PainNCT07656194
Local Anesthesia Pen vs Conventional Syringe In The Treatment of Pain and Dental Anxiety
A study testing Dental anesthesia injector in people with Pain and Anxiety, run by Shahad Abudawood at 1 site in Saudi Arabia.
Trial summary
The goal of this is to compare pain and anxiety that may occur during dental anesthesia delivery using conventional dental syringe and the dental anesthesia injector (wireless pain less pen in pediatric dentistry. Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- What is being tested?
- Dental anesthesia injector
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 24 Apr 2024to 1 Jun 2026
- 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 aged between 6-12 years old
- Medically fit
- Requiring dental restorative procedures (Filling).
Who cannot join
- Children younger than 6 years
- Children older than 12 years
- Any significant medical history
- Requiring extensive restorative dental work type such as full crown coverage
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Local Anesthesia Pen vs Conventional Syringe in The Treatment of Pain and Dental Anxiety: A Randomized Controlled Trial
The goal of this is to compare pain and anxiety that may occur during dental anesthesia delivery using conventional dental syringe and the dental anesthesia injector (wireless pain less pen in pediatric dentistry. This is a cross-over randomized clinical trial is to investigate if one technique more efficiant in reducing pain and anaxity. This study could include medically healthy children between the age 6-12 years old requiring restorative dental work. The main question aims to answer [is/are]: Is new painless injector pen better or equal to convintional syrange in reducing both pain and anaxity? Randomization will be generated. Children will recive the first dental treatment under eaither systems then a washout period of 14 days will be carries out, then the same patient will recive the dental treatment on the other side using the 2nd device acording to the manufactuurer instructions.
- Being tested
- Dental anesthesia injector
- Medical subject headings
- Pain, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dental anesthesia injectorProcedure or surgery
Dental anesthesia injector
| Study group | Role | What they receive |
|---|---|---|
| Dental anesthesia injector group | Experimental | The dental anesthesia injector Receives: Procedure: Dental anesthesia injector |
| Conventional Local anaesthesia Syringe | No intervention | Conventional Local anaesthesia Syringe |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Score
Wong-Baker FACES Pain Rating Scale, is a self-report measure consisting of a series of six facial expressions (FACES) representing increasing levels of pain. Scores range from 0 to 10, with 0 (happy face) indicating "no hurt" and 10 ( a crying face) indicating "hurts worst". Higher scores represent greater pain intensity and therefore a worse outcome.
Measured: Baseline and immediate post-procedure
Anxiety using the Modified Dental Anxiety Scale (MDAS)
The Modified Dental Anxiety Scale is a self-reported measure of dental anxiety consisting of five items, each scored on a 5-point Likert scale. Total scores range from 5 to 25, with 5 indicating no dental anxiety and 25 indicating extreme dental anxiety. Higher scores represent greater dental anxiety and therefore a worse outcome.
Measured: Baseline and immediate post- procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2026
- Study start24 Apr 2024
- Primary completion1 Jun 2026
- Study completion1 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shahad Abudawood
- Sponsor type
- University, hospital or other
- Collaborators
- King Abdulaziz University
- Responsible party
- Sponsor-investigator, Shahad Abudawood, King Abdulaziz University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07656194
- Sponsor's protocol ID
- 160-11- 24
- Status last verified
- Jun 2026
- First submitted
- 4 Jun 2026
- Last updated
- 18 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Due to patient privacy
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Local Anesthesia Pen vs Conventional Syringe in The Treatment of Pain and Dental Anxiety: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07656194
- Acronym / sponsor ID
- 160-11- 24
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Shahad AbudawoodUniversity, hospital or other
- Collaborators
- King Abdulaziz University
- Study start
- 24 Apr 2024 (actual)
- Primary completion
- 1 Jun 2026 (actual)
- Study completion
- 1 Jun 2026 (actual)
- First posted
- 18 Jun 2026 (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.
The goal of this is to compare pain and anxiety that may occur during dental anesthesia delivery using conventional dental syringe and the dental anesthesia injector (wireless pain less pen in pediatric dentistry. This is a cross-over randomized clinical trial is to investigate if one technique more efficiant in reducing pain and anaxity. This study could include medically healthy children between the age 6-12 years old requiring restorative dental work. The main question aims to answer [is/are]: Is new painless injector pen better or equal to convintional syrange in reducing both pain and anaxity? Randomization will be generated. Children will recive the first dental treatment under eaither systems then a washout period of 14 days will be carries out, then the same patient will recive the dental treatment on the other side using the 2nd device acording to the manufactuurer instructions.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dental anesthesia injector group | Experimental | Procedure: Dental anesthesia injectorThe dental anesthesia injector |
| Conventional Local anaesthesia Syringe | No intervention | –Conventional Local anaesthesia Syringe |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children aged between 6-12 years old
- Medically fit
- Requiring dental restorative procedures (Filling).
Key exclusion criteria (4 listed)
- Children younger than 6 years
- Children older than 12 years
- Any significant medical history
- Requiring extensive restorative dental work type such as full crown coverage
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 injectorDental anesthesia injector | Procedure or surgery | Dental anesthesia injector group |
Primary outcome
Pain Score
Time frame: Baseline and immediate post-procedure
Wong-Baker FACES Pain Rating Scale, is a self-report measure consisting of a series of six facial expressions (FACES) representing increasing levels of pain. Scores range from 0 to 10, with 0 (happy face) indicating "no hurt" and 10 ( a crying face) indicating "hurts worst". Higher scores represent greater pain intensity and therefore a worse outcome.
Anxiety using the Modified Dental Anxiety Scale (MDAS)
Time frame: Baseline and immediate post- procedure
The Modified Dental Anxiety Scale is a self-reported measure of dental anxiety consisting of five items, each scored on a 5-point Likert scale. Total scores range from 5 to 25, with 5 indicating no dental anxiety and 25 indicating extreme dental anxiety. Higher scores represent greater dental anxiety and therefore a worse outcome.
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 18 Jun 2026.
- Individual participant dataSharing planned: No. Due to patient privacy
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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 Dental anesthesia injector in people with Pain and Anxiety, run by Shahad Abudawood at 1 site in Saudi Arabia.
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 3 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: finished, as of the sponsor's last update on 18 Jun 2026. 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 Saudi Arabia. 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?
Pain Score (time frame: Baseline and immediate post-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 18 Jun 2026.