Pain Perception of the New DeviceNCT07498621
Assessment of Maxillary Local Anesthesia Infiltration Using Needle-free Jet vs Conventional Syringe in Tooth Extraction
A study testing needle-free anesthesia jet (Comfort-in™) and Conventional dental syringe injection in people with Pain Perception of the New Device, run by King Abdulaziz University at 1 site in Saudi Arabia.
Trial summary
Managing pain and anxiety during dental anesthesia remains a key concern, particularly in procedures involving needle-sensitive adult patients. Needle-free jet injection systems, such as Comfort- InTM, offer a potential alternative to conventional syringes by minimizing invasiveness and enhancing patient comfort… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain Perception of the New Device
- What is being tested?
- needle-free anesthesia jet (Comfort-in™) and Conventional dental syringe injection
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 1 Jan 2025to 30 Jul 2025
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- KAUDH patients aged 18 to 65 years.
- Bilateral posterior dentition suitable for the split-mouth technique.
- Classified as American Society of Anesthesiologists (ASA) I or ASA II.
Who cannot join
- Pediatric patients (<18 years).
- Medically compromised individuals.
- Patients with unilateral teeth indicated for extraction,
- Patient with upper anterior teeth requiring a nasopalatine nerve block.
- Patient with lower teeth requiring a nerve block.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Maxillary Local Anesthesia Infiltration Efficiency and Adult Patient Satisfaction: Needle-free Jet vs Conventional Syringe in Simple Tooth Extraction in a Single-blinded, Randomized Controlled Trial
Managing pain and anxiety during dental anesthesia remains a key concern, particularly in procedures involving needle-sensitive adult patients. Needle-free jet injection systems, such as Comfort- InTM, offer a potential alternative to conventional syringes by minimizing invasiveness and enhancing patient comfort during simple tooth extractions.
Read the detailed description
the study aimed to compare the efficacy, patient comfort, and pain perception between the conventional syringe injection technique and the needle-free jet injection system (Comfort-In) in dental anesthesia for simple tooth extractions.
- Conditions
- Pain Perception of the New Device
- Being tested
- needle-free anesthesia jet (Comfort-in™), Conventional dental syringe injection
- Keywords
- Dental Syringe, Needle-free jet, Tooth Extraction, Anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
needle-free anesthesia jet (Comfort-in™)Device
Dental needle-free anesthesia jet (Comfort-in™)
Conventional dental syringe injectionDevice
Conventional dental syringe injection
| Study group | Role | What they receive |
|---|---|---|
| Standard needle injection dental syringe | Active comparator | Not described Receives: Device: Conventional dental syringe injection |
| Needle free injector | Active comparator | Not described Receives: Device: needle-free anesthesia jet (Comfort-in™) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain perception survey
Pain levels were recorded using the Visual Analog Scale (VAS) in a survey after the extraction procedures. VAS scores were measured by asking patients to mark their pain level on a 1-10 line, and these pain scores were summarized using means and standard deviations (SD), and medians with interquartile ranges (IQR). ( 1 low pain, 10 worst pain)
Measured: From enrollment to the end of assessment of treatment at 24 weeks
Pain perception survey
Pain levels were recorded using the Numerical Rating Scale (NRS) in a survey after the extraction procedures. NRS scores were recorded verbally by the patient on a scale from 0 to 10, and these pain scores were summarized using means and standard deviations (SD), and medians with interquartile ranges (IQR). ( 0 is low pain, 10 worst pain)
Measured: From enrollment to the end of assessment of treatment at 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2026
- Study start1 Jan 2025
- Primary completion30 Jun 2025
- Study completion30 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for Pain Perception of the New DeviceStudies 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
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Abdulaziz University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ghassan Darwish, King Abdulaziz University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07498621
- Sponsor's protocol ID
- 190-11-24
- Status last verified
- Mar 2026
- First submitted
- 14 Mar 2026
- Last updated
- 27 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The study completed by one center and no data of individual patient data required to be shared
Publications
Alsbrooks K, Hoerauf K. Prevalence, causes, impacts, and management of needle phobia: An international survey of a general adult population. PLoS One. 2022 Nov 21;17(11):e0276814. doi: 10.1371/journal.pone.0276814. eCollection 2022.
PubMed 36409734Kuzin AV. [Practical advices in choosing local anesthesia tools in dentistry. Management of carpule's quality in local anesthesia in dentistry]. Stomatologiia (Mosk). 2014;93(2):37-9. Russian.
PubMed 24781127Ravi AD, Sadhna D, Nagpaal D, Chawla L. Needle free injection technology: A complete insight. Int J Pharm Investig. 2015 Oct-Dec;5(4):192-9. doi: 10.4103/2230-973X.167662.
PubMed 26682189Queralt CB, Comet V Jr, Cruz JM, Val-Carreres C. Local anesthesia by jet-injection device in minor dermatologic surgery. Dermatol Surg. 1995 Jul;21(7):649-51. doi: 10.1111/j.1524-4725.1995.tb00524.x.
PubMed 7606381Munshi AK, Hegde A, Bashir N. Clinical evaluation of the efficacy of anesthesia and patient preference using the needle-less jet syringe in pediatric dental practice. J Clin Pediatr Dent. 2001 Winter;25(2):131-6. doi: 10.17796/jcpd.25.2.q6426p853266q575.
PubMed 11314212Makade CS, Shenoi PR, Gunwal MK. Comparison of acceptance, preference and efficacy between pressure anesthesia and classical needle infiltration anesthesia for dental restorative procedures in adult patients. J Conserv Dent. 2014 Mar;17(2):169-74. doi: 10.4103/0972-0707.128063.
PubMed 24778516Belevcikli M, Altan H, Demir O. Effect of the new needle-free injection system on pain perception and dental anxiety during anesthesia: randomized controlled split-mouth study. J Dent Anesth Pain Med. 2023 Feb;23(1):1-8. doi: 10.17245/jdapm.2023.23.1.1. Epub 2023 Jan 30.
PubMed 36819599Altan A, Altan H, Almas B, Şahin ND. The effectiveness of a needle-free system in reducing injection pain during palatal infiltrative anesthesia in children: a randomized clinical study. J Clin Pediatr Dent 2025; 1:11.
Brunton PA, McLean M, Vedagiri S, McKeage J, Ruddy B, Weatherly K, White D, Taberner A, Loch C. Jet injection needle-free dental anaesthesia: Initial findings. J Dent. 2022 Jul;122:104165. doi: 10.1016/j.jdent.2022.104165. Epub 2022 May 14.
PubMed 35580835Shankar P, Chellathurai BNK, Kumar SA, Mahendra J, Mugri MH, Sayed M, Almagbol M, Al Wadei MHD, Vijayalakshmi R, Ambalavanan N, Raj AT, Patil S. A Comparison in Patient Comfort Using Conventional Syringe and Needleless Jet Anesthesia Technique in Periodontal Surgery-A Split-Mouth Randomized Clinical Trial. Medicina (Kaunas). 2022 Feb 12;58(2):278. doi: 10.3390/medicina58020278.
PubMed 35208601Saglam H, Karatas E. Anesthetic Efficacy, Injection Pain and Pulse-rate Effect of Needle-free Injection in Pulpal Anesthesia of Maxillary Premolars with Irreversible Pulpitis: Randomised Clinical Study. Eur Endod J. 2025 May;10(3):181-187. doi: 10.14744/eej.2025.26566.
PubMed 40464530Trimzi MA, Ham YB. A Needle-Free Jet Injection System for Controlled Release and Repeated Biopharmaceutical Delivery. Pharmaceutics. 2021 Oct 22;13(11):1770. doi: 10.3390/pharmaceutics13111770.
PubMed 34834185Eren F, Peker MS, Bekiroglu GN, Ozgur EG, Kargul B. The effect of a needle-free injection system on dental injection pain in children: a randomised cross-over clinical trial. J Clin Pediat Dentistry 2025; 49:128-139.
Alameeri AA, AlShamsi HA, Murad A, Alhammadi MM, Alketbi MH, AlHamwi A, Rawi NHA, Kawas SA, Mohammed MM, Shetty SR. The feasibility of needleless jet injection versus conventional needle local anesthesia during dental procedures: a systematic review. J Korean Assoc Oral Maxillofac Surg. 2022 Dec 31;48(6):331-341. doi: 10.5125/jkaoms.2022.48.6.331.
PubMed 36579904Kumal M, Shah A, Karn K, Kandel K, Paneru A, Subedi K. Prevalence of dental anxiety and its associated factors among patients visiting tertiary care dental hospital in Kathmandu, Nepal: a cross-sectional study. BMJ Open. 2025 Aug 1;15(7):e103762. doi: 10.1136/bmjopen-2025-103762.
PubMed 40750288
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Maxillary Local Anesthesia Infiltration Efficiency and Adult Patient Satisfaction: Needle-free Jet vs Conventional Syringe in Simple Tooth Extraction in a Single-blinded, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07498621
- Acronym / sponsor ID
- 190-11-24
- Conditions
- Pain Perception of the New Device
- Keywords
- Dental Syringe, Needle-free jet, Tooth Extraction, Anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- King Abdulaziz UniversityUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 30 Jul 2025 (actual)
- First posted
- 27 Mar 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.
Managing pain and anxiety during dental anesthesia remains a key concern, particularly in procedures involving needle-sensitive adult patients. Needle-free jet injection systems, such as Comfort- InTM, offer a potential alternative to conventional syringes by minimizing invasiveness and enhancing patient comfort during simple tooth extractions.
Detailed description
the study aimed to compare the efficacy, patient comfort, and pain perception between the conventional syringe injection technique and the needle-free jet injection system (Comfort-In) in dental anesthesia for simple tooth extractions.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard needle injection dental syringe | Active comparator | Device: Conventional dental syringe injection |
| Needle free injector | Active comparator | Device: needle-free anesthesia jet (Comfort-in™) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- KAUDH patients aged 18 to 65 years.
- Bilateral posterior dentition suitable for the split-mouth technique.
- Classified as American Society of Anesthesiologists (ASA) I or ASA II.
Key exclusion criteria (5 listed)
- Pediatric patients (<18 years).
- Medically compromised individuals.
- Patients with unilateral teeth indicated for extraction,
- Patient with upper anterior teeth requiring a nasopalatine nerve block.
- Patient with lower teeth requiring a nerve block.
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 |
|---|---|---|
| needle-free anesthesia jet (Comfort-in™)Dental needle-free anesthesia jet (Comfort-in™) | Device | Needle free injector |
| Conventional dental syringe injectionConventional dental syringe injection | Device | Standard needle injection dental syringe |
Primary outcome
Pain perception survey
Time frame: From enrollment to the end of assessment of treatment at 24 weeks
Pain levels were recorded using the Visual Analog Scale (VAS) in a survey after the extraction procedures. VAS scores were measured by asking patients to mark their pain level on a 1-10 line, and these pain scores were summarized using means and standard deviations (SD), and medians with interquartile ranges (IQR). ( 1 low pain, 10 worst pain)
Pain perception survey
Time frame: From enrollment to the end of assessment of treatment at 24 weeks
Pain levels were recorded using the Numerical Rating Scale (NRS) in a survey after the extraction procedures. NRS scores were recorded verbally by the patient on a scale from 0 to 10, and these pain scores were summarized using means and standard deviations (SD), and medians with interquartile ranges (IQR). ( 0 is low pain, 10 worst pain)
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 27 Mar 2026.
- Background: PubMed 36409734Alsbrooks K, Hoerauf K. Prevalence, causes, impacts, and management of needle phobia: An international survey of a general adult population. PLoS One. 2022 Nov 21;17(11):e0276814. doi: 10.1371/journal.pone.0276814. eCollection 2022.
- Background: PubMed 24781127Kuzin AV. [Practical advices in choosing local anesthesia tools in dentistry. Management of carpule's quality in local anesthesia in dentistry]. Stomatologiia (Mosk). 2014;93(2):37-9. Russian.
- Background: PubMed 26682189Ravi AD, Sadhna D, Nagpaal D, Chawla L. Needle free injection technology: A complete insight. Int J Pharm Investig. 2015 Oct-Dec;5(4):192-9. doi: 10.4103/2230-973X.167662.
- Background: PubMed 7606381Queralt CB, Comet V Jr, Cruz JM, Val-Carreres C. Local anesthesia by jet-injection device in minor dermatologic surgery. Dermatol Surg. 1995 Jul;21(7):649-51. doi: 10.1111/j.1524-4725.1995.tb00524.x.
- Background: PubMed 11314212Munshi AK, Hegde A, Bashir N. Clinical evaluation of the efficacy of anesthesia and patient preference using the needle-less jet syringe in pediatric dental practice. J Clin Pediatr Dent. 2001 Winter;25(2):131-6. doi: 10.17796/jcpd.25.2.q6426p853266q575.
- Background: PubMed 24778516Makade CS, Shenoi PR, Gunwal MK. Comparison of acceptance, preference and efficacy between pressure anesthesia and classical needle infiltration anesthesia for dental restorative procedures in adult patients. J Conserv Dent. 2014 Mar;17(2):169-74. doi: 10.4103/0972-0707.128063.
- Background: PubMed 36819599Belevcikli M, Altan H, Demir O. Effect of the new needle-free injection system on pain perception and dental anxiety during anesthesia: randomized controlled split-mouth study. J Dent Anesth Pain Med. 2023 Feb;23(1):1-8. doi: 10.17245/jdapm.2023.23.1.1. Epub 2023 Jan 30.
- BackgroundAltan A, Altan H, Almas B, Şahin ND. The effectiveness of a needle-free system in reducing injection pain during palatal infiltrative anesthesia in children: a randomized clinical study. J Clin Pediatr Dent 2025; 1:11.
- Background: PubMed 35580835Brunton PA, McLean M, Vedagiri S, McKeage J, Ruddy B, Weatherly K, White D, Taberner A, Loch C. Jet injection needle-free dental anaesthesia: Initial findings. J Dent. 2022 Jul;122:104165. doi: 10.1016/j.jdent.2022.104165. Epub 2022 May 14.
- Background: PubMed 35208601Shankar P, Chellathurai BNK, Kumar SA, Mahendra J, Mugri MH, Sayed M, Almagbol M, Al Wadei MHD, Vijayalakshmi R, Ambalavanan N, Raj AT, Patil S. A Comparison in Patient Comfort Using Conventional Syringe and Needleless Jet Anesthesia Technique in Periodontal Surgery-A Split-Mouth Randomized Clinical Trial. Medicina (Kaunas). 2022 Feb 12;58(2):278. doi: 10.3390/medicina58020278.
- Background: PubMed 40464530Saglam H, Karatas E. Anesthetic Efficacy, Injection Pain and Pulse-rate Effect of Needle-free Injection in Pulpal Anesthesia of Maxillary Premolars with Irreversible Pulpitis: Randomised Clinical Study. Eur Endod J. 2025 May;10(3):181-187. doi: 10.14744/eej.2025.26566.
- Background: PubMed 34834185Trimzi MA, Ham YB. A Needle-Free Jet Injection System for Controlled Release and Repeated Biopharmaceutical Delivery. Pharmaceutics. 2021 Oct 22;13(11):1770. doi: 10.3390/pharmaceutics13111770.
- Individual participant dataSharing planned: No. The study completed by one center and no data of individual patient data required to be shared
Related trials for Pain Perception of the New Device
Not yet recruiting
Effect of Starpen Injection Device Versus Conventional Syringe During Anesthesia and Extraction of Primary Molars
Pain Perception of the New Device
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 needle-free anesthesia jet (Comfort-in™) and Conventional dental syringe injection in people with Pain Perception of the New Device, run by King Abdulaziz University 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 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: finished, as of the sponsor's last update on 27 Mar 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 perception survey (time frame: From enrollment to the end of assessment of treatment at 24 weeks). 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 NCT07498621, which also lists 20 linked publications.
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 27 Mar 2026.