Pain ManagementNCT07324915
EFFECT OF BUZZY BEE TO REDUCE PAIN PERECEPTION DURING INFERIOR ALVEOLAR NERVE BLOCK IN CHILDREN - A CROSS OVER STUDY
A study testing BUZZY BEE [ Vibrating device] and Conventional technique in people with Pain Management, run by University of Jazan at 1 site in Saudi Arabia.
Trial summary
Pain management during invasive dental procedures is crucial to avoid noncompliance and treatment avoidance. Thus, measures to reduce injection discomfort are needed to prevent patients from avoiding dental treatment. Tooth extractions, and invasive dental procedures cause pain. Read more about this study
- Who is it for?
- Ages 7 to 9 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain Management
- What is being tested?
- BUZZY BEE [ Vibrating device] and Conventional technique
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 22 Dec 2025to 28 Mar 2026
- 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 7 to 9 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy children with no systemic illness, allergies
- Co-operative child
- Patient requiring block for dental treatment
- children with proper parental consent Exclusion criteria
- 1. Children with systemic illness and allergy 2. Un co-operative child
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effect of Buzzy Bee to Reduce Pain Perception During Inferior Alveolar Nerve Block in Children - A Cross Over Study
Pain management during invasive dental procedures is crucial to avoid noncompliance and treatment avoidance. Thus, measures to reduce injection discomfort are needed to prevent patients from avoiding dental treatment. Tooth extractions, and invasive dental procedures cause pain. Local anesthetics are one of the most effective and safest pain relievers. Even though many children have needle fear, anesthetic may still be uncomfortable. Fear of pain, especially in young children, is real since it affects health outcomes. Anxiety and fear may delay dental treatment and harm the patient's oral health. Distraction, topical anesthetic gel, modifying infiltration rate, intra-oral vibrating devices, computerized delivery systems, pre-cooling injection site, and other pharmacological, physical, and psychological interventions have all been proposed as potential pain relievers. An example of this kind of system One approach that combines an extraoral cold with a vibrating device is Buzzy Bee.
Read the detailed description
Before start of the study a written informed consent will be obtained from each parent of the children included in the study stating they accepted the treatment. The study will be performed among children aged 7 to 9 years and who required inferior alveolar block for their treatment. Children who needed anaesthesia for dental treatment will be randomly divided into two groups Group A and Group B using a lottery randomization technique. control group: the children in this group will be delivered Inferior alveolar nerve block in a conventional way [1 min of topical anaesthesia and local infiltration] Experimental group: A Buzzy external cold and vibrating device will be used on the site of application [right/left face] 2 minutes before anaesthesia and this application will be maintained throughout the injection.
At the first visit, the children in Group A will receive the control intervention and those in group B will receive the experimental intervention. A wash out period of 7 days was observed, after which the second visit will be scheduled. At the second visit, the children in Group A will receive the experimental intervention and Group B will receive the control intervention. Demographic details, informed consent from the parents, and assent from the children will be obtained before the commencement of the study. Outcomes will be recorded as primary and secondary outcomes. primary outcomes includes FLACC, WBS and parental scale where as secondary outcomes will be pulse rate and Frankel behaviour rating scale.
Pulse rate will be recorded before anaesthesia, during anaesthesia and 1 min after delivery of anaesthesia, Frankel behaviour rating scale will be measured before, during and after anaesthesia procedures. FLACC and WBS scales will be used to objectively and subjectively record the pain perception. parental scale will be used to determine parental view regarding pain scale during anaesthesia procedure.
- Conditions
- Pain Management
- Being tested
- BUZZY BEE [ Vibrating device], Conventional technique
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BUZZY BEE [ Vibrating device]Device
Also called EXPERIMENTAL
already described
Conventional techniqueDevice
described
| Study group | Role | What they receive |
|---|---|---|
| BUZZY BEE | Experimental | Vibrating device Receives: Device: BUZZY BEE [ Vibrating device] |
| Conventional technique | Active comparator | conventional way Receives: Device: Conventional technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
SEM
Sound, Eye, Motor
Measured: During the delivery of anesthesia
WBS
WONG BAKER SCALE
Measured: During the delivery of anesthesia
parental scale
PARENTAL SCALE
Measured: after administration of anesthesia
Secondary outcomes (2)
PULSE RATE
Pulse rate examined with a pulse oximeter
Measured: Measured three times. 15 minutes before the delivery of anesthesia, b. At the time of delivery of anesthesia and c. 1 minute after the delivery of anesthesia
BEHAVIOURAL RATING SCALE
Behaviour was measured using behaviour rating scale either definitely negative, negative, positive or positive behaviour
Measured: Measured three times. 15 minutes before the delivery of anesthesia, b. At the time of delivery of anesthesia and c. 1 minute after the delivery of anesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2026
- Study start22 Dec 2025
- Primary completion28 Jan 2026
- Study completion28 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain ManagementStudies of the same condition, open and under way.
- 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
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Jazan
- Sponsor type
- Other government
- Responsible party
- Principal investigator, satish vishwanathaiah, University of Jazan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07324915
- Sponsor's protocol ID
- COLLEGE OF DENTISTRY jazan
- Status last verified
- Mar 2026
- First submitted
- 23 Dec 2025
- Last updated
- 9 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 9 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Buzzy Bee to Reduce Pain Perception During Inferior Alveolar Nerve Block in Children - A Cross Over Study
- ClinicalTrials.gov ID
- NCT07324915
- Acronym / sponsor ID
- COLLEGE OF DENTISTRY jazan
- Conditions
- Pain Management
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of JazanOther government
- Study start
- 22 Dec 2025 (actual)
- Primary completion
- 28 Jan 2026 (actual)
- Study completion
- 28 Mar 2026 (estimated)
- First posted
- 8 Jan 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.
Pain management during invasive dental procedures is crucial to avoid noncompliance and treatment avoidance. Thus, measures to reduce injection discomfort are needed to prevent patients from avoiding dental treatment. Tooth extractions, and invasive dental procedures cause pain. Local anesthetics are one of the most effective and safest pain relievers. Even though many children have needle fear, anesthetic may still be uncomfortable. Fear of pain, especially in young children, is real since it affects health outcomes. Anxiety and fear may delay dental treatment and harm the patient's oral health. Distraction, topical anesthetic gel, modifying infiltration rate, intra-oral vibrating devices, computerized delivery systems, pre-cooling injection site, and other pharmacological, physical, and psychological interventions have all been proposed as potential pain relievers. An example of this kind of system One approach that combines an extraoral cold with a vibrating device is Buzzy Bee.
Detailed description
Before start of the study a written informed consent will be obtained from each parent of the children included in the study stating they accepted the treatment. The study will be performed among children aged 7 to 9 years and who required inferior alveolar block for their treatment. Children who needed anaesthesia for dental treatment will be randomly divided into two groups Group A and Group B using a lottery randomization technique. control group: the children in this group will be delivered Inferior alveolar nerve block in a conventional way [1 min of topical anaesthesia and local infiltration] Experimental group: A Buzzy external cold and vibrating device will be used on the site of application [right/left face] 2 minutes before anaesthesia and this application will be maintained throughout the injection.
At the first visit, the children in Group A will receive the control intervention and those in group B will receive the experimental intervention. A wash out period of 7 days was observed, after which the second visit will be scheduled. At the second visit, the children in Group A will receive the experimental intervention and Group B will receive the control intervention. Demographic details, informed consent from the parents, and assent from the children will be obtained before the commencement of the study. Outcomes will be recorded as primary and secondary outcomes. primary outcomes includes FLACC, WBS and parental scale where as secondary outcomes will be pulse rate and Frankel behaviour rating scale.
Pulse rate will be recorded before anaesthesia, during anaesthesia and 1 min after delivery of anaesthesia, Frankel behaviour rating scale will be measured before, during and after anaesthesia procedures. FLACC and WBS scales will be used to objectively and subjectively record the pain perception. parental scale will be used to determine parental view regarding pain scale during anaesthesia procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BUZZY BEE | Experimental | Device: BUZZY BEE [ Vibrating device]Vibrating device |
| Conventional technique | Active comparator | Device: Conventional techniqueconventional way |
Who may qualify
- Ages
- 7 to 9 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Healthy children with no systemic illness, allergies
- Co-operative child
- Patient requiring block for dental treatment
- children with proper parental consent Exclusion criteria
- 1. Children with systemic illness and allergy 2. Un co-operative child
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| BUZZY BEE [ Vibrating device]Also: EXPERIMENTALalready described | Device | BUZZY BEE |
| Conventional techniquedescribed | Device | Conventional technique |
Primary outcome
SEM
Time frame: During the delivery of anesthesia
Sound, Eye, Motor
WBS
Time frame: During the delivery of anesthesia
WONG BAKER SCALE
parental scale
Time frame: after administration of anesthesia
PARENTAL SCALE
2 secondary outcomes
PULSE RATE
Time frame: Measured three times. 15 minutes before the delivery of anesthesia, b. At the time of delivery of anesthesia and c. 1 minute after the delivery of anesthesia
BEHAVIOURAL RATING SCALE
Time frame: Measured three times. 15 minutes before the delivery of anesthesia, b. At the time of delivery of anesthesia and c. 1 minute after the delivery of anesthesia
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 9 Mar 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BUZZY BEE [ Vibrating device] and Conventional technique in people with Pain Management, run by University of Jazan at 1 site in Saudi Arabia.
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 5 inclusion and 0 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: enrolling by invitation, as of the sponsor's last update on 9 Mar 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 Saudi Arabia. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SEM (time frame: During the delivery of anesthesia). The study lists 3 primary outcomes in all. 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 9 Mar 2026.