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Pain Perception During Inferior Alveolar Nerve Block Administration in Children Using Vibraject and Dental Vibe Versus Conventional Syringe
Sponsor: Cairo University
Summary
This RCT study aims to establish evidence based decision comparing between Vibraject (MiltexInc LLC.,York,PA,USA).and Dental vibe(BING Innovations LLC,Crystal Lake,IL,USA versus Conventional Syringe on pain perception during inferior alveolar nerve block anesthesia in lower primary molars indicated for extraction,pulp therapy and cavity preparation in Children.
Official title: Pain Perception During Inferior Alveolar Nerve Block Administration in Children Using Vibraject and Dental Vibe Versus Conventional Syringe: A Randomized Controlled Clinical Trial
Key Details
Gender
All
Age Range
6 Years - 8 Years
Study Type
INTERVENTIONAL
Enrollment
90
Start Date
2026-05
Completion Date
2027-08
Last Updated
2026-05-08
Healthy Volunteers
Yes
Conditions
Interventions
Vibraject
Familiarize the child with the Vibraject device, allowing them to feel the vibrations on their hand to reduce anxiety. Dry the injection site with sterile gauze. Apply 20% benzocaine gel for 1 minute using a cotton swab. Use a conventional syringe with the Vibraject attachment, 4% articaine (1:100,000 epi), and a 27-gauge long needle. Deliver an inferior alveolar and lingual nerve block. Slowly deposit 1.5 mL of anesthetic over at least 60 seconds to minimize discomfort. Use the FLACC scale (objective) during injection and the Wong-Baker FACES scale (subjective) immediately after. Monitor heart rate and oxygen saturation via pulse oximetry at baseline and during injection. Confirm anesthesia after 3-5 minutes via numbness (subjective) and lack of pain during instrumentation (objective). Perform (extraction or pulp therapy or cavity preparation) per AAPD guidelines. Provide post-operative instructions to the parent and evaluate the need for a space maintainer.
Dental vibe
Familiarize the child with the DentalVibe device, letting them feel the vibrations on the back of their hand. Dry the mucosa with gauze and apply 20% benzocaine gel for 1 minute. Apply the DentalVibe to the buccal mucosa for pre-injection vibration. Using a conventional syringe (4% articaine, 1:100,000 epi, 27G needle), perform the mandibular block simultaneously while the DentalVibe is active. Slowly deposit 1.5 mL (1.0 mL alveolar / 0.5 mL lingual) over at least 60 seconds. Evaluate pain using the FLACC scale (during) and the Wong-Baker FACES scale (after). Record heart rate and oxygen saturation at baseline and during the injection. After 3-5 minutes, confirm anesthesia via subjective numbness and objective lack of pain during instrumentation. Perform treatment (extraction/pulp therapy/cavity prep) per AAPD guidelines. Provide post-operative care instructions and assess the need for space maintainers.
Conventional syringe
Dry the injection site with sterile gauze. Apply 20% benzocaine gel for 1 minute using a cotton swab to ensure surface numbing. Use a conventional metal aspirating syringe with 4% articaine (1:100,000 epi) and a 27-gauge long needle. Deliver a mandibular inferior alveolar nerve block. Slowly deposit 1.5 mL total (1.0 mL for the alveolar nerve and 0.5 mL for the lingual nerve) over a minimum of 60 seconds. Evaluate pain using the FLACC scale (during) and the Wong-Baker FACES scale (after). Record heart rate and oxygen saturation at baseline and during the injection. After 3-5 minutes, confirm anesthesia via subjective numbness and objective lack of pain during instrumentation. Perform (extraction, pulp therapy, or cavity preparation) according to AAPD guidelines. Provide post-operative care instructions and evaluate the patient for potential space maintainer requirements.
Locations (1)
Faculty of Dentistry,Cairo University
Cairo, Egypt