Dental CariesNCT07101068
Assessment of Pain and Anxiety During Infiltration Anesthesia Using Dental Anesthesia Injector Versus Conventional Syringe in Pediatric Patients
A study testing Dental Anesthesia Injector and conventional syringe in people with Dental Caries and Reversible Pulpitis, run by Ain Shams University at 2 sites in Egypt.
Trial summary
This randomized controlled trial is conducted on pediatric dental patients to compare the effectiveness of local anesthesia administered using a dental anesthesia injector device versus the traditional syringe method. Read more about this study
- Who is it for?
- Ages 6 to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries, Reversible Pulpitis
- What is being tested?
- Dental Anesthesia Injector and conventional syringe
- 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
- 2 sitesEgypt
- Study dates
- 25 Jan 2024to 1 Oct 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
- normal healthy patients (ASA I)
- Undergoing the first dental local anesthesia experience
- Presence of one at least vital deeply carious maxillary primary molar indicated for pulpotomy on each side of maxilla
- Score 3 or 4 of Frankl scale of child behavior
Who cannot join
- Presence of gingivitis, dental abscess, facial trauma/ injury
- Administration of analgesic 48 h before randomization
- Presence of allergy from local anesthesia
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt2 sites, 2 recruiting
- Recruiting
Ain Shams University
Cairo, Cairo Governorate
Postgraduate Studies, Ain Shams University, 0222639083 ext. 20102300497, Dean@dent.asu.edu.org
Samaa Abdo Mahmoud, Demonstrator, 201023004597, samaa.abdo@dent.bsu.edu.eg
- Recruiting
Faculty of dentistry, Ain Shams University
Cairo, Cairo Governorate
About this study
Official title: A Randomized Clinical Trial to Assess Pain and Anxiety During Infiltration Anesthesia Using Dental Anesthesia Injector Versus Conventional Syringe in Pediatric Patients
This randomized controlled trial is conducted on pediatric dental patients to compare the effectiveness of local anesthesia administered using a dental anesthesia injector device versus the traditional syringe method. The study aims to assess and compare pain and anxiety levels associated with both methods, using both subjective (self-reported) and objective measures. The goal is to identify an alternative technique that minimizes pain and anxiety in pediatric dental patients.
Read the detailed description
This randomized controlled split-mouth clinical trial aims to assess pain and anxiety in pediatric dental patients during and immediately after the administration of local anesthesia using a dental anesthesia injector device compared to a conventional syringe.
The study will include healthy, cooperative children aged 6 to 8 years, each having at least one vital deeply carious maxillary primary molar with signs and symptoms of reversible pulpitis on each side of the maxilla requiring buccal infiltration anesthesia prior to pulpotomy.
Each child will receive both injection techniques on separate occasions, with random assignment of the injection method to either the right or left side (split-mouth design).
To evaluate pain and anxiety, the following tools will be used:
Pain: Visual Analogue Scale (VAS) Anxiety: Corah Dental Anxiety Scale Physiological measures: Heart rate and oxygen saturation levels, recorded using a pulse oximeter Data will be collected during and immediately after the injection. The aim is to determine whether the dental anesthesia injector provides a less painful and less anxiety-inducing experience compared to the traditional syringe method.
- Conditions
- Dental Caries, Reversible Pulpitis
- Being tested
- Dental Anesthesia Injector, conventional syringe
- Keywords
- Pediatric Dentistry, Local Anesthesia, Dental Anesthesia Injector, Conventional Syringe, Pain Assessment, Vasual Analogue Scale, Corah Dental Anxiety Scale, Pulse Oximeter, Split-mouth Design, Reversible Pulpitis
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dental Anesthesia InjectorDevice
Topical anesthesia lidocain for 1 minute will be applied on previously dried mucosa. Local anesthesia administration( artican 4% +1/100,000 With extra short needles 30G-10mm ) using Dental Anesthesia Injector.
conventional syringeOther
Topical anesthesia lidocain for 1 minute will be applied on previously dried mucosa. Local anesthesia administration( artican 4% +1/100,000 With extra short needles 30G-10mm ) using conventional syringe
| Study group | Role | What they receive |
|---|---|---|
| Dental Anesthesia Injector | Experimental | Topical anesthesia lidocain for 1 minute will be applied on previously dried mucosa.
Local anesthesia administration( artican 4% +1/100,000 With extra short needles 30G-10mm ) using Dental Anesthesia injector . Receives: Device: Dental Anesthesia Injector |
| Conventional syringe | Active comparator | Topical anesthesia lidocain for 1 minute will be applied on previously dried mucosa. Local anesthesia administration( artican 4% +1/100,000 With extra short needles 30G-10mm ) using conventional syringe Receives: Other: conventional syringe |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain during injection
The pain felt by patient will be assessed by Visual analogue scale which is a subjective scale {rating from 0 (no pain) to 10 (worst pain ) }
Pulse rate and oxygen saturation will be assessed also which are objective tools where the normal pulse rate is from 60 to 100 beats per minute, more than normal heart rate for the patient during injection and 1 minute after means anxiety The normal Oxygen saturation of the body is from 95% up to 100% the increase in the rating of the Oxygen saturation during the injection and 1 minute after injection means that the patient feels anxiety
Measured: The pain felt by patient will be assessed by Visual analogue scale, Pulse rate and Oxygen saturation at day 1 of anesthesia injection.
Anxiety felt by the patient
Anxiety felt by the patient during dental visit will be assessed using Corah Dental Anxiety Scale which is a subjective scale consist of brief questionnaire designed to measure anxiety related to dental visits, each question has 5 answers from a to e (a) answers give rating 1 that mean least anxiety felt and (e) answers give rating 5 that mean sever anxiety. If the total rating of the 4 questions <9 means that the patient has mild anxiety. If the total rating from 15 to 20 means that the patient has sever anxiety.
Measured: the scale will be used at day 1 of anesthesia injection
Secondary outcomes (1)
Need for additional anesthesia
Need for additional anesthesia will be assessed by the operator if the patient feels pain and we have to administer additional anesthesia with the same concentration and the same tool of injection for the second time to treat the same tooth at same dental visit.
Measured: The assessment will be done during dental visit at day 1 of anesthesia injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2025
- Study start25 Jan 2024
- Primary completion1 Oct 2025 (estimated)
- Study completion1 Oct 2025 (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 Dental CariesStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- Crossover
- Model description
- This randomized, split-mouth clinical trial uses a computerized randomization system (Sealed Envelope) to allocate the two interventions: conventional anesthesia and Dental Anesthesia Injector. For each participant, one side of the mouth will receive local anesthesia via the Dental Anesthesia Injector, while the other side will receive the conventional anesthesia method. The randomization process ensures that the assignment of anesthesia methods to the right or left side is random for each participant. Allocation concealment is maintained by a third party who is not involved in data collection and manages the allocation assignments for each new participant
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sarah Mohamed Shafik, Associate Professor, Study director, Pediatric Dentistry department, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07101068
- Sponsor's protocol ID
- FDSU-Rec IMO12441
- Status last verified
- Apr 2025
- First submitted
- 15 Jun 2025
- Last updated
- 3 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Faculty of Dentistry Ain Shams university Research Ethics Committee, state that data will not be shared to preserve the confidentiality.
Publications
Vitale MC, Gallo S, Pascadopoli M, Alcozer R, Ciuffreda C, Scribante A. Local anesthesia with SleeperOne S4 computerized device vs traditional syringe and perceived pain in pediatric patients: a randomized clinical trial. J Clin Pediatr Dent. 2023 Jan;47(1):82-90. doi: 10.22514/jocpd.2023.002. Epub 2023 Jan 3.
PubMed 36627224
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Clinical Trial to Assess Pain and Anxiety During Infiltration Anesthesia Using Dental Anesthesia Injector Versus Conventional Syringe in Pediatric Patients
- ClinicalTrials.gov ID
- NCT07101068
- Acronym / sponsor ID
- FDSU-Rec IMO12441
- Conditions
- Dental Caries, Reversible Pulpitis
- Keywords
- Pediatric Dentistry, Local Anesthesia, Dental Anesthesia Injector, Conventional Syringe, Pain Assessment, Vasual Analogue Scale, Corah Dental Anxiety Scale, Pulse Oximeter
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 25 Jan 2024 (actual)
- Primary completion
- 1 Oct 2025 (estimated)
- Study completion
- 1 Oct 2025 (estimated)
- First posted
- 3 Aug 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.
This randomized controlled trial is conducted on pediatric dental patients to compare the effectiveness of local anesthesia administered using a dental anesthesia injector device versus the traditional syringe method. The study aims to assess and compare pain and anxiety levels associated with both methods, using both subjective (self-reported) and objective measures. The goal is to identify an alternative technique that minimizes pain and anxiety in pediatric dental patients.
Detailed description
This randomized controlled split-mouth clinical trial aims to assess pain and anxiety in pediatric dental patients during and immediately after the administration of local anesthesia using a dental anesthesia injector device compared to a conventional syringe.
The study will include healthy, cooperative children aged 6 to 8 years, each having at least one vital deeply carious maxillary primary molar with signs and symptoms of reversible pulpitis on each side of the maxilla requiring buccal infiltration anesthesia prior to pulpotomy.
Each child will receive both injection techniques on separate occasions, with random assignment of the injection method to either the right or left side (split-mouth design).
To evaluate pain and anxiety, the following tools will be used:
Pain: Visual Analogue Scale (VAS) Anxiety: Corah Dental Anxiety Scale Physiological measures: Heart rate and oxygen saturation levels, recorded using a pulse oximeter Data will be collected during and immediately after the injection. The aim is to determine whether the dental anesthesia injector provides a less painful and less anxiety-inducing experience compared to the traditional syringe method.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This randomized, split-mouth clinical trial uses a computerized randomization system (Sealed Envelope) to allocate the two interventions: conventional anesthesia and Dental Anesthesia Injector. For each participant, one side of the mouth will receive local anesthesia via the Dental Anesthesia Injector, while the other side will receive the conventional anesthesia method. The randomization process ensures that the assignment of anesthesia methods to the right or left side is random for each participant. Allocation concealment is maintained by a third party who is not involved in data collection and manages the allocation assignments for each new participant
| Arm | Type | Receives |
|---|---|---|
| Dental Anesthesia Injector | Experimental | Device: Dental Anesthesia InjectorTopical anesthesia lidocain for 1 minute will be applied on previously dried mucosa. Local anesthesia administration( artican 4% +1/100,000 With extra short needles 30G-10mm ) using Dental Anesthesia injector . |
| Conventional syringe | Active comparator | Other: conventional syringeTopical anesthesia lidocain for 1 minute will be applied on previously dried mucosa. Local anesthesia administration( artican 4% +1/100,000 With extra short needles 30G-10mm ) using conventional syringe |
Who may qualify
- Ages
- 6 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- normal healthy patients (ASA I)
- Undergoing the first dental local anesthesia experience
- Presence of one at least vital deeply carious maxillary primary molar indicated for pulpotomy on each side of maxilla
- Score 3 or 4 of Frankl scale of child behavior
Key exclusion criteria (3 listed)
- Presence of gingivitis, dental abscess, facial trauma/ injury
- Administration of analgesic 48 h before randomization
- Presence of allergy from local 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 |
|---|---|---|
| Dental Anesthesia InjectorTopical anesthesia lidocain for 1 minute will be applied on previously dried mucosa. Local anesthesia administration( artican 4% +1/100,000 With extra short needles 30G-10mm ) using Dental Anesthesia Injector. | Device | Dental Anesthesia Injector |
| conventional syringeTopical anesthesia lidocain for 1 minute will be applied on previously dried mucosa. Local anesthesia administration( artican 4% +1/100,000 With extra short needles 30G-10mm ) using conventional syringe | Other | Conventional syringe |
Primary outcome
Pain during injection
Time frame: The pain felt by patient will be assessed by Visual analogue scale, Pulse rate and Oxygen saturation at day 1 of anesthesia injection.
The pain felt by patient will be assessed by Visual analogue scale which is a subjective scale {rating from 0 (no pain) to 10 (worst pain ) } Pulse rate and oxygen saturation will be assessed also which are objective tools where the normal pulse rate is from 60 to 100 beats per minute, more than normal heart rate for the patient during injection and 1 minute after means anxiety The normal Oxygen saturation of the body is from 95% up to 100% the increase in the rating of the Oxygen saturation during the injection and 1 minute after injection means that the patient feels anxiety
Anxiety felt by the patient
Time frame: the scale will be used at day 1 of anesthesia injection
Anxiety felt by the patient during dental visit will be assessed using Corah Dental Anxiety Scale which is a subjective scale consist of brief questionnaire designed to measure anxiety related to dental visits, each question has 5 answers from a to e (a) answers give rating 1 that mean least anxiety felt and (e) answers give rating 5 that mean sever anxiety. If the total rating of the 4 questions <9 means that the patient has mild anxiety. If the total rating from 15 to 20 means that the patient has sever anxiety.
1 secondary outcome
Need for additional anesthesia
Time frame: The assessment will be done during dental visit at day 1 of anesthesia 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 3 Aug 2025.
- Background: PubMed 36627224Vitale MC, Gallo S, Pascadopoli M, Alcozer R, Ciuffreda C, Scribante A. Local anesthesia with SleeperOne S4 computerized device vs traditional syringe and perceived pain in pediatric patients: a randomized clinical trial. J Clin Pediatr Dent. 2023 Jan;47(1):82-90. doi: 10.22514/jocpd.2023.002. Epub 2023 Jan 3.
- Individual participant dataSharing planned: No. Faculty of Dentistry Ain Shams university Research Ethics Committee, state that data will not be shared to preserve the 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.
Sarah Mohamed Shafik, Associate Professor study director
Pediatric Dentistry department, Ain Shams University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dental Anesthesia Injector and conventional syringe in people with Dental Caries and Reversible Pulpitis, run by Ain Shams University at 2 sites 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 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: looking for participants now, as of the sponsor's last update on 3 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Samaa Abdo Mahmoud, Demonstrator (201023004597, samaa.abdo@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 during injection (time frame: The pain felt by patient will be assessed by Visual analogue scale, Pulse rate and Oxygen saturation at day 1 of anesthesia injection.). 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 NCT07101068, 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 3 Aug 2025.