | Active Comparator | Participants will receive application of topical anesthetic gel on the site of dental injection. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dental injection and topical gel application | Drug | Topical anesthesia gel will be applied followed by dental injection with 1.8 ml Xylocaine 20mg/ml (DENSPLY Pharmaceutical); adrenaline: 1 : 100.000, delivered in cartridges using a 27 -gauge short needle (0.4 x 25 mm,C-K jet) and sterile non-aspirating syringe. |
| Measure | Description | Time Frame |
|---|---|---|
| Heart rate | heart rate will be measured for the participants using an FDA Approved pulse oximeter (Santa Medical SM-165 Finger Pulse Oximeter) | immediately after the intervention/procedure (injection) |
| Wong-Baker faces pain rating scale (WBFPS) | A tool to measure the intensity of pain comprising a scale from 0 to 10. The patient will select a number based on the intensity of the pain, "0" means no pain, "10" means extremely severe pain. | 3 minutes after the intervention/procedure (injection) |
| Participant's future preference | Each participant will be asked by a questionnaire to state his/her preference for the delivery system of future injections | 5 minutes after the intervention/procedure (injection) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ammar AbuMostafa, BDS, MSC | Riyadh Elm University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Riyadh Elm University | Riyadh | Saudi Arabia |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Apr 28, 2021 | May 28, 2021 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D003752 | Dental Health Services |
| ID | Term |
|---|---|
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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| Dental injection and virtual reality device | Device | Dental injection will be made while the participants are wearing virtual reality device. |
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