Anesthesia EffectivenessNCT07571278
Pain Perception During Inferior Alveolar Nerve Block Administration in Children Using Vibraject and Dental Vibe Versus Conventional Syringe
A study testing Vibraject, Dental vibe and Conventional syringe in people with Anesthesia Effectiveness, run by Cairo University at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 6 to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Anesthesia Effectiveness
- What is being tested?
- Vibraject, Dental vibe and Conventional syringe
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- May 2026to Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 8 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children aged 6-8 years.
- Cooperative children (Rating 3 or 4 based on the Frankl behaviour scale).
- Medically fit children (ASA I).
- Children mentally capable of communication.
- First dental visit (no previous history of injection of LA).
- Patient requiring extraction/pulp therapy/cavity preparation in mandibular primary molars
Who cannot join
- Uncooperative patient (other than 3 or 4 based on the Frankl behaviour scale).
- Medically unfit children (other than ASA 1).
- Parental refusal of participation.
- Children under medications (antibiotics and analgesics) for the previous 48 hours that could alter the pain perception.
- Children who are allergic to local anaesthesia.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Faculty of Dentistry,Cairo University
Cairo, 11411
Yasmeen MHM Amer, Bachelors', 00201124054504, yasmeen.mohamed@cu.edu.eg
About this study
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
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.
Read the detailed description
This randomized controlled clinical trial aims to compare pain perception of Vibraject and dental vibe during inferior alveolar nerve block in lower primary molars indiacted for extraction,pulp therapy and cavity preparation in children aged 6-8 years.
Pain during local anesthesia remains a major concern in pediatric dentistry, as it contributes significantly to fear, anxiety, and uncooperative behavior in children. Vibration devices, based on the gate control theory of pain, have been introduced as a non-pharmacological method to reduce injection discomfort.
Ninety children will be randomly allocated into 3 parallel groups(1:1:1): Inferior alveolar nerve block Injection using Vibraject system,Inferior alveolar nerve block Injection using Dentalvibe system, Inferior alveolar nerve block Injection using the Conventional Syringe.
All participants will undergo standardized procedures, including topical anesthesia application followed by local anesthetic injection using articaine. Pain perception during injection will be assessed using both subjective and objective measures.
The primary outcome is subjective pain perception during injection measured using Wong-Baker Scale,While secondary outcome is objective pain perception during injection measured using FLACC Scale,Finally The Physiological parameters(heart rate, oxygen saturation )will be measured at two time points: baseline and during injection using pulse oximeter device on child's index finger.
The Findings of this study aims to provide evidence-based guidance on the optimal non pharmacological technique to enhance pain-controlled dental procedures allowing better quality of dental treatment and Improve the patient's cooperation and acceptance for future dental visits.
- Conditions
- Anesthesia Effectiveness
- Being tested
- Vibraject, Dental vibe, Conventional syringe
- Keywords
- Vibraject, Dental vibe, Pain perception, Inferior alveolar nerve block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VibrajectDevice
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 vibeDevice
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 syringeDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Inferior alveolar nerve block Injection using Vibraject system(MiltexInc LLC.,York,PA,USA). | Experimental | VibraJect is a compact, battery-operated unit that attaches directly to a standard dental syringe, generating high-frequency vibrations along the needle to attenuate pain during anesthetic delivery. If these devices prove efficacy, they may offer a rapid, non-pharmacologic method to enhance the comfort of children undergoing local anesthesia. Receives: Device: Vibraject |
| Inferior alveolar nerve block Injection using Dentalvibe system (BING Innovations LLC,Crystal La). | Experimental | The DentalVibe device is a cordless, rechargeable instrument that produces controlled, pulsed micro-vibrations at the injection site. It features a U-shaped vibrating tip connected to a microprocessor-driven VibraPulse motor, allowing gentle stimulation of sensory receptors, illumination of the injection area, and retraction of the cheek or lip. Receives: Device: Dental vibe |
| Inferior alveolar nerve block Injection using the Conventional Syringe. | Active comparator | A conventional metal aspirating syringe Receives: Device: Conventional syringe |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective pain during injection
Wong-Baker Scale: represents a series of faces from a 0-value happy face (which represents lack of pain) to a 10-value crying face (which suggests the worst possible pain). On this basis, the patient chooses the face that best describes his/her level of pain.
Measured: during injection
Secondary outcomes (1)
Objective pain during injection
Faces, Legs, Arms, Crying, Consolability (FLACC) scale: a measurement tool used to assess the intensity of pain for young children and infants or children that are unable to communicate their pain with exposed body and limbs. The scale is scored in a range of 0-10 with 0 representing no pain. The observation lasts for 2-5 minutes. Each parameter is evaluated on a scale from 0 to 2; the total score is interpreted as follows: 0=relaxed and comfortable, 1-3=mild discomfort, 4- 6=moderate pain, 7-10=severe discomfort/pain.
- Physiological parameters (heart rate, oxygen saturation ) at two time points: baseline, during injection using pulse oximeter Pulse oximetry: non-invasive monitoring technique that measures the heart rate and the oxygen saturation in the blood by shining light at specific wavelengths through tissue, most commonly the fingernail bed, pulse oximetry is the standard of care to use pulse oximetry to monitor oxygen saturation for patients receiving anesthesia.
Measured: Baseline and during injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2026
- Study startMay 2026 (estimated)
- Primary completionAug 2026 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anesthesia EffectivenessStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasmeen Mohamed Hussein Mohamed Amer, Cairo University
- Investigators
- Mahmoud H Eid, Professor, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07571278
- Sponsor's protocol ID
- anesthesia technique-2026
- Status last verified
- Apr 2026
- First submitted
- 30 Apr 2026
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07571278
- Acronym / sponsor ID
- anesthesia technique-2026
- Conditions
- Anesthesia Effectiveness
- Keywords
- Vibraject, Dental vibe, Pain perception, Inferior alveolar nerve block
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- May 2026 (estimated)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 6 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This randomized controlled clinical trial aims to compare pain perception of Vibraject and dental vibe during inferior alveolar nerve block in lower primary molars indiacted for extraction,pulp therapy and cavity preparation in children aged 6-8 years.
Pain during local anesthesia remains a major concern in pediatric dentistry, as it contributes significantly to fear, anxiety, and uncooperative behavior in children. Vibration devices, based on the gate control theory of pain, have been introduced as a non-pharmacological method to reduce injection discomfort.
Ninety children will be randomly allocated into 3 parallel groups(1:1:1): Inferior alveolar nerve block Injection using Vibraject system,Inferior alveolar nerve block Injection using Dentalvibe system, Inferior alveolar nerve block Injection using the Conventional Syringe.
All participants will undergo standardized procedures, including topical anesthesia application followed by local anesthetic injection using articaine. Pain perception during injection will be assessed using both subjective and objective measures.
The primary outcome is subjective pain perception during injection measured using Wong-Baker Scale,While secondary outcome is objective pain perception during injection measured using FLACC Scale,Finally The Physiological parameters(heart rate, oxygen saturation )will be measured at two time points: baseline and during injection using pulse oximeter device on child's index finger.
The Findings of this study aims to provide evidence-based guidance on the optimal non pharmacological technique to enhance pain-controlled dental procedures allowing better quality of dental treatment and Improve the patient's cooperation and acceptance for future dental visits.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Inferior alveolar nerve block Injection using Vibraject system(MiltexInc LLC.,York,PA,USA). | Experimental | Device: VibrajectVibraJect is a compact, battery-operated unit that attaches directly to a standard dental syringe, generating high-frequency vibrations along the needle to attenuate pain during anesthetic delivery. If these devices prove efficacy, they may offer a rapid, non-pharmacologic method to enhance the comfort of children undergoing local anesthesia. |
| Inferior alveolar nerve block Injection using Dentalvibe system (BING Innovations LLC,Crystal La). | Experimental | Device: Dental vibeThe DentalVibe device is a cordless, rechargeable instrument that produces controlled, pulsed micro-vibrations at the injection site. It features a U-shaped vibrating tip connected to a microprocessor-driven VibraPulse motor, allowing gentle stimulation of sensory receptors, illumination of the injection area, and retraction of the cheek or lip. |
| Inferior alveolar nerve block Injection using the Conventional Syringe. | Active comparator | Device: Conventional syringeA conventional metal aspirating syringe |
Who may qualify
- Ages
- 6 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Children aged 6-8 years.
- Cooperative children (Rating 3 or 4 based on the Frankl behaviour scale).
- Medically fit children (ASA I).
- Children mentally capable of communication.
- First dental visit (no previous history of injection of LA).
Key exclusion criteria (5 listed)
- Uncooperative patient (other than 3 or 4 based on the Frankl behaviour scale).
- Medically unfit children (other than ASA 1).
- Parental refusal of participation.
- Children under medications (antibiotics and analgesics) for the previous 48 hours that could alter the pain perception.
- Children who are allergic to local anaesthesia.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VibrajectFamiliarize 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. | Device | Inferior alveolar nerve block Injection using Vibraject system(MiltexInc LLC.,York,PA,USA). |
| Dental vibeFamiliarize 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. | Device | Inferior alveolar nerve block Injection using Dentalvibe system (BING Innovations LLC,Crystal La). |
| Conventional syringeDry 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. | Device | Inferior alveolar nerve block Injection using the Conventional Syringe. |
Primary outcome
Subjective pain during injection
Time frame: during injection
Wong-Baker Scale: represents a series of faces from a 0-value happy face (which represents lack of pain) to a 10-value crying face (which suggests the worst possible pain). On this basis, the patient chooses the face that best describes his/her level of pain.
1 secondary outcome
Objective pain during injection
Time frame: Baseline and during injection
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mahmoud H Eid, Professor study director
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vibraject, Dental vibe and Conventional syringe in people with Anesthesia Effectiveness, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yasmeen MHM Amer, Bachelors (+201124054504, yasmeen.mohamed@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subjective pain during injection (time frame: during injection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2026.