HealthyNCT07306650
Effect of Vibrasthetic Device on Pain Reduction During Local Anesthesia in Pediatric Patients
A study testing Vibrating device and Manual vibration in people with Healthy and Behavior Management, run by King Abdulaziz University at 1 site in Saudi Arabia.
Trial summary
The goal of this clinical trial is to test if children aged between 6 and 14 years who are receiving a dental injection will feel less pain by using a vibration device applied to the injection site during the injection compared to vibrating the lip using only the researcher's hands without using the vibration device. Read more about this study
- Who is it for?
- Ages 6 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Behavior Management
- What is being tested?
- Vibrating device and Manual vibration
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 26 Dec 2025to Jun 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 6 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children aged 6-14 years
- who have previously received local anesthesia
- and whose behavior, according to the Frankl scale, was positive or definitely positive
- and the absence of systemic diseases or known allergies to local anesthetic agents
Who cannot join
- Uncooperative children
- Children with special healthcare needs
- Children with conditions affecting pain perception
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Saudi Arabia1 site
King Abdulaziz University Dental Hospital
Jeddah
Mariam B Aldajani, 00966-567808848, mariam.aldajani@gmail.com
mariam.aldajani@gmail.com
About this study
Official title: Effect of Vibrasthetic Vibration Device on Pain Reduction During Local Anesthesia in Pediatric Patients: A Randomized Clinical Study
The goal of this clinical trial is to test if children aged between 6 and 14 years who are receiving a dental injection will feel less pain by using a vibration device applied to the injection site during the injection compared to vibrating the lip using only the researcher's hands without using the vibration device. It will also test if this device makes them feel less anxious during the injection. The main question it aims to answer is:
Does using the Vibrasthetic device make dental injections more comfortable for children? Researchers will compare the effect of using this vibration device versus using their hands for manual vibration of the lip in the same child.
Read more
Participants will:
- Experience one method of vibration during their visit to the dentist (either the vibration device or manual vibration).
- then after 2 weeks they will go to the same dentist again and experience the other method of vibration.
- Receive the dental treatment they need in both visits. Participants will be asked to rate the pain they felt after the injection. This will be done by the participants choosing one of 6 pictures we will show them. Each picture explains the level of the pain they felt, and each picture has a score. We will score the pain the participants felt by looking at which picture they chose to describe their pain from the injection.
Read the detailed description
Each participant will start their dental appointment by them sitting on a chair beside the dental chair and having their heart rate recorded by a pulse oximeter for baseline comfort level. They will be randomly assigned to either receive the vibration using the Vibrasthetic vibration device or by the dentist researcher manually vibrating the participant's lip during the injection. Topical anesthesia will be applied on the injection site and then they will receive the dental injection along with experiencing vibration in the area of the dental injection administered. Immediately after the injection, the participant will rate the pain intensity felt during the injection using validated Pain Scale (Wong-Baker). During the injection, a separate researcher, called the monitor, will monitor the participant's pain using the FLACC scale (Face, Legs, Activity, Cry, Consolability). Also, the monitor will record the participant's behavior using the Frankl scale, after which the participant will receiver their needed dental treatment. In the following visit, the participant will receive the other vibration method before their dental treatment with the recording of the same metrics by the researchers.
- Conditions
- Healthy, Behavior Management
- Being tested
- Vibrating device, Manual vibration
- Keywords
- Vibrasthetic, Vibration, child behavior management, local anesthesia, pediatric dentistry
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vibrating deviceDevice
Battery powered, no need to replace vibrating head of the unit (only a plastic barrier is required to cover the device), not investigated before.
Manual vibrationProcedure or surgery
The operator will hold the participant's lip between their forefinger and thumb to manually vibrate the lip and hence vibrating the injection site.
| Study group | Role | What they receive |
|---|---|---|
| Device | Experimental | This group will experience receiving a dental injection while the operator uses a vibrating device (Vibrasthetic) to vibrate the injection site. Receives: Device: Vibrating device |
| Manual | Active comparator | Our study is a crossover study, so the participants will receive the dental injection while the operator manually vibrates their lip by holding the lip between their forefinger and thumb (control). The partcipants will be randomized, so phase I for the participants may be either the device or manual, and phase II will be the other method of vibration not used in phase I. Receives: Procedure: Manual vibration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain level
Measured subjectively using an Arabic validated Wong-Baker Faces Pain Rating Scale by the participant choosing the picture that best describes the pain they felt. Minimum score is zero, maximum score is 10. Score of zero is the best outcome, which translates into "No hurt = no pain felt". Score of 10 is the worst outcome, which translates into "Hurts most = severe pain felt"
Measured: Participant will record the level of pain felt immediately after receiving the injection. This usually occurs around 10 mins after the start of the appointment.
Pain level
Measured objectively using Face, Legs, Activity, Cry, Consolability (FLACC) scale. The investigator monitoring the participant will record the participant's reaction while receiving the injection. Minimum score is zero, maximum score is 10. A score of zero is the best outcome, and a score of 10 is the worst outcome.
Measured: Participant pain will be recorded by the investigator monitoring the participant using the scale while the patient is receiving the injection. This usually occurs around 10 mins after the start of the appointment.
Pain level
Measured using a pulse oxymeter placed on the participant's forefinger. Pulse rate will be recorded before the participant sits on the dental chair (while they are sitting on a chair next to the dental chair) to measure baseline heart rate. Then pulse rate will be recorded again immediately by the investigator monitoring the participant after the participant receives the injection.
Measured: This metric will be measured from the start of the appointment until the participant receives the injection. This will usually take around 10 minutes.
Secondary outcomes (1)
Behavior and cooperation
Measured using Frankl behavior scale. The investigator monitoring the participant will record the participant's behavior during and after receiving the injection. Behavior can be scored as definitely negative (--), negative (-), positive (+), or definitely positive (++). A score of (--) is the worst outcome, and a score of (++) is the best outcome.
Measured: This metric is measured by judging the participant's behavior, and is recorded after the injection is given. This will take around 10 mins from the start of the appointment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2025
- Study start26 Dec 2025 (estimated)
- Primary completionMar 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King Abdulaziz University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mariam Aldajani, King Abdulaziz University
- Investigators
- Mariam B Aldajani, Principal investigator, King Abdulaziz University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07306650
- Sponsor's protocol ID
- 96-06-25
- Status last verified
- Dec 2025
- First submitted
- 14 Dec 2025
- Last updated
- 2 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ching D, Finkelman M, Loo CY. Effect of the DentalVibe injection system on pain during local anesthesia injections in adolescent patients. Pediatr Dent. 2014 Jan-Feb;36(1):51-5.
PubMed 24717710Oliveira MA, Bendo CB, Ferreira MC, Paiva SM, Vale MP, Serra-Negra JM. Association between childhood dental experiences and dental fear among dental, psychology and mathematics undergraduates in Brazil. Int J Environ Res Public Health. 2012 Dec 17;9(12):4676-87. doi: 10.3390/ijerph9124676.
PubMed 23247225Kadam, N. S., Hegde, A. M., & Sharma, A. (2024). Comparative evaluation of anxiety levels in children using distraction techniques: An assessment with Venham Picture Test and pulse oximeter. Journal of Scientific Dentistry, 12(2), 95-101
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Vibrasthetic Vibration Device on Pain Reduction During Local Anesthesia in Pediatric Patients: A Randomized Clinical Study
- ClinicalTrials.gov ID
- NCT07306650
- Acronym / sponsor ID
- 96-06-25
- Conditions
- Healthy, Behavior Management
- Keywords
- Vibrasthetic, Vibration, child behavior management, local anesthesia, pediatric dentistry
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- King Abdulaziz UniversityUniversity, hospital or other
- Study start
- 26 Dec 2025 (estimated)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 29 Dec 2025 (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.
The goal of this clinical trial is to test if children aged between 6 and 14 years who are receiving a dental injection will feel less pain by using a vibration device applied to the injection site during the injection compared to vibrating the lip using only the researcher's hands without using the vibration device. It will also test if this device makes them feel less anxious during the injection. The main question it aims to answer is:
Does using the Vibrasthetic device make dental injections more comfortable for children? Researchers will compare the effect of using this vibration device versus using their hands for manual vibration of the lip in the same child.
Participants will:
- Experience one method of vibration during their visit to the dentist (either the vibration device or manual vibration).
- then after 2 weeks they will go to the same dentist again and experience the other method of vibration.
- Receive the dental treatment they need in both visits. Participants will be asked to rate the pain they felt after the injection. This will be done by the participants choosing one of 6 pictures we will show them. Each picture explains the level of the pain they felt, and each picture has a score. We will score the pain the participants felt by looking at which picture they chose to describe their pain from the injection.
Detailed description
Each participant will start their dental appointment by them sitting on a chair beside the dental chair and having their heart rate recorded by a pulse oximeter for baseline comfort level. They will be randomly assigned to either receive the vibration using the Vibrasthetic vibration device or by the dentist researcher manually vibrating the participant's lip during the injection. Topical anesthesia will be applied on the injection site and then they will receive the dental injection along with experiencing vibration in the area of the dental injection administered. Immediately after the injection, the participant will rate the pain intensity felt during the injection using validated Pain Scale (Wong-Baker). During the injection, a separate researcher, called the monitor, will monitor the participant's pain using the FLACC scale (Face, Legs, Activity, Cry, Consolability). Also, the monitor will record the participant's behavior using the Frankl scale, after which the participant will receiver their needed dental treatment. In the following visit, the participant will receive the other vibration method before their dental treatment with the recording of the same metrics by the researchers.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Device | Experimental | Device: Vibrating deviceThis group will experience receiving a dental injection while the operator uses a vibrating device (Vibrasthetic) to vibrate the injection site. |
| Manual | Active comparator | Procedure: Manual vibrationOur study is a crossover study, so the participants will receive the dental injection while the operator manually vibrates their lip by holding the lip between their forefinger and thumb (control). The partcipants will be randomized, so phase I for the participants may be either the device or manual, and phase II will be the other method of vibration not used in phase I. |
Who may qualify
- Ages
- 6 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Children aged 6-14 years
- who have previously received local anesthesia
- and whose behavior, according to the Frankl scale, was positive or definitely positive
- and the absence of systemic diseases or known allergies to local anesthetic agents
Key exclusion criteria (3 listed)
- Uncooperative children
- Children with special healthcare needs
- Children with conditions affecting pain perception
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 |
|---|---|---|
| Vibrating deviceBattery powered, no need to replace vibrating head of the unit (only a plastic barrier is required to cover the device), not investigated before. | Device | Device |
| Manual vibrationThe operator will hold the participant's lip between their forefinger and thumb to manually vibrate the lip and hence vibrating the injection site. | Procedure or surgery | Manual |
Primary outcome
Pain level
Time frame: Participant will record the level of pain felt immediately after receiving the injection. This usually occurs around 10 mins after the start of the appointment.
Measured subjectively using an Arabic validated Wong-Baker Faces Pain Rating Scale by the participant choosing the picture that best describes the pain they felt. Minimum score is zero, maximum score is 10. Score of zero is the best outcome, which translates into "No hurt = no pain felt". Score of 10 is the worst outcome, which translates into "Hurts most = severe pain felt"
Pain level
Time frame: Participant pain will be recorded by the investigator monitoring the participant using the scale while the patient is receiving the injection. This usually occurs around 10 mins after the start of the appointment.
Measured objectively using Face, Legs, Activity, Cry, Consolability (FLACC) scale. The investigator monitoring the participant will record the participant's reaction while receiving the injection. Minimum score is zero, maximum score is 10. A score of zero is the best outcome, and a score of 10 is the worst outcome.
Pain level
Time frame: This metric will be measured from the start of the appointment until the participant receives the injection. This will usually take around 10 minutes.
Measured using a pulse oxymeter placed on the participant's forefinger. Pulse rate will be recorded before the participant sits on the dental chair (while they are sitting on a chair next to the dental chair) to measure baseline heart rate. Then pulse rate will be recorded again immediately by the investigator monitoring the participant after the participant receives the injection.
1 secondary outcome
Behavior and cooperation
Time frame: This metric is measured by judging the participant's behavior, and is recorded after the injection is given. This will take around 10 mins from the start of the appointment.
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 2 Jan 2026.
- Background: PubMed 24717710Ching D, Finkelman M, Loo CY. Effect of the DentalVibe injection system on pain during local anesthesia injections in adolescent patients. Pediatr Dent. 2014 Jan-Feb;36(1):51-5.
- Background: PubMed 23247225Oliveira MA, Bendo CB, Ferreira MC, Paiva SM, Vale MP, Serra-Negra JM. Association between childhood dental experiences and dental fear among dental, psychology and mathematics undergraduates in Brazil. Int J Environ Res Public Health. 2012 Dec 17;9(12):4676-87. doi: 10.3390/ijerph9124676.
- BackgroundKadam, N. S., Hegde, A. M., & Sharma, A. (2024). Comparative evaluation of anxiety levels in children using distraction techniques: An assessment with Venham Picture Test and pulse oximeter. Journal of Scientific Dentistry, 12(2), 95-101
- 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.
Mariam B Aldajani principal investigator
King Abdulaziz 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 Vibrating device and Manual vibration in people with Healthy and Behavior Management, run by King Abdulaziz University 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 4 inclusion and 3 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 2 Jan 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?
Contact Mariam B Aldajani, Master of Dental Science (MDS) (00966-567808848, maldajani@kau.edu.sa), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain level (time frame: Participant will record the level of pain felt immediately after receiving the injection. This usually occurs around 10 mins after the start of the appointment.). 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?
On the ClinicalTrials.gov record for NCT07306650, which also lists 3 linked publications.
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 2 Jan 2026.