Anesthesia, LocalNCT05857033
Cold Vibratory Stimuli on Pain Perception Governing Infiltration Anesthesia in in Children
A study testing Buccal and direct palatal injection with the aid of Buzzy, Buccal and indirect palatal injection with the aid of Buzzy and Buccal and direct palatal injection without Buzzy in people with Anesthesia, Local, run by Alexandria University at 1 site in Egypt.
Trial summary
Local anesthesia injections are sometimes painful, resulting in antagonistic cooperation, fear, and anxiety in children. This study aims to investigate the effectiveness of vibratory and cold stimulation before the injection to reduce pain. Read more about this study
- Who is it for?
- Ages 5 to 8 years
- Conditions the study is for
- Anesthesia, Local
- What is being tested?
- Buccal and direct palatal injection with the aid of Buzzy, Buccal and indirect palatal injection with the aid of Buzzy and Buccal and direct palatal injection without Buzzy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteEgypt
- Study dates
- 5 Jan 2023to 20 May 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 5 to 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients who are in need of extraction of maxillary posterior teeth.
- Children free of any systemic disease or special health care needs (ASA I).
- Children with no learning disabilities.
- Positive or definitely positive behavior during preoperative assessments according to the Frankl Scale.
- Patients whose parents will give consent to participate.
Who cannot join
- Having active sites of pathosis in the area of injection that could affect the anesthetic assessment.
- Signs of reversible pulpitis.
- Restorable tooth.
- Patients allergic to local anesthesia or having a family history of allergy to local anesthesia.
- Patients with acute oral or facial infection (swelling and/or cellulites )
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Cold Vibratory Stimuli on Pain Perception Governing Infiltration Anesthesia in the Maxillary Arch in Children: a Randomized Controlled Clinical Trial
Local anesthesia injections are sometimes painful, resulting in antagonistic cooperation, fear, and anxiety in children. This study aims to investigate the effectiveness of vibratory and cold stimulation before the injection to reduce pain. Purpose of the study: Evaluate the effectiveness of Buzzy® in pain reduction during local anesthesia administration compared to the traditional topical anesthetic gel in pediatric patients.
- Conditions
- Anesthesia, Local
- Being tested
- Buccal and direct palatal injection with the aid of Buzzy, Buccal and indirect palatal injection with the aid of Buzzy, Buccal and direct palatal injection without Buzzy, Buccal and indirect palatal injection without Buzzy
- Keywords
- Dental injection, Palatal injection, Indirect palatal injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Buccal and direct palatal injection with the aid of BuzzyOther
Children are assigned to local anesthesia after using the Buzzy vibration unit extraorally for 2 minutes using buccal and direct palatal injection
Buccal and indirect palatal injection with the aid of BuzzyOther
Children are assigned to local anesthesia after using the Buzzy vibration unit extraorally for 2 minutes using buccal and indirect palatal injection
Buccal and direct palatal injection without BuzzyOther
Children are assigned to local anesthesia after using topical analgesic gel (benzocaine 20%) intraorally for 1 minute using buccal and direct palatal injection
Buccal and indirect palatal injection without BuzzyOther
Children are assigned to local anesthesia after using topical analgesic gel (benzocaine 20%) intraorally for 1 minute using buccal and indirect palatal injection
| Study group | Role | What they receive |
|---|---|---|
| Direct local anesthesia with Buzzy | Experimental | Not described Receives: Other: Buccal and direct palatal injection with the aid of Buzzy |
| Indirect local anesthesia with Buzzy | Experimental | Not described Receives: Other: Buccal and indirect palatal injection with the aid of Buzzy |
| Direct local anesthesia | Active comparator | Not described Receives: Other: Buccal and direct palatal injection without Buzzy |
| Indirect local anesthesia | Active comparator | Not described Receives: Other: Buccal and indirect palatal injection without Buzzy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pain scores
Visual Analogue Scale is used and it ranges from 0 to 10. the ''0'' point indicates ''no pain'' and ''10'' point indicates the worst possible pain.
Measured: Baseline and up to 1 hour
Change in child's behavior
Sound, eye,motor (SEM) scale is used. it assess child's pain perception by observing discomfot levels on SEM during injections.
Total scores for SEM range from 0 to 9 based on 0-3 score for each parameter. Score 0: Comfort Score 1: Mild disocomfort Score 2: Moderate discomfort Score 3: Severe discomfort
Measured: During the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2023
- Study start5 Jan 2023
- Primary completion20 May 2023 (estimated)
- Study completion20 May 2023 (estimated)
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 Anesthesia, LocalStudies of the same condition, open and under way.
- More trials run by Alexandria 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
- Model description
- The Participants will be randomly and equally allocated into 2 groups with 2 subgroups each
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05857033
- Sponsor's protocol ID
- 0568-12/2022
- Status last verified
- Apr 2023
- First submitted
- 26 Apr 2023
- Last updated
- 12 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hambouta HM, Sharaf DA, Wahba NA. Effectiveness of cold vibratory stimuli on pain perception governing infiltration anesthesia in the maxillary arch in children: a randomized controlled clinical trial. BMC Oral Health. 2025 Jun 3;25(1):900. doi: 10.1186/s12903-025-06170-4.
PubMed 40462040
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Cold Vibratory Stimuli on Pain Perception Governing Infiltration Anesthesia in the Maxillary Arch in Children: a Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT05857033
- Acronym / sponsor ID
- 0568-12/2022
- Conditions
- Anesthesia, Local
- Keywords
- Dental injection, Palatal injection, Indirect palatal injection
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 5 Jan 2023 (actual)
- Primary completion
- 20 May 2023 (estimated)
- Study completion
- 20 May 2023 (estimated)
- First posted
- 12 May 2023 (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 anesthesia injections are sometimes painful, resulting in antagonistic cooperation, fear, and anxiety in children. This study aims to investigate the effectiveness of vibratory and cold stimulation before the injection to reduce pain. Purpose of the study: Evaluate the effectiveness of Buzzy® in pain reduction during local anesthesia administration compared to the traditional topical anesthetic gel in pediatric patients.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
- Model description
- The Participants will be randomly and equally allocated into 2 groups with 2 subgroups each
| Arm | Type | Receives |
|---|---|---|
| Direct local anesthesia with Buzzy | Experimental | Other: Buccal and direct palatal injection with the aid of Buzzy |
| Indirect local anesthesia with Buzzy | Experimental | Other: Buccal and indirect palatal injection with the aid of Buzzy |
| Direct local anesthesia | Active comparator | Other: Buccal and direct palatal injection without Buzzy |
| Indirect local anesthesia | Active comparator | Other: Buccal and indirect palatal injection without Buzzy |
Who may qualify
- Ages
- 5 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Patients who are in need of extraction of maxillary posterior teeth.
- Children free of any systemic disease or special health care needs (ASA I).
- Children with no learning disabilities.
- Positive or definitely positive behavior during preoperative assessments according to the Frankl Scale.
- Patients whose parents will give consent to participate.
Key exclusion criteria (5 listed)
- Having active sites of pathosis in the area of injection that could affect the anesthetic assessment.
- Signs of reversible pulpitis.
- Restorable tooth.
- Patients allergic to local anesthesia or having a family history of allergy to local anesthesia.
- Patients with acute oral or facial infection (swelling and/or cellulites )
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 |
|---|---|---|
| Buccal and direct palatal injection with the aid of BuzzyChildren are assigned to local anesthesia after using the Buzzy vibration unit extraorally for 2 minutes using buccal and direct palatal injection | Other | Direct local anesthesia with Buzzy |
| Buccal and indirect palatal injection with the aid of BuzzyChildren are assigned to local anesthesia after using the Buzzy vibration unit extraorally for 2 minutes using buccal and indirect palatal injection | Other | Indirect local anesthesia with Buzzy |
| Buccal and direct palatal injection without BuzzyChildren are assigned to local anesthesia after using topical analgesic gel (benzocaine 20%) intraorally for 1 minute using buccal and direct palatal injection | Other | Direct local anesthesia |
| Buccal and indirect palatal injection without BuzzyChildren are assigned to local anesthesia after using topical analgesic gel (benzocaine 20%) intraorally for 1 minute using buccal and indirect palatal injection | Other | Indirect local anesthesia |
Primary outcome
Change in pain scores
Time frame: Baseline and up to 1 hour
Visual Analogue Scale is used and it ranges from 0 to 10. the ''0'' point indicates ''no pain'' and ''10'' point indicates the worst possible pain.
Change in child's behavior
Time frame: During the procedure
Sound, eye,motor (SEM) scale is used. it assess child's pain perception by observing discomfot levels on SEM during injections. Total scores for SEM range from 0 to 9 based on 0-3 score for each parameter. Score 0: Comfort Score 1: Mild disocomfort Score 2: Moderate discomfort Score 3: Severe discomfort
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2023.
- Derived from this study: PubMed 40462040Hambouta HM, Sharaf DA, Wahba NA. Effectiveness of cold vibratory stimuli on pain perception governing infiltration anesthesia in the maxillary arch in children: a randomized controlled clinical trial. BMC Oral Health. 2025 Jun 3;25(1):900. doi: 10.1186/s12903-025-06170-4.
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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.
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 Buccal and direct palatal injection with the aid of Buzzy, Buccal and indirect palatal injection with the aid of Buzzy and Buccal and direct palatal injection without Buzzy in people with Anesthesia, Local, run by Alexandria 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 5 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: status not confirmed, as of the sponsor's last update on 12 May 2023. 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?
Results are not available in the source record.
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?
Change in pain scores (time frame: Baseline and up to 1 hour). The study lists 2 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 NCT05857033, 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 12 May 2023.