Dental Caries in ChildrenNCT06290531
Different Methods for Reducing Buccal Infiltration Local Anesthesia Injection Pain
A study testing Buzzy device (cold and vibration), Buzzy device (vibration only) and precooling in people with Dental Caries in Children, run by Cairo University at 1 site in Egypt.
Trial summary
Local anesthetic injection is considered one of the most annoying dental procedures. The use of topical anesthesia is considered a routine procedure in the dental clinic especially for children. However, the taste and application procedure of the topical gel may not be pleasant for all children. Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries in Children
- What is being tested?
- Buzzy device (cold and vibration), Buzzy device (vibration only) and precooling
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteEgypt
- Study dates
- 16 Jan 2022to 28 Sep 2023
- 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 6 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children in the mixed dentition stage,
- Age range 6-12 years old,
- Need extraction to a maxillary molar,
- Cooperative and medically free.
Who cannot join
- Exclusion will be performed if the parent refused the participation of their children in the research.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Pediatric Dentistry and Dental Public Health, Faculty of Dentistry, Cairo University
Cairo, 11559
About this study
Official title: Different Methods for Reducing Buccal Infiltration Local Anesthesia Injection Pain in Children: A Randomized Controlled Study.
Local anesthetic injection is considered one of the most annoying dental procedures. The use of topical anesthesia is considered a routine procedure in the dental clinic especially for children. However, the taste and application procedure of the topical gel may not be pleasant for all children.
The introduction of the Buzzy device is considered a distraction measure in the medical field. Alanazi et al., 2019, studied the effect of using the Buzzy device with cold and vibration compared to the conventional infiltration technique using 30-gauge needle. They concluded that the use of the Buzzy device resulted in better patients' acceptance and significantly lower Wong-Baker scores.
Ballard et al., 2019, mentioned in their systematic review the efficacy of the Buzzy device for pain management during needle-related procedures, they concluded that the use of the device may be promising. Ghaderi et al., 2013, evaluated the effect of cooling the injection site on pain perception before infiltration of local anesthetics. They found that cooling the injection site before infiltration of local anesthetics in the buccal mucosa for 1 min, reduced pain perceived by pediatric patients.
Read the detailed description
The investigators used the topical anesthesia, Buzzy device (using vibration only and using cold and vibration) or precooling on pain during buccal infiltration local anesthesia injection.
- Conditions
- Dental Caries in Children
- Being tested
- Buzzy device (cold and vibration), Buzzy device (vibration only), precooling, Flavored Benzocaine topical anesthetic gel 20%
- Keywords
- Local Anesthesia, Buzzy, Topical Anesthesia, Pain, precooling
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Buzzy device (cold and vibration)Device
The device produces cold and vibration to act on the gate control theory and provide painless injection by nerve distraction
Buzzy device (vibration only)Device
The device produces vibration to act on the gate control theory and provide painless injection by nerve distraction
precoolingOther
Ice cubes used for applying coolness at the injection area
Flavored Benzocaine topical anesthetic gel 20%Other
Topical anesthetic gel
| Study group | Role | What they receive |
|---|---|---|
| Buzzy device (cold and vibration) | Experimental | Not described Receives: Device: Buzzy device (cold and vibration) |
| Buzzy device (vibration only) | Experimental | Not described Receives: Device: Buzzy device (vibration only) |
| Precooling | Experimental | Not described Receives: Other: precooling |
| Flavored Benzocaine topical anesthetic gel 20% | Active comparator | Not described Receives: Other: Flavored Benzocaine topical anesthetic gel 20% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient reported pain during needle injection
Patient was asked to choose from the faces on the Wong Baker faces pain rating scale (0-10) with 10 is the worst score
Measured: Immediately post injection
Secondary outcomes (4)
Child behaviour during needle injection
Child behaviour during needle injection was recorded using Sound-eye-motor scale (0-9) with 9 is the worst score
Measured: Immediately during injection
Heart rate
Heart rate was recorded using pulse oximetry (beats/minute)
Measured: Immediately post injection
Oxygen saturation
Oxygen saturation was recorded using pulse oximetry
Measured: Immediately post injection
Child and parent satisfaction
By asking questions to both child and their parent on a likert scale for children ( positive, neutral and negative) for parents ( strongly agree, agree, no opinion, disagree and strongly disagree)
Measured: Immediately post injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2024
- Study start16 Jan 2022
- Primary completion28 Sep 2023
- Study completion28 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental Caries in ChildrenStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatma Abdelgawad, Cairo University
- Investigators
- Fatma KI Abdelgawad, PhD, Principal investigator, Associate Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06290531
- Sponsor's protocol ID
- CEBD-CU-2023-11-12
- Status last verified
- Feb 2024
- First submitted
- 29 Jan 2024
- Last updated
- 4 Mar 2024
- 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 4 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Different Methods for Reducing Buccal Infiltration Local Anesthesia Injection Pain in Children: A Randomized Controlled Study.
- ClinicalTrials.gov ID
- NCT06290531
- Acronym / sponsor ID
- CEBD-CU-2023-11-12
- Conditions
- Dental Caries in Children
- Keywords
- Local Anesthesia, Buzzy, Topical Anesthesia, Pain, precooling
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 16 Jan 2022 (actual)
- Primary completion
- 28 Sep 2023 (actual)
- Study completion
- 28 Sep 2023 (actual)
- First posted
- 4 Mar 2024 (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.
Local anesthetic injection is considered one of the most annoying dental procedures. The use of topical anesthesia is considered a routine procedure in the dental clinic especially for children. However, the taste and application procedure of the topical gel may not be pleasant for all children.
The introduction of the Buzzy device is considered a distraction measure in the medical field. Alanazi et al., 2019, studied the effect of using the Buzzy device with cold and vibration compared to the conventional infiltration technique using 30-gauge needle. They concluded that the use of the Buzzy device resulted in better patients' acceptance and significantly lower Wong-Baker scores.
Ballard et al., 2019, mentioned in their systematic review the efficacy of the Buzzy device for pain management during needle-related procedures, they concluded that the use of the device may be promising. Ghaderi et al., 2013, evaluated the effect of cooling the injection site on pain perception before infiltration of local anesthetics. They found that cooling the injection site before infiltration of local anesthetics in the buccal mucosa for 1 min, reduced pain perceived by pediatric patients.
Detailed description
The investigators used the topical anesthesia, Buzzy device (using vibration only and using cold and vibration) or precooling on pain during buccal infiltration local anesthesia injection.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Buzzy device (cold and vibration) | Experimental | Device: Buzzy device (cold and vibration) |
| Buzzy device (vibration only) | Experimental | Device: Buzzy device (vibration only) |
| Precooling | Experimental | Other: precooling |
| Flavored Benzocaine topical anesthetic gel 20% | Active comparator | Other: Flavored Benzocaine topical anesthetic gel 20% |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Children in the mixed dentition stage,
- Age range 6-12 years old,
- Need extraction to a maxillary molar,
- Cooperative and medically free.
Key exclusion criteria (1 listed)
- Exclusion will be performed if the parent refused the participation of their children in the research.
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 device (cold and vibration)The device produces cold and vibration to act on the gate control theory and provide painless injection by nerve distraction | Device | Buzzy device (cold and vibration) |
| Buzzy device (vibration only)The device produces vibration to act on the gate control theory and provide painless injection by nerve distraction | Device | Buzzy device (vibration only) |
| precoolingIce cubes used for applying coolness at the injection area | Other | Precooling |
| Flavored Benzocaine topical anesthetic gel 20%Topical anesthetic gel | Other | Flavored Benzocaine topical anesthetic gel 20% |
Primary outcome
Patient reported pain during needle injection
Time frame: Immediately post injection
Patient was asked to choose from the faces on the Wong Baker faces pain rating scale (0-10) with 10 is the worst score
4 secondary outcomes
Child behaviour during needle injection
Time frame: Immediately during injection
Heart rate
Time frame: Immediately post injection
Oxygen saturation
Time frame: Immediately post injection
Child and parent satisfaction
Time frame: Immediately post injection
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 4 Mar 2024.
- 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.
Fatma KI Abdelgawad, PhD principal investigator
Associate Professor
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 device (cold and vibration), Buzzy device (vibration only) and precooling in people with Dental Caries in Children, 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 4 inclusion and 1 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 4 Mar 2024. 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?
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?
Patient reported pain during needle injection (time frame: Immediately post 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 4 Mar 2024.