Local AnaestheticNCT03953001
Effect of a Vibration System on Pain Reduction During Injection of Local Dental Anaesthesia in Children
A study testing Adminstration Technique using Buzzy external distractor, 2% Lidocaine with 1:50,000 epinephrine and Topical Anesthetic in people with Local Anaesthetic and Dental Anxiety, run by Imam Abdulrahman Bin Faisal University at 1 site in Saudi Arabia.
Trial summary
The study assesses the effect of a new vibration system on pain reduction during the injection of local anesthesia. Children undergoing dental treatment are allocated to two groups; one receiving the Buzz, a vibration system and another group receiving nothing. Read more about this study
- Who is it for?
- Ages 5 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Local Anaesthetic, Dental Anxiety
- What is being tested?
- Adminstration Technique using Buzzy external distractor, 2% Lidocaine with 1:50,000 epinephrine and Topical Anesthetic
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 1 Jan 2018to 1 Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 5 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children 5-12 years of age.
- Positive or definitely positive behavior on Frankl scale.6
- Children receiving treatment on the dental chair.
- Free from allergies to topical anesthetic used in the study.
- Parental consent for child participation in the study.
Who cannot join
- Those in need of treatment under general anesthesia will be excluded from the study.
- Children with allergies from topical anesthesia
Trial locations and contacts
1 site in 1 country.
Saudi Arabia1 site
imam adbulrahman Bin Faisal University- College of Dentistry
Dammam, 32412
About this study
Official title: Effect of a Vibration System on Pain Reduction During Injection of Local Dental Anaesthesia in Children: a Randomized Controlled Clinical Trial
The study assesses the effect of a new vibration system on pain reduction during the injection of local anesthesia. Children undergoing dental treatment are allocated to two groups; one receiving the Buzz, a vibration system and another group receiving nothing. Pain during injection of local anesthetic is assessed using a validated tool in addition to assessment of child cooperation during treatment.
Read the detailed description
Eligibility of children for inclusion into the study will be assessed followed by random sequence generation and randomization into one of the two study group and allocation concealment. Topical anaesthesia will be administered to the two groups followed by implementation of the vibration system in the test group. . Behavior and pain will assessed at the time of injection.
- Conditions
- Local Anaesthetic, Dental Anxiety
- Being tested
- Adminstration Technique using Buzzy external distractor, 2% Lidocaine with 1:50,000 epinephrine, Topical Anesthetic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adminstration Technique using Buzzy external distractorDevice
External application of Buzzy distractor during administration of dental anesthetic
2% Lidocaine with 1:50,000 epinephrineDrug
Local Dental anesthetic infiltration
Topical AnestheticDrug
20% Benzocaine gel was applied on the area of infiltration
| Study group | Role | What they receive |
|---|---|---|
| Buzzy | Experimental | Buzzy was used during Maxillary anesthetic infiltration injection with 2%lidocaine with 1:50,000 epinephrine after topical application with 20% Benzocaine topical gel. Receives: Device: Adminstration Technique using Buzzy external distractor; Drug: 2% Lidocaine with 1:50,000 epinephrine; Drug: Topical Anesthetic |
| Control | Active comparator | Maxillary anesthetic infiltration injection with 2%lidocaine with 1:50,000 epinephrine after topical application with 20% Benzocaine topical gel only. Receives: Drug: 2% Lidocaine with 1:50,000 epinephrine; Drug: Topical Anesthetic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self Reported pain intensity: Visual analogue scale (VAS) of pain intensity
Self reported pain intensity before the injection and directly after the injection. Each child scored pain intensity twice, one before the injection and one directly after the injection (0=no pain; 10=Very painful).
Measured: Procedure (immediately after the administration of Dental anesthesia)
Secondary outcomes (3)
Parents Perception for the child tolerance of pain; Observational Pain rating scale
The parents were asked about the reaction and attitude of the child during the dental anesthesia administration. Parents rated the child ability to tolerate pain with (0=Didn't Tolerate and 10= Tolerated with a smile)
Measured: Procedure (immediately after the administration of Dental anesthesia.)
External observation for Facial and Physical expression. Using Sounds, Eyes, and Motor (SEM) scale (RANGE 0-9).
Video was recorded for each child before, during and after the administration of local anesthesia. Each video was assessed by an external calibrated evaluator to score each child response. SEM (0=Comfortable, with no sound, no eye signs of discomfort and Hands are relaxed, no apparent body tenseness, 9= Painful, with verbal complain, crying tears and moving the hands to make aggressive physical contact and pulling the head away. The lowest record mean the child was comfortable and the higher the score mean the child experienced discomfort.
Measured: Procedure (immediately during and after the administration of Dental anesthesia.)
Faces Legs Activity Cry Consolability (FLACC) Scale (RANGE 0-10)
Video was recorded for each child before, during and after the administration of local anesthesia. Each video was assessed by an external calibrated evaluator to score each child response. FLACC (0=The child did not express any facial discomfort with normal legs position no abnormal activity, not crying and relaxed. The highest score 10= Child experienced discomfort, moving his legs jerking crying and difficult to console. The lowest record mean the child was comfortable and the higher the score mean the child experienced discomfort.
Measured: Procedure (immediately during and after the administration of Dental anesthesia.)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2019
- Study start1 Jan 2018
- Primary completion1 Apr 2018
- Study completion1 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Local AnaestheticStudies 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imam Abdulrahman Bin Faisal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jehan AlHumaid, Imam Abdulrahman Bin Faisal University
- Investigators
- Jehan A AlHumaid, DSc, Principal investigator, imam Abdulrahman Bin Faisal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03953001
- Sponsor's protocol ID
- JH123456
- Status last verified
- May 2019
- First submitted
- 29 Mar 2019
- Last updated
- 16 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
AlHareky M, AlHumaid J, Bedi S, El Tantawi M, AlGahtani M, AlYousef Y. Effect of a Vibration System on Pain Reduction during Injection of Dental Anesthesia in Children: A Randomized Clinical Trial. Int J Dent. 2021 Jan 30;2021:8896408. doi: 10.1155/2021/8896408. eCollection 2021.
PubMed 33564311
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Vibration System on Pain Reduction During Injection of Local Dental Anaesthesia in Children: a Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT03953001
- Acronym / sponsor ID
- JH123456
- Conditions
- Local Anaesthetic, Dental Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Imam Abdulrahman Bin Faisal UniversityUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 1 Apr 2018 (actual)
- Study completion
- 1 Jun 2018 (actual)
- First posted
- 16 May 2019 (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 study assesses the effect of a new vibration system on pain reduction during the injection of local anesthesia. Children undergoing dental treatment are allocated to two groups; one receiving the Buzz, a vibration system and another group receiving nothing. Pain during injection of local anesthetic is assessed using a validated tool in addition to assessment of child cooperation during treatment.
Detailed description
Eligibility of children for inclusion into the study will be assessed followed by random sequence generation and randomization into one of the two study group and allocation concealment. Topical anaesthesia will be administered to the two groups followed by implementation of the vibration system in the test group. . Behavior and pain will assessed at the time of injection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Buzzy | Experimental | Device: Adminstration Technique using Buzzy external distractor, Drug: 2% Lidocaine with 1:50,000 epinephrine, Drug: Topical AnestheticBuzzy was used during Maxillary anesthetic infiltration injection with 2%lidocaine with 1:50,000 epinephrine after topical application with 20% Benzocaine topical gel. |
| Control | Active comparator | Drug: 2% Lidocaine with 1:50,000 epinephrine, Drug: Topical AnestheticMaxillary anesthetic infiltration injection with 2%lidocaine with 1:50,000 epinephrine after topical application with 20% Benzocaine topical gel only. |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Children 5-12 years of age.
- Positive or definitely positive behavior on Frankl scale.6
- Children receiving treatment on the dental chair.
- Free from allergies to topical anesthetic used in the study.
- Parental consent for child participation in the study.
Key exclusion criteria (2 listed)
- Those in need of treatment under general anesthesia will be excluded from the study.
- Children with allergies from topical anesthesia
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 |
|---|---|---|
| Adminstration Technique using Buzzy external distractorExternal application of Buzzy distractor during administration of dental anesthetic | Device | Buzzy |
| 2% Lidocaine with 1:50,000 epinephrineLocal Dental anesthetic infiltration | Drug | Buzzy, Control |
| Topical Anesthetic20% Benzocaine gel was applied on the area of infiltration | Drug | Buzzy, Control |
Primary outcome
Self Reported pain intensity: Visual analogue scale (VAS) of pain intensity
Time frame: Procedure (immediately after the administration of Dental anesthesia)
Self reported pain intensity before the injection and directly after the injection. Each child scored pain intensity twice, one before the injection and one directly after the injection (0=no pain; 10=Very painful).
3 secondary outcomes
Parents Perception for the child tolerance of pain; Observational Pain rating scale
Time frame: Procedure (immediately after the administration of Dental anesthesia.)
External observation for Facial and Physical expression. Using Sounds, Eyes, and Motor (SEM) scale (RANGE 0-9).
Time frame: Procedure (immediately during and after the administration of Dental anesthesia.)
Faces Legs Activity Cry Consolability (FLACC) Scale (RANGE 0-10)
Time frame: Procedure (immediately during and after the administration of Dental anesthesia.)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2019.
- Derived from this study: PubMed 33564311AlHareky M, AlHumaid J, Bedi S, El Tantawi M, AlGahtani M, AlYousef Y. Effect of a Vibration System on Pain Reduction during Injection of Dental Anesthesia in Children: A Randomized Clinical Trial. Int J Dent. 2021 Jan 30;2021:8896408. doi: 10.1155/2021/8896408. eCollection 2021.
- 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. This study is not recruiting at the moment.
Jehan A AlHumaid, DSc principal investigator
imam Abdulrahman Bin Faisal
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adminstration Technique using Buzzy external distractor, 2% Lidocaine with 1:50,000 epinephrine and Topical Anesthetic in people with Local Anaesthetic and Dental Anxiety, run by Imam Abdulrahman Bin Faisal 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 5 inclusion and 2 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: finished, as of the sponsor's last update on 16 May 2019. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Self Reported pain intensity: Visual analogue scale (VAS) of pain intensity (time frame: Procedure (immediately after the administration of Dental anesthesia)). 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 NCT03953001, which also lists 1 linked publication.
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 16 May 2019.