Dental AnxietyNCT07045116
Electronic vs. Conventional Syringes: Impact on Pediatric Pain and Anxiety
A study testing Electronic anesthesia and Conventional anesthesia in people with Dental Anxiety and Pain Management, run by Randa Omer Ahmed Bashir at 1 site in Egypt.
Trial summary
Study Overview Purpose: To compare pain and anxiety levels in children aged 6-8 during local anesthesia administration using electronic vs. conventional syringes. Design: Split-mouth randomized controlled trial (RCT) involving 40 children receiving both types of anesthesia during pulp therapy of bilateral maxillary… Read more about this study
- Who is it for?
- Ages 6 to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Anxiety, Pain Management
- What is being tested?
- Electronic anesthesia and Conventional anesthesia
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2024to 30 Aug 2025
- 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 8 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 6-8-year-old children.
- Medically free (ASA class I).
- Children attending their first dental visit.
- The patient should have at least one vital primary molar with deep carious lesion on each side.
Who cannot join
- Patient has any allergy to local anesthesia.
- Patients take any medications that affect the salivary flow.
- Patient taken corticosteroid.
- Children whose parents or legal guardians refuse to sign the informed consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Dentistry, Ain Shams university
Cairo
About this study
Official title: Effectiveness of Electronic Anesthesia Delivery Syringe Versus Conventional Syringe on Pain and Anxiety Perception During Local Anesthetic Injection in Children Randomized Clinical Trial
Study Overview Purpose: To compare pain and anxiety levels in children aged 6-8 during local anesthesia administration using electronic vs. conventional syringes.
Design: Split-mouth randomized controlled trial (RCT) involving 40 children receiving both types of anesthesia during pulp therapy of bilateral maxillary primary molars.
Read more
Objectives Primary Outcome: Pain level measured via Visual Analogue Scale (VAS).
Secondary Outcomes:
Physiological markers: heart rate and oxygen saturation via pulse oximetry.
Salivary amylase levels (anxiety biomarker) assessed using ELISA.
Methodology Children are randomly assigned to receive electronic anesthesia on one side and conventional on the other in two separate visits.
Saliva samples are collected before and after each injection.
Double-blind setup: children blinded using sunglasses; statistician also blinded.
Same operator administers all injections for consistency.
Ethical Considerations Written informed consent and assent obtained.
Risks (e.g., systemic toxicity, allergic reactions) minimized via dosage limits and patient monitoring.
Privacy and data security measures in place.
Statistical Analysis Data analyzed using SPSS; significance set at p ≤ 0.05.
Sample size calculated for adequate power (n = 33 minimum; 40 enrolled).
Funding Self-funded.
Clinical Relevance Electronic anesthesia may offer a less painful and anxiety-inducing alternative for pediatric dental patients, potentially improving children's long-term attitude toward dental care.
Read the detailed description
- Title and Context Title: Effectiveness of Electronic Anesthesia Delivery Syringe Versus Conventional Syringe on Pain and Anxiety Perception During Local Anesthetic Injection in Children. Submitted by: Randa Omer Ahmed Bashir, for partial fulfillment of a master's degree in Pediatric Dentistry at Ain Shams University. Supervisors: Assoc. Prof. Dr. Reham Khaled Elghazawy and Dr. Nour Abdelmonem Wahba.
- Abstract Problem Statement: Local anesthesia causes pain and anxiety, especially in children. Objective: To compare electronic vs. conventional anesthesia during pulp therapy in 6-8-year-old children. Design: Split-mouth RCT involving 40 children. Outcomes: Primary: Pain measured by Visual Analogue Scale (VAS). Secondary: Heart rate, oxygen saturation, and salivary amylase (stress biomarker) using ELISA.
- Background Local anesthesia is a primary source of fear in children due to needle insertion, pressure, and speed of delivery. Minimizing pain and anxiety is critical for long-term positive dental attitudes. Electronic anesthesia devices may reduce these discomforts through: Controlled delivery rate. Reduced injection pressure. Numbing tissue ahead of the needle.
- Research Question (PICOTS Framework) Population: 40 children (6-8 years old). Intervention: Electronic anesthesia. Comparator: Conventional anesthesia. Outcome: Pain (VAS), heart rate, oxygen saturation, salivary amylase. Time: Two visits. Setting: Ain Shams University Pediatric Dentistry outpatient clinic (Jan 2024-Jan 2025).
- Aim and Objectives Aim: To assess pain and anxiety levels during local anesthesia using electronic vs. conventional syringes. Primary Outcome: Pain via VAS before and after anesthesia. Secondary Outcomes: Heart rate and oxygen saturation using pulse oximetry. Salivary amylase levels via ELISA test.
- Hypothesis Null Hypothesis (H0): No difference between electronic and conventional anesthesia in reducing pain and anxiety.
- Ethical Considerations Risks: Pain, discomfort, self-injury post-procedure, potential allergic reactions. Risk Minimization: Proper selection and dosage of anesthetic agents. Use of topical anesthetic pre-injection. Postoperative instructions to avoid tissue trauma. Privacy \& Confidentiality: Anonymized data using patient codes. Informed Consent: Written consent and assent obtained. Adverse Events: Monitored and reported with defined procedures. Sample Disposal: Discarded as biohazardous waste after study completion.
- Study Design Type: Randomized Controlled Trial (RCT). Design: Split-mouth, double-blinded. Blinding: Patients blinded with sunglasses. Statistician and assessors blinded to allocation. Randomization Tool: Sealed Envelope computer-generated randomization. Allocation Concealment: Handled by a third party.
- Materials and Methods Study Population Inclusion Criteria: 6-8 years old. Medically free (ASA I). First dental visit. At least one vital deep carious molar on each side of maxilla. Exclusion Criteria: Allergy to local anesthetic. Use of corticosteroids or drugs affecting saliva. Declined consent. Sample Size: Required Sample: 33 children (based on power analysis). Final Enrolled: 40 children. Intervention Procedures: Visit 1: One side receives either conventional or electronic anesthesia according to randomization. (Fact: the right side always received electronic anesthesia, while the left side received conventional anesthesia). Visit 2: Opposite side receives the other type of anesthesia. Procedure: Topical anesthetic applied 1-2 minutes. Injection using 4% articaine with 1:100,000 adrenaline. VAS recorded post-injection. Heart rate and oxygen saturation measured pre- and post-injection using pulse oximeter. Saliva samples collected: Pre-injection (baseline). Post-injection (after each type). Saliva stored frozen and tested with ELISA.
- Bias Minimization Strategies Selection Bias: Controlled through randomization and allocation concealment. Performance Bias: Double-blind design. Detection Bias: Blinded outcome assessors. Attrition Bias: Risk due to single follow-up, acknowledged in design. Reporting Bias: All outcomes will be reported.
- Statistical Analysis Software: IBM® SPSS® Statistics Version 26. Tests: Categorical data: Chi-square test. Numerical data: Normal distribution: Mean ± SD, Paired t-test. Non-normal distribution: Median and range, Wilcoxon signed-rank test. Significance Level: p ≤ 0.05.
- Funding Source: Self-funded.
- Clinical Relevance Electronic anesthesia offers less pain, better anxiety control, and may become a preferred technique in pediatric dentistry, especially for first-time dental patients.
- Conditions
- Dental Anxiety, Pain Management
- Being tested
- Electronic anesthesia, Conventional anesthesia
- Keywords
- dental anxiety, salivary amylase, dental syringes, electronic anesthesia
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electronic anesthesiaDevice
Also called pen injector
The child will receive electronic anesthesia to the right side of the upper jaw; the pain and anxiety level will be assessed.
Conventional anesthesiaDevice
Also called Conventional syringe
The child will receive conventional anesthesia to the maxillary left side
| Study group | Role | What they receive |
|---|---|---|
| Maxillary right primary molar | Active comparator | Maxillary right primary molar will receive electronic anesthesia Receives: Device: Electronic anesthesia |
| Maxillary left primary molar | Active comparator | Maxillary left primary molar will receive conventional anesthesia Receives: Device: Conventional anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Perception
Tool: Visual Analogue Scale (VAS)
Scale: 0 (no pain) to 10 (worst possible pain)
Purpose: To quantitatively assess the child's subjective pain level post-injection.
Measured: Timing: Immediately after the administration of local anesthesia (both electronic and conventional)
Secondary outcomes (3)
Heart Rate (HR)
Using Finger-type Pulse Oximeter
Measured: Immediately before and after the administration of local anesthesia (both electronic and conventional)
Oxygen Saturation
Using Finger-type Pulse Oximeter
Measured: Immediately before and after both the Electronic and Conventional anesthesia
Salivary amylase level
Using ELIZA kit (Enzyme-Linked Immunosorbent Assay)
Measured: Before any injection (baseline) - After conventional anesthesia (The saliva samples must be collected up to 30 minutes after the injection) - After electronic anesthesia (The saliva samples must be collected up to 30 minutes after the injection)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2025
- Study start1 Dec 2024
- Primary completion31 Jul 2025 (estimated)
- Study completion30 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental AnxietyStudies 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
- Model description
- In our dental study, the investigator will utilize a computerized system called "Sealed Envelope" to implement a random assignment of the treatment options of the participants' teeth. This randomization process is crucial to ensure that each participant receives either conventional or electronic anesthesia during their first dental treatment. While, during their second dental treatment the alternative method of anesthesia will be used. The trial is specifically constructed such that for each participant, electronic anesthetic will be applied to teeth on the right side, whereas conventional anesthesia will be used on the left side. To uphold the principles' allocation concealment, which is essential for maintaining the study's integrity. It will be kept with a third party, who will not be involved in the data collection. The allocation assignment of the participants will be requested each time a new participant is recruited in the trial.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Randa Omer Ahmed Bashir
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Randa Omer Ahmed Bashir, Ain Shams University
- Investigators
- Reham Khaled Elghazawy, Associate professor, Study director, Faculty of Dentistry, Ain Shams universityNour Wahba, Lecturer/ Pedodontist, Study director, Faculty of Dentistry, Ain Shams university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07045116
- Sponsor's protocol ID
- FDASU-Rec IM012410
- Status last verified
- Dec 2024
- First submitted
- 28 May 2025
- Last updated
- 31 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The Ethical committee refuse to share the patient information because of confidentiality
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Electronic Anesthesia Delivery Syringe Versus Conventional Syringe on Pain and Anxiety Perception During Local Anesthetic Injection in Children Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07045116
- Acronym / sponsor ID
- FDASU-Rec IM012410
- Conditions
- Dental Anxiety, Pain Management
- Keywords
- dental anxiety, salivary amylase, dental syringes, electronic anesthesia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Randa Omer Ahmed BashirUniversity, hospital or other
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 31 Jul 2025 (estimated)
- Study completion
- 30 Aug 2025 (estimated)
- First posted
- 1 Jul 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.
Study Overview Purpose: To compare pain and anxiety levels in children aged 6-8 during local anesthesia administration using electronic vs. conventional syringes.
Design: Split-mouth randomized controlled trial (RCT) involving 40 children receiving both types of anesthesia during pulp therapy of bilateral maxillary primary molars.
Objectives Primary Outcome: Pain level measured via Visual Analogue Scale (VAS).
Secondary Outcomes:
Physiological markers: heart rate and oxygen saturation via pulse oximetry.
Salivary amylase levels (anxiety biomarker) assessed using ELISA.
Methodology Children are randomly assigned to receive electronic anesthesia on one side and conventional on the other in two separate visits.
Saliva samples are collected before and after each injection.
Double-blind setup: children blinded using sunglasses; statistician also blinded.
Same operator administers all injections for consistency.
Ethical Considerations Written informed consent and assent obtained.
Risks (e.g., systemic toxicity, allergic reactions) minimized via dosage limits and patient monitoring.
Privacy and data security measures in place.
Statistical Analysis Data analyzed using SPSS; significance set at p ≤ 0.05.
Sample size calculated for adequate power (n = 33 minimum; 40 enrolled).
Funding Self-funded.
Clinical Relevance Electronic anesthesia may offer a less painful and anxiety-inducing alternative for pediatric dental patients, potentially improving children's long-term attitude toward dental care.
Detailed description
- Title and Context Title: Effectiveness of Electronic Anesthesia Delivery Syringe Versus Conventional Syringe on Pain and Anxiety Perception During Local Anesthetic Injection in Children. Submitted by: Randa Omer Ahmed Bashir, for partial fulfillment of a master's degree in Pediatric Dentistry at Ain Shams University. Supervisors: Assoc. Prof. Dr. Reham Khaled Elghazawy and Dr. Nour Abdelmonem Wahba.
- Abstract Problem Statement: Local anesthesia causes pain and anxiety, especially in children. Objective: To compare electronic vs. conventional anesthesia during pulp therapy in 6-8-year-old children. Design: Split-mouth RCT involving 40 children. Outcomes: Primary: Pain measured by Visual Analogue Scale (VAS). Secondary: Heart rate, oxygen saturation, and salivary amylase (stress biomarker) using ELISA.
- Background Local anesthesia is a primary source of fear in children due to needle insertion, pressure, and speed of delivery. Minimizing pain and anxiety is critical for long-term positive dental attitudes. Electronic anesthesia devices may reduce these discomforts through: Controlled delivery rate. Reduced injection pressure. Numbing tissue ahead of the needle.
- Research Question (PICOTS Framework) Population: 40 children (6-8 years old). Intervention: Electronic anesthesia. Comparator: Conventional anesthesia. Outcome: Pain (VAS), heart rate, oxygen saturation, salivary amylase. Time: Two visits. Setting: Ain Shams University Pediatric Dentistry outpatient clinic (Jan 2024-Jan 2025).
- Aim and Objectives Aim: To assess pain and anxiety levels during local anesthesia using electronic vs. conventional syringes. Primary Outcome: Pain via VAS before and after anesthesia. Secondary Outcomes: Heart rate and oxygen saturation using pulse oximetry. Salivary amylase levels via ELISA test.
- Hypothesis Null Hypothesis (H0): No difference between electronic and conventional anesthesia in reducing pain and anxiety.
- Ethical Considerations Risks: Pain, discomfort, self-injury post-procedure, potential allergic reactions. Risk Minimization: Proper selection and dosage of anesthetic agents. Use of topical anesthetic pre-injection. Postoperative instructions to avoid tissue trauma. Privacy \& Confidentiality: Anonymized data using patient codes. Informed Consent: Written consent and assent obtained. Adverse Events: Monitored and reported with defined procedures. Sample Disposal: Discarded as biohazardous waste after study completion.
- Study Design Type: Randomized Controlled Trial (RCT). Design: Split-mouth, double-blinded. Blinding: Patients blinded with sunglasses. Statistician and assessors blinded to allocation. Randomization Tool: Sealed Envelope computer-generated randomization. Allocation Concealment: Handled by a third party.
- Materials and Methods Study Population Inclusion Criteria: 6-8 years old. Medically free (ASA I). First dental visit. At least one vital deep carious molar on each side of maxilla. Exclusion Criteria: Allergy to local anesthetic. Use of corticosteroids or drugs affecting saliva. Declined consent. Sample Size: Required Sample: 33 children (based on power analysis). Final Enrolled: 40 children. Intervention Procedures: Visit 1: One side receives either conventional or electronic anesthesia according to randomization. (Fact: the right side always received electronic anesthesia, while the left side received conventional anesthesia). Visit 2: Opposite side receives the other type of anesthesia. Procedure: Topical anesthetic applied 1-2 minutes. Injection using 4% articaine with 1:100,000 adrenaline. VAS recorded post-injection. Heart rate and oxygen saturation measured pre- and post-injection using pulse oximeter. Saliva samples collected: Pre-injection (baseline). Post-injection (after each type). Saliva stored frozen and tested with ELISA.
- Bias Minimization Strategies Selection Bias: Controlled through randomization and allocation concealment. Performance Bias: Double-blind design. Detection Bias: Blinded outcome assessors. Attrition Bias: Risk due to single follow-up, acknowledged in design. Reporting Bias: All outcomes will be reported.
- Statistical Analysis Software: IBM® SPSS® Statistics Version 26. Tests: Categorical data: Chi-square test. Numerical data: Normal distribution: Mean ± SD, Paired t-test. Non-normal distribution: Median and range, Wilcoxon signed-rank test. Significance Level: p ≤ 0.05.
- Funding Source: Self-funded.
- Clinical Relevance Electronic anesthesia offers less pain, better anxiety control, and may become a preferred technique in pediatric dentistry, especially for first-time dental patients.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- In our dental study, the investigator will utilize a computerized system called "Sealed Envelope" to implement a random assignment of the treatment options of the participants' teeth. This randomization process is crucial to ensure that each participant receives either conventional or electronic anesthesia during their first dental treatment. While, during their second dental treatment the alternative method of anesthesia will be used. The trial is specifically constructed such that for each participant, electronic anesthetic will be applied to teeth on the right side, whereas conventional anesthesia will be used on the left side. To uphold the principles' allocation concealment, which is essential for maintaining the study's integrity. It will be kept with a third party, who will not be involved in the data collection. The allocation assignment of the participants will be requested each time a new participant is recruited in the trial.
| Arm | Type | Receives |
|---|---|---|
| Maxillary right primary molar | Active comparator | Device: Electronic anesthesiaMaxillary right primary molar will receive electronic anesthesia |
| Maxillary left primary molar | Active comparator | Device: Conventional anesthesiaMaxillary left primary molar will receive conventional anesthesia |
Who may qualify
- Ages
- 6 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 6-8-year-old children.
- Medically free (ASA class I).
- Children attending their first dental visit.
- The patient should have at least one vital primary molar with deep carious lesion on each side.
Key exclusion criteria (4 listed)
- Patient has any allergy to local anesthesia.
- Patients take any medications that affect the salivary flow.
- Patient taken corticosteroid.
- Children whose parents or legal guardians refuse to sign the informed consent.
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 |
|---|---|---|
| Electronic anesthesiaAlso: pen injectorThe child will receive electronic anesthesia to the right side of the upper jaw; the pain and anxiety level will be assessed. | Device | Maxillary right primary molar |
| Conventional anesthesiaAlso: Conventional syringeThe child will receive conventional anesthesia to the maxillary left side | Device | Maxillary left primary molar |
Primary outcome
Pain Perception
Time frame: Timing: Immediately after the administration of local anesthesia (both electronic and conventional)
Tool: Visual Analogue Scale (VAS) Scale: 0 (no pain) to 10 (worst possible pain) Purpose: To quantitatively assess the child's subjective pain level post-injection.
3 secondary outcomes
Heart Rate (HR)
Time frame: Immediately before and after the administration of local anesthesia (both electronic and conventional)
Oxygen Saturation
Time frame: Immediately before and after both the Electronic and Conventional anesthesia
Salivary amylase level
Time frame: Before any injection (baseline) - After conventional anesthesia (The saliva samples must be collected up to 30 minutes after the injection) - After electronic anesthesia (The saliva samples must be collected up to 30 minutes after the injection)
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 31 Jul 2025.
- Individual participant dataSharing planned: No. The Ethical committee refuse to share the patient information because of confidentiality
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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.
Reham Khaled Elghazawy, Associate professor study director
Faculty of Dentistry, Ain Shams university
Nour Wahba, Lecturer/ Pedodontist study director
Faculty of Dentistry, Ain Shams 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 Electronic anesthesia and Conventional anesthesia in people with Dental Anxiety and Pain Management, run by Randa Omer Ahmed Bashir 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 4 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: looking for participants now, as of the sponsor's last update on 31 Jul 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?
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 Randa Omer, Master's degree candidate (+201156298126, randaomar@dent.asu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Perception (time frame: Timing: Immediately after the administration of local anesthesia (both electronic and conventional)). 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 31 Jul 2025.