Anesthesia, LocalNCT06242743
Type of Needle Bevel on Pain Perception in Children During Inferior Alveolar Nerve Block Anesthesia
A study testing Scalpel blade needles and standard blade needles in people with Anesthesia, Local, run by Hams Hamed Abdelrahman at 1 site in Egypt.
Trial summary
fear of the discomfort that comes with anesthetic needle insertion. For dental local anesthesia, needles with a scalpel-designed bevel have been claimed to decrease pain elicited by injection. Read more about this study
- Who is it for?
- Ages 5 to 7 years
- Conditions the study is for
- Anesthesia, Local
- What is being tested?
- Scalpel blade needles and standard blade needles
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2024to 27 Mar 2024
- 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 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Healthy children with ASA I, II Classification.
- Children with no learning disabilities.
- Positive or definitely positive behavior according to the Frankl Scale.
- Patient requiring local anesthetic injection IANB for dental treatment.
- Written consent of the legal guardian.
Who cannot join
- Medically compromised patient.
- Children with emergency treatment needs, such as abscess, cellulitis and space infection.
- Hypersensitivity to local anesthetic drugs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Needle Bevel Type on Pain Perception in Children During Inferior Alveolar Nerve Block Anesthesia (a Randomized Controlled Clinical Trial)
fear of the discomfort that comes with anesthetic needle insertion. For dental local anesthesia, needles with a scalpel-designed bevel have been claimed to decrease pain elicited by injection.
Objective of the study: The purpose of this study is to assess the effect of needle bevel on patient's perception of pain during inferior alveolar nerve block anesthesia and the needle tip will be further assessed for deformation.
Materials and Methods: The study will be a double-blind randomized controlled clinical trial, with a parallel design. A total of sixty-six healthy children will be selected from The Pediatric Dentistry and Dental Public Health Clinic, Faculty of Dentistry, Alexandria University, Egypt. Children will be selected with scores 3 or 4 Frankel behavioral rating scale. Written consent will be obtained from the legal guardian. Participants will be randomly allocated into two groups according to the type of needle bevel that will be used. Group I (test group) will receive inferior alveolar nerve block (IANB) using a double scalpel blade bevel needle, while group II (control group) will receive IANB using a standard blade bevel needle. All the procedures will be videotaped. Pain reaction will be evaluated subjectively using a face scale modified from the Maunuksela scale and objectively using the Sensory, Eye, and Motor (SEM) scale. After the respective single injection, the needles will be fixed on an object slide and prepared for microscopic examination.
- Conditions
- Anesthesia, Local
- Being tested
- Scalpel blade needles, standard blade needles
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Scalpel blade needlesOther
Patients were assigned to IANB injection by double scalpel blade bevel needles.
standard blade needlesOther
Patients were assigned to IANB injection by standard blade bevel needles.
| Study group | Role | What they receive |
|---|---|---|
| Test group | Experimental | Not described Receives: Other: Scalpel blade needles |
| Control group | Active comparator | Not described Receives: Other: standard blade needles |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Pain assessment
Sound, Eye, and Motor scales will be used for pain assessment by viewing the recorded videotapes for the patients during the dental procedure.
it assesses changes in comfort level as follows;
- Comfort
- Mild discomfort
- Moderate discomfort
- Severe discomfort higher scores mean higher discomfort Minimum score: 1 Maximum score: 12
Measured: During procedure
Subjective pain assessment
Each patient will be trained on using the scale by modeling and then requesting every patient to think of the last time she/he went through a painful experience and to choose the facial expression that best relates his/her current experience of discomfort to the previous one.
Facial scales' categories are as follows Score A: Satisfied Score B Indifference Score C: Dissatisfaction
Measured: During procedure
Secondary outcomes (1)
Needle deformation
Needles will be evaluated under stereoscopic microscope to measure the amount of deformation or deviation in micorn meter from the original unused ones.
Measured: During procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2024
- Study start1 Jan 2024
- Primary completion27 Mar 2024
- Study completion27 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anesthesia, LocalStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hams Hamed Abdelrahman
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hams Hamed Abdelrahman, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06242743
- Sponsor's protocol ID
- 0726_07/2023
- Status last verified
- May 2025
- First submitted
- 1 Jan 2024
- Last updated
- 29 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Needle Bevel Type on Pain Perception in Children During Inferior Alveolar Nerve Block Anesthesia (a Randomized Controlled Clinical Trial)
- ClinicalTrials.gov ID
- NCT06242743
- Acronym / sponsor ID
- 0726_07/2023
- Conditions
- Anesthesia, Local
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Hams Hamed AbdelrahmanUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 27 Mar 2024 (actual)
- Study completion
- 27 Mar 2024 (actual)
- First posted
- 5 Feb 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.
fear of the discomfort that comes with anesthetic needle insertion. For dental local anesthesia, needles with a scalpel-designed bevel have been claimed to decrease pain elicited by injection.
Objective of the study: The purpose of this study is to assess the effect of needle bevel on patient's perception of pain during inferior alveolar nerve block anesthesia and the needle tip will be further assessed for deformation.
Materials and Methods: The study will be a double-blind randomized controlled clinical trial, with a parallel design. A total of sixty-six healthy children will be selected from The Pediatric Dentistry and Dental Public Health Clinic, Faculty of Dentistry, Alexandria University, Egypt. Children will be selected with scores 3 or 4 Frankel behavioral rating scale. Written consent will be obtained from the legal guardian. Participants will be randomly allocated into two groups according to the type of needle bevel that will be used. Group I (test group) will receive inferior alveolar nerve block (IANB) using a double scalpel blade bevel needle, while group II (control group) will receive IANB using a standard blade bevel needle. All the procedures will be videotaped. Pain reaction will be evaluated subjectively using a face scale modified from the Maunuksela scale and objectively using the Sensory, Eye, and Motor (SEM) scale. After the respective single injection, the needles will be fixed on an object slide and prepared for microscopic examination.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test group | Experimental | Other: Scalpel blade needles |
| Control group | Active comparator | Other: standard blade needles |
Who may qualify
- Ages
- 5 to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Healthy children with ASA I, II Classification.
- Children with no learning disabilities.
- Positive or definitely positive behavior according to the Frankl Scale.
- Patient requiring local anesthetic injection IANB for dental treatment.
- Written consent of the legal guardian.
Key exclusion criteria (3 listed)
- Medically compromised patient.
- Children with emergency treatment needs, such as abscess, cellulitis and space infection.
- Hypersensitivity to local anesthetic drugs
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 |
|---|---|---|
| Scalpel blade needlesPatients were assigned to IANB injection by double scalpel blade bevel needles. | Other | Test group |
| standard blade needlesPatients were assigned to IANB injection by standard blade bevel needles. | Other | Control group |
Primary outcome
Objective Pain assessment
Time frame: During procedure
Sound, Eye, and Motor scales will be used for pain assessment by viewing the recorded videotapes for the patients during the dental procedure. it assesses changes in comfort level as follows; 1. Comfort 2. Mild discomfort 3. Moderate discomfort 4. Severe discomfort higher scores mean higher discomfort Minimum score: 1 Maximum score: 12
Subjective pain assessment
Time frame: During procedure
Each patient will be trained on using the scale by modeling and then requesting every patient to think of the last time she/he went through a painful experience and to choose the facial expression that best relates his/her current experience of discomfort to the previous one. Facial scales' categories are as follows Score A: Satisfied Score B Indifference Score C: Dissatisfaction
1 secondary outcome
Needle deformation
Time frame: During procedure
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 29 May 2025.
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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 Scalpel blade needles and standard blade needles in people with Anesthesia, Local, run by Hams Hamed Abdelrahman 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 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: finished, as of the sponsor's last update on 29 May 2025. 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?
Objective Pain assessment (time frame: During procedure). 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?
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 29 May 2025.