Dental AnxietyNCT07585812
Comfort-in Needle-Free Injection System in Pediatric Dental Anesthesia
A study testing Comfort-in Needle-Free Injection System and Conventional Dental Injection in people with Dental Anxiety and Dental Pain, run by Ondokuz Mayıs University at 1 site in Turkey (Türkiye).
Trial summary
This randomized split-mouth clinical trial evaluated the efficacy of the Comfort-in needle-free injection system compared with conventional dental injection for local anesthesia during pulpotomy treatment in children. Read more about this study
- Who is it for?
- Ages 5 to 8 years
- Conditions the study is for
- Dental Anxiety, Dental Pain, Pulpotomy
- What is being tested?
- Comfort-in Needle-Free Injection System and Conventional Dental Injection
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2019to 31 Dec 2021
- 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 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged 5 to 8 years.
- Children requiring pulpotomy treatment of bilateral primary first molars located in either the maxilla or mandible.
- Children with no previous experience of local anesthesia or dental treatment.
- Children who showed positive or definitely positive behavior according to the Frankl Behavior Rating Scale during the initial examination.
- Children with no systemic disease.
- Children with no mental or cognitive disability.
- Children who had not used medications that could affect pain perception, including antibiotics or analgesics.
- Written informed consent obtained from the parents or legal guardians.
Who cannot join
- Previous dental treatment experience.
- Previous local anesthesia experience.
- Uncooperative behavior during the initial examination.
- Presence of systemic disease.
- Presence of mental or cognitive disability.
- Antibiotic use within the last month.
Show all 9Show fewer
- Analgesic use within the last 24 hours.
- Use of any medication that could influence pain perception.
- Refusal of parental or legal guardian consent.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Recep Tayyip Erdogan University
Rize, Rize Province, 53000
About this study
Official title: Assessing the Efficacy of the Comfort-in Needle-Free Injection System for Managing Pain and Anxiety During Pediatric Dental Injections: A Randomized Split-Mouth Clinical Trial
This randomized split-mouth clinical trial evaluated the efficacy of the Comfort-in needle-free injection system compared with conventional dental injection for local anesthesia during pulpotomy treatment in children.
Sixty children aged 5 to 8 years who required bilateral pulpotomy of primary first molars were included. Each participant received both anesthesia techniques in separate treatment sessions with an interval of at least one week. The order of anesthesia techniques was randomized: 30 children received conventional dental injection in the first session and Comfort-in needle-free injection in the second session, while the remaining 30 children received the interventions in the reverse order.
Read more
Pain perception during anesthesia administration and pulpotomy was assessed using the Face, Legs, Activity, Cry, Consolability scale and the Wong-Baker FACES Pain Rating Scale. Physiological parameters, including blood pressure, pulse, and oxygen saturation, were recorded before anesthesia, after anesthesia, and after pulpotomy. The amount of anesthetic solution used, duration of anesthetic effect, postoperative complications, and patient preference were also recorded.
The study was designed to determine whether the Comfort-in needle-free injection system could provide effective local anesthesia for pediatric pulpotomy while reducing injection-related pain, physiological stress responses, anesthetic volume, duration of postoperative numbness, and postoperative complications compared with conventional dental injection.
Read the detailed description
Local anesthesia administration is one of the major sources of pain, fear, and anxiety in pediatric dental patients. Conventional dental injections may cause discomfort due to needle penetration, tissue pressure, and deposition of anesthetic solution. These experiences may negatively affect child cooperation and future dental attendance. Needle-free injection systems have been developed as an alternative method to deliver local anesthetic solution without needle penetration.
This randomized split-mouth clinical trial compared the Comfort-in needle-free injection system with conventional dental injection in children requiring pulpotomy treatment of bilateral primary first molars. The split-mouth design was used to allow each child to serve as his or her own control, thereby reducing interindividual variability in pain perception and physiological responses.
A total of 60 children aged 5 to 8 years were included. All participants required pulpotomy treatment of bilateral primary first molars located in either the maxilla or mandible. Eligible children had no previous experience with local anesthesia or dental treatment, had no systemic disease or mental disability, had not used medications that could affect pain perception, and demonstrated positive or definitely positive behavior according to the Frankl Behavior Rating Scale during the initial examination.
Each child received both anesthesia techniques in two separate clinical sessions with a minimum interval of one week. In one session, conventional local anesthesia was administered using a dental injector after topical anesthetic application. In the other session, local anesthesia was administered using the Comfort-in needle-free injection system after topical anesthetic application. The sequence of interventions was randomized. Thirty children received conventional injection first and Comfort-in needle-free injection second; the remaining 30 children received Comfort-in needle-free injection first and conventional injection second.
In the conventional injection session, the injection site was dried and topical anesthetic spray was applied for 60 seconds. Local anesthetic solution containing articaine hydrochloride with epinephrine 1:100,000 was then administered using a 27-gauge dental injector. In the Comfort-in session, the injection site was similarly dried and topical anesthetic spray was applied for 60 seconds. Articaine hydrochloride with epinephrine 1:100,000 was administered using the Comfort-in needle-free injection system.
Pain during anesthesia administration and pulpotomy was assessed using two validated pediatric pain assessment tools: the Face, Legs, Activity, Cry, Consolability scale and the Wong-Baker FACES Pain Rating Scale. Physiological parameters, including systolic blood pressure, diastolic blood pressure, pulse, and oxygen saturation, were recorded before anesthesia, after anesthesia, and after pulpotomy. The total amount of anesthetic solution used, duration of anesthetic effect, postoperative complications, and the child's preference for anesthesia technique were also recorded.
The primary aim of the study was to compare pain perception during local anesthesia administration between the Comfort-in needle-free injection system and conventional dental injection. Secondary aims included comparing anesthetic efficacy during pulpotomy, physiological responses, amount of anesthetic solution required, duration of anesthetic effect, postoperative complications, and patient preference between the two anesthesia techniques.
- Conditions
- Dental Anxiety, Dental Pain, Pulpotomy, Local Anesthesia
- Being tested
- Comfort-in Needle-Free Injection System, Conventional Dental Injection
- Keywords
- Comfort-in, Needle-free injection, Dental local anesthesia, Conventional dental injection, Injection pain
- Medical subject headings
- Toothache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comfort-in Needle-Free Injection SystemDevice
The Comfort-in needle-free injection system was used to administer local anesthetic solution without needle penetration. After drying the injection site and applying topical anesthetic spray for 60 seconds, articaine hydrochloride with epinephrine 1:100,000 was administered using the Comfort-in system before pulpotomy treatment of the primary first molar.
Conventional Dental InjectionProcedure or surgery
Conventional local anesthesia was administered using a dental injector. After drying the injection site and applying topical anesthetic spray for 60 seconds, articaine hydrochloride with epinephrine 1:100,000 was administered using a 27-gauge dental injector before pulpotomy treatment of the primary first molar.
| Study group | Role | What they receive |
|---|---|---|
| Conventional Dental Injection First, Comfort-in Needle-Free Injection Second | Active comparator | Participants in this arm received conventional dental injection in the first treatment session and Comfort-in needle-free injection in the second treatment session. The two sessions were performed on contralateral primary first molars requiring pulpotomy, with a minimum interval of one week between sessions. Receives: Device: Comfort-in Needle-Free Injection System; Procedure: Conventional Dental Injection |
| Comfort-in Needle-Free Injection First, Conventional Dental Injection Second | Experimental | Participants in this arm received Comfort-in needle-free injection in the first treatment session and conventional dental injection in the second treatment session. The two sessions were performed on contralateral primary first molars requiring pulpotomy, with a minimum interval of one week between sessions. Receives: Device: Comfort-in Needle-Free Injection System; Procedure: Conventional Dental Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain during local anesthesia administration assessed by the FLACC scale
Pain-related behavior during local anesthesia administration was assessed using the Face, Legs, Activity, Cry, Consolability (FLACC) scale. The FLACC scale evaluates five behavioral categories: face, legs, activity, cry, and consolability. The total score ranges from 0 to 10, with higher scores indicating greater pain.
Measured: Periprocedural at Visit 1 and Visit 2, during local anesthesia administration; visits were separated by at least 1 week.
Secondary outcomes (10)
Pain during local anesthesia and pulpotomy assessed by the Wong-Baker FACES Pain Rating Scale
Self-reported pain was assessed using the Wong-Baker FACES Pain Rating Scale. Scores range from 0 to 10, with higher scores indicating greater pain. Pain scores were recorded after local anesthesia administration and after pulpotomy treatment for both anesthesia techniques.
Measured: Immediately after local anesthesia administration and immediately after pulpotomy in each treatment session
Pain during pulpotomy procedure steps assessed by the FLACC scale
Pain-related behavior during pulpotomy was assessed using the FLACC scale at different procedural steps, including high-speed instrumentation, low-speed instrumentation, pulp removal, matrix-wedge placement, and restoration. The total FLACC score ranges from 0 to 10, with higher scores indicating greater pain.
Measured: Periprocedural at Visit 1 and Visit 2, during prespecified pulpotomy procedure steps.
Systolic blood pressure
Systolic blood pressure was recorded as a physiological parameter to evaluate the response to the anesthesia technique and dental treatment.
Measured: Immediately before anesthesia, immediately after anesthesia, and immediately after pulpotomy in each treatment session
Diastolic blood pressure
Diastolic blood pressure was recorded as a physiological parameter to evaluate the response to the anesthesia technique and dental treatment.
Measured: Immediately before anesthesia, immediately after anesthesia, and immediately after pulpotomy in each treatment session
Pulse rate
Pulse rate was recorded as a physiological parameter to evaluate the response to the anesthesia technique and dental treatment.
Measured: Immediately before anesthesia, immediately after anesthesia, and immediately after pulpotomy in each treatment session
Oxygen saturation
Oxygen saturation was recorded as a physiological parameter during the dental treatment session.
Measured: Immediately before anesthesia, immediately after anesthesia, and immediately after pulpotomy in each treatment session
Total amount of anesthetic solution used
The total volume of local anesthetic solution used for each anesthesia technique was recorded in milliliters.
Measured: Periprocedural at Visit 1 and Visit 2, during local anesthesia administration.
Duration of anesthetic effect
The duration of anesthetic effect after local anesthesia administration was recorded in hours for each anesthesia technique.
Measured: Immediately after local anesthesia administration in each treatment session
Postoperative complications after local anesthesia
Postoperative complications after local anesthesia were recorded for each anesthesia technique. Complications included lip biting, swelling, hematoma, and pain.
Measured: Up to 24 hours after Visit 1 and Visit 2
Number of Participants Preferring Each Anesthesia Technique Assessed by a Direct Preference Question
After experiencing both anesthesia techniques, participants were asked which technique they preferred: conventional dental injection or Comfort-in needle-free injection. Data were reported as the number of participants preferring each anesthesia technique.
Measured: At completion of Visit 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2026
- Study start1 Jan 2019
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Dental AnxietyStudies of the same condition, open and under way.
- More trials run by Ondokuz Mayıs 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This was a randomized split-mouth clinical trial. Each participant received both anesthesia techniques in two separate treatment sessions with a minimum interval of one week. Participants were randomized to one of two intervention sequences: conventional dental injection followed by Comfort-in needle-free injection, or Comfort-in needle-free injection followed by conventional dental injection. Contralateral primary first molars requiring pulpotomy were treated in separate sessions.
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ondokuz Mayıs University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Semih Ercan Akgun, Ondokuz Mayıs University
- Investigators
- Sema Aydinoglu, DDS, PhD, Principal investigator, Recep Tayyip Erdogan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07585812
- Sponsor's protocol ID
- RTEU_2019/05
- Status last verified
- May 2026
- First submitted
- 30 Apr 2026
- Last updated
- 14 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared because the study included pediatric participants and specific consent for external sharing of individual participant-level data was not obtained. Aggregate study results will be reported in the manuscript.
Publications
Yildirim S, Tokuc M, Aydin MN. The effect of pre-anesthesia with a needle-free system versus topical anesthesia on injection pain of the inferior alveolar nerve block: a randomized clinical trial. Clin Oral Investig. 2020 Dec;24(12):4355-4361. doi: 10.1007/s00784-020-03301-9. Epub 2020 May 7.
PubMed 32382924Theocharidou A, Arhakis A, Kotsanos N, Arapostathis K. Jet or conventional local anaesthesia? A randomized controlled split mouth study. Clin Oral Investig. 2021 Dec;25(12):6813-6819. doi: 10.1007/s00784-021-03968-8. Epub 2021 Apr 28.
PubMed 33912990Arapostathis KN, Dabarakis NN, Coolidge T, Tsirlis A, Kotsanos N. Comparison of acceptance, preference, and efficacy between jet injection INJEX and local infiltration anesthesia in 6 to 11 year old dental patients. Anesth Prog. 2010 Spring;57(1):3-12. doi: 10.2344/0003-3006-57.1.3.
PubMed 20331333Altan H, Belevcikli M, Cosgun A, Demir O. Comparative evaluation of pain perception with a new needle-free system and dental needle method in children: a randomized clinical trial. BMC Anesthesiol. 2021 Dec 1;21(1):301. doi: 10.1186/s12871-021-01524-1.
PubMed 34852779Altan H, Almas B. Clinical evaluation of different types of injection systems and comparison of pain acceptance in palatal anesthesia in pediatric patients: a randomized controlled split-mouth study. J Dent Anesth Pain Med. 2025 Jun;25(3):191-199. doi: 10.17245/jdapm.2025.25.3.191. Epub 2025 May 30.
PubMed 40521423Sermet Elbay U, Elbay M, Yildirim S, Kaya E, Kaya C, Ugurluel C, BaydemIr C. Evaluation of the injection pain with the use of DentalVibe injection system during supraperiosteal anaesthesia in children: a randomised clinical trial. Int J Paediatr Dent. 2016 Sep;26(5):336-45. doi: 10.1111/ipd.12204. Epub 2015 Sep 15.
PubMed 26369274Elbay M, Sermet Elbay U, Yildirim S, Ugurluel C, Kaya C, Baydemir C. Comparison of injection pain caused by the DentalVibe Injection System versus a traditional syringe for inferior alveolar nerve block anaesthesia in paediatric patients. Eur J Paediatr Dent. 2015 Jun;16(2):123-8.
PubMed 26147818Makade 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 24778516Ocak H, Akkoyun EF, Colpak HA, Demetoglu U, Yucesoy T, Kilic E, Alkan A. Is the jet injection effective for teeth extraction? J Stomatol Oral Maxillofac Surg. 2020 Feb;121(1):19-24. doi: 10.1016/j.jormas.2019.05.001. Epub 2019 May 8.
PubMed 31077857Naik SS, Kodical SR, Joshi A, Mali S, Shah R, Shetiya N. Efficacy and Pain Perception of a Comfort-in for Palatal Anesthesia in Pediatric Dental Patients: A Randomized Controlled Trial. Int J Clin Pediatr Dent. 2026 Feb;19(2):228-233. doi: 10.5005/jp-journals-10005-3418. Epub 2026 Feb 12.
PubMed 41799997Oliveira ACA, Amorim KS, Nascimento Junior EMD, Duarte ACB, Groppo FC, Takeshita WM, Souza LMA. Assessment of anesthetic properties and pain during needleless jet injection anesthesia: a randomized clinical trial. J Appl Oral Sci. 2019 Jan 14;27:e20180195. doi: 10.1590/1678-7757-2018-0195.
PubMed 30673030Kanaa MD, Meechan JG, Corbett IP, Whitworth JM. Speed of injection influences efficacy of inferior alveolar nerve blocks: a double-blind randomized controlled trial in volunteers. J Endod. 2006 Oct;32(10):919-23. doi: 10.1016/j.joen.2006.04.004. Epub 2006 Jul 7.
PubMed 16982264Friedman MJ, Hochman MN. The AMSA injection: a new concept for local anesthesia of maxillary teeth using a computer-controlled injection system. Quintessence Int. 1998 May;29(5):297-303.
PubMed 9693648Al-Melh MA, Andersson L. Comparison of topical anesthetics (EMLA/Oraqix vs. benzocaine) on pain experienced during palatal needle injection. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2007 May;103(5):e16-20. doi: 10.1016/j.tripleo.2006.11.033. Epub 2007 Feb 27.
PubMed 17331753Amrollahi N, Rastghalam N, Faghihian R. EFFECT OF PRE-COOLING ON PAIN ASSOCIATED WITH DENTAL INJECTIONS IN CHILDREN: A SYSTEMATIC REVIEW. J Evid Based Dent Pract. 2021 Sep;21(3):101588. doi: 10.1016/j.jebdp.2021.101588. Epub 2021 Jun 4.
PubMed 34479670
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Efficacy of the Comfort-in Needle-Free Injection System for Managing Pain and Anxiety During Pediatric Dental Injections: A Randomized Split-Mouth Clinical Trial
- ClinicalTrials.gov ID
- NCT07585812
- Acronym / sponsor ID
- RTEU_2019/05
- Conditions
- Dental Anxiety, Dental Pain, Pulpotomy, Local Anesthesia
- Keywords
- Comfort-in, Needle-free injection, Dental local anesthesia, Conventional dental injection, Injection pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ondokuz Mayıs UniversityUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 14 May 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.
This randomized split-mouth clinical trial evaluated the efficacy of the Comfort-in needle-free injection system compared with conventional dental injection for local anesthesia during pulpotomy treatment in children.
Sixty children aged 5 to 8 years who required bilateral pulpotomy of primary first molars were included. Each participant received both anesthesia techniques in separate treatment sessions with an interval of at least one week. The order of anesthesia techniques was randomized: 30 children received conventional dental injection in the first session and Comfort-in needle-free injection in the second session, while the remaining 30 children received the interventions in the reverse order.
Pain perception during anesthesia administration and pulpotomy was assessed using the Face, Legs, Activity, Cry, Consolability scale and the Wong-Baker FACES Pain Rating Scale. Physiological parameters, including blood pressure, pulse, and oxygen saturation, were recorded before anesthesia, after anesthesia, and after pulpotomy. The amount of anesthetic solution used, duration of anesthetic effect, postoperative complications, and patient preference were also recorded.
The study was designed to determine whether the Comfort-in needle-free injection system could provide effective local anesthesia for pediatric pulpotomy while reducing injection-related pain, physiological stress responses, anesthetic volume, duration of postoperative numbness, and postoperative complications compared with conventional dental injection.
Detailed description
Local anesthesia administration is one of the major sources of pain, fear, and anxiety in pediatric dental patients. Conventional dental injections may cause discomfort due to needle penetration, tissue pressure, and deposition of anesthetic solution. These experiences may negatively affect child cooperation and future dental attendance. Needle-free injection systems have been developed as an alternative method to deliver local anesthetic solution without needle penetration.
This randomized split-mouth clinical trial compared the Comfort-in needle-free injection system with conventional dental injection in children requiring pulpotomy treatment of bilateral primary first molars. The split-mouth design was used to allow each child to serve as his or her own control, thereby reducing interindividual variability in pain perception and physiological responses.
A total of 60 children aged 5 to 8 years were included. All participants required pulpotomy treatment of bilateral primary first molars located in either the maxilla or mandible. Eligible children had no previous experience with local anesthesia or dental treatment, had no systemic disease or mental disability, had not used medications that could affect pain perception, and demonstrated positive or definitely positive behavior according to the Frankl Behavior Rating Scale during the initial examination.
Each child received both anesthesia techniques in two separate clinical sessions with a minimum interval of one week. In one session, conventional local anesthesia was administered using a dental injector after topical anesthetic application. In the other session, local anesthesia was administered using the Comfort-in needle-free injection system after topical anesthetic application. The sequence of interventions was randomized. Thirty children received conventional injection first and Comfort-in needle-free injection second; the remaining 30 children received Comfort-in needle-free injection first and conventional injection second.
In the conventional injection session, the injection site was dried and topical anesthetic spray was applied for 60 seconds. Local anesthetic solution containing articaine hydrochloride with epinephrine 1:100,000 was then administered using a 27-gauge dental injector. In the Comfort-in session, the injection site was similarly dried and topical anesthetic spray was applied for 60 seconds. Articaine hydrochloride with epinephrine 1:100,000 was administered using the Comfort-in needle-free injection system.
Pain during anesthesia administration and pulpotomy was assessed using two validated pediatric pain assessment tools: the Face, Legs, Activity, Cry, Consolability scale and the Wong-Baker FACES Pain Rating Scale. Physiological parameters, including systolic blood pressure, diastolic blood pressure, pulse, and oxygen saturation, were recorded before anesthesia, after anesthesia, and after pulpotomy. The total amount of anesthetic solution used, duration of anesthetic effect, postoperative complications, and the child's preference for anesthesia technique were also recorded.
The primary aim of the study was to compare pain perception during local anesthesia administration between the Comfort-in needle-free injection system and conventional dental injection. Secondary aims included comparing anesthetic efficacy during pulpotomy, physiological responses, amount of anesthetic solution required, duration of anesthetic effect, postoperative complications, and patient preference between the two anesthesia techniques.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This was a randomized split-mouth clinical trial. Each participant received both anesthesia techniques in two separate treatment sessions with a minimum interval of one week. Participants were randomized to one of two intervention sequences: conventional dental injection followed by Comfort-in needle-free injection, or Comfort-in needle-free injection followed by conventional dental injection. Contralateral primary first molars requiring pulpotomy were treated in separate sessions.
| Arm | Type | Receives |
|---|---|---|
| Conventional Dental Injection First, Comfort-in Needle-Free Injection Second | Active comparator | Device: Comfort-in Needle-Free Injection System, Procedure: Conventional Dental InjectionParticipants in this arm received conventional dental injection in the first treatment session and Comfort-in needle-free injection in the second treatment session. The two sessions were performed on contralateral primary first molars requiring pulpotomy, with a minimum interval of one week between sessions. |
| Comfort-in Needle-Free Injection First, Conventional Dental Injection Second | Experimental | Device: Comfort-in Needle-Free Injection System, Procedure: Conventional Dental InjectionParticipants in this arm received Comfort-in needle-free injection in the first treatment session and conventional dental injection in the second treatment session. The two sessions were performed on contralateral primary first molars requiring pulpotomy, with a minimum interval of one week between sessions. |
Who may qualify
- Ages
- 5 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Children aged 5 to 8 years.
- Children requiring pulpotomy treatment of bilateral primary first molars located in either the maxilla or mandible.
- Children with no previous experience of local anesthesia or dental treatment.
- Children who showed positive or definitely positive behavior according to the Frankl Behavior Rating Scale during the initial examination.
- Children with no systemic disease.
Key exclusion criteria (9 listed)
- Previous dental treatment experience.
- Previous local anesthesia experience.
- Uncooperative behavior during the initial examination.
- Presence of systemic disease.
- Presence of mental or cognitive disability.
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 |
|---|---|---|
| Comfort-in Needle-Free Injection SystemThe Comfort-in needle-free injection system was used to administer local anesthetic solution without needle penetration. After drying the injection site and applying topical anesthetic spray for 60 seconds, articaine hydrochloride with epinephrine 1:100,000 was administered using the Comfort-in system before pulpotomy treatment of the primary first molar. | Device | Comfort-in Needle-Free Injection First, Conventional Dental Injection Second, Conventional Dental Injection First, Comfort-in Needle-Free Injection Second |
| Conventional Dental InjectionConventional local anesthesia was administered using a dental injector. After drying the injection site and applying topical anesthetic spray for 60 seconds, articaine hydrochloride with epinephrine 1:100,000 was administered using a 27-gauge dental injector before pulpotomy treatment of the primary first molar. | Procedure or surgery | Comfort-in Needle-Free Injection First, Conventional Dental Injection Second, Conventional Dental Injection First, Comfort-in Needle-Free Injection Second |
Primary outcome
Pain during local anesthesia administration assessed by the FLACC scale
Time frame: Periprocedural at Visit 1 and Visit 2, during local anesthesia administration; visits were separated by at least 1 week.
Pain-related behavior during local anesthesia administration was assessed using the Face, Legs, Activity, Cry, Consolability (FLACC) scale. The FLACC scale evaluates five behavioral categories: face, legs, activity, cry, and consolability. The total score ranges from 0 to 10, with higher scores indicating greater pain.
10 secondary outcomes
Pain during local anesthesia and pulpotomy assessed by the Wong-Baker FACES Pain Rating Scale
Time frame: Immediately after local anesthesia administration and immediately after pulpotomy in each treatment session
Pain during pulpotomy procedure steps assessed by the FLACC scale
Time frame: Periprocedural at Visit 1 and Visit 2, during prespecified pulpotomy procedure steps.
Systolic blood pressure
Time frame: Immediately before anesthesia, immediately after anesthesia, and immediately after pulpotomy in each treatment session
Diastolic blood pressure
Time frame: Immediately before anesthesia, immediately after anesthesia, and immediately after pulpotomy in each treatment session
Pulse rate
Time frame: Immediately before anesthesia, immediately after anesthesia, and immediately after pulpotomy in each treatment session
Oxygen saturation
Time frame: Immediately before anesthesia, immediately after anesthesia, and immediately after pulpotomy in each treatment session
Total amount of anesthetic solution used
Time frame: Periprocedural at Visit 1 and Visit 2, during local anesthesia administration.
Duration of anesthetic effect
Time frame: Immediately after local anesthesia administration in each treatment session
Postoperative complications after local anesthesia
Time frame: Up to 24 hours after Visit 1 and Visit 2
Number of Participants Preferring Each Anesthesia Technique Assessed by a Direct Preference Question
Time frame: At completion of Visit 2
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 14 May 2026.
- Background: PubMed 32382924Yildirim S, Tokuc M, Aydin MN. The effect of pre-anesthesia with a needle-free system versus topical anesthesia on injection pain of the inferior alveolar nerve block: a randomized clinical trial. Clin Oral Investig. 2020 Dec;24(12):4355-4361. doi: 10.1007/s00784-020-03301-9. Epub 2020 May 7.
- Background: PubMed 33912990Theocharidou A, Arhakis A, Kotsanos N, Arapostathis K. Jet or conventional local anaesthesia? A randomized controlled split mouth study. Clin Oral Investig. 2021 Dec;25(12):6813-6819. doi: 10.1007/s00784-021-03968-8. Epub 2021 Apr 28.
- Background: PubMed 20331333Arapostathis KN, Dabarakis NN, Coolidge T, Tsirlis A, Kotsanos N. Comparison of acceptance, preference, and efficacy between jet injection INJEX and local infiltration anesthesia in 6 to 11 year old dental patients. Anesth Prog. 2010 Spring;57(1):3-12. doi: 10.2344/0003-3006-57.1.3.
- Background: PubMed 34852779Altan H, Belevcikli M, Cosgun A, Demir O. Comparative evaluation of pain perception with a new needle-free system and dental needle method in children: a randomized clinical trial. BMC Anesthesiol. 2021 Dec 1;21(1):301. doi: 10.1186/s12871-021-01524-1.
- Background: PubMed 40521423Altan H, Almas B. Clinical evaluation of different types of injection systems and comparison of pain acceptance in palatal anesthesia in pediatric patients: a randomized controlled split-mouth study. J Dent Anesth Pain Med. 2025 Jun;25(3):191-199. doi: 10.17245/jdapm.2025.25.3.191. Epub 2025 May 30.
- Background: PubMed 26369274Sermet Elbay U, Elbay M, Yildirim S, Kaya E, Kaya C, Ugurluel C, BaydemIr C. Evaluation of the injection pain with the use of DentalVibe injection system during supraperiosteal anaesthesia in children: a randomised clinical trial. Int J Paediatr Dent. 2016 Sep;26(5):336-45. doi: 10.1111/ipd.12204. Epub 2015 Sep 15.
- Background: PubMed 26147818Elbay M, Sermet Elbay U, Yildirim S, Ugurluel C, Kaya C, Baydemir C. Comparison of injection pain caused by the DentalVibe Injection System versus a traditional syringe for inferior alveolar nerve block anaesthesia in paediatric patients. Eur J Paediatr Dent. 2015 Jun;16(2):123-8.
- 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 31077857Ocak H, Akkoyun EF, Colpak HA, Demetoglu U, Yucesoy T, Kilic E, Alkan A. Is the jet injection effective for teeth extraction? J Stomatol Oral Maxillofac Surg. 2020 Feb;121(1):19-24. doi: 10.1016/j.jormas.2019.05.001. Epub 2019 May 8.
- Background: PubMed 41799997Naik SS, Kodical SR, Joshi A, Mali S, Shah R, Shetiya N. Efficacy and Pain Perception of a Comfort-in for Palatal Anesthesia in Pediatric Dental Patients: A Randomized Controlled Trial. Int J Clin Pediatr Dent. 2026 Feb;19(2):228-233. doi: 10.5005/jp-journals-10005-3418. Epub 2026 Feb 12.
- Background: PubMed 30673030Oliveira ACA, Amorim KS, Nascimento Junior EMD, Duarte ACB, Groppo FC, Takeshita WM, Souza LMA. Assessment of anesthetic properties and pain during needleless jet injection anesthesia: a randomized clinical trial. J Appl Oral Sci. 2019 Jan 14;27:e20180195. doi: 10.1590/1678-7757-2018-0195.
- Background: PubMed 16982264Kanaa MD, Meechan JG, Corbett IP, Whitworth JM. Speed of injection influences efficacy of inferior alveolar nerve blocks: a double-blind randomized controlled trial in volunteers. J Endod. 2006 Oct;32(10):919-23. doi: 10.1016/j.joen.2006.04.004. Epub 2006 Jul 7.
- Instruction Manual. Comfort-in™ Needle-Free Injection System \[Internet\]. \[cited Apr 16 2026\]. Available from: http://www.comfort-in. com/file/English-French%20manual.pdfLink provided by the sponsor.
- Individual participant dataSharing planned: No. Individual participant data will not be shared because the study included pediatric participants and specific consent for external sharing of individual participant-level data was not obtained. Aggregate study results will be reported in the manuscript.
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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.
Sema Aydinoglu, DDS, PhD principal investigator
Recep Tayyip Erdogan 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 Comfort-in Needle-Free Injection System and Conventional Dental Injection in people with Dental Anxiety and Dental Pain, run by Ondokuz Mayıs University at 1 site in Turkey (Türkiye).
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 8 inclusion and 9 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 14 May 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 Turkey (Türkiye). 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 during local anesthesia administration assessed by the FLACC scale (time frame: Periprocedural at Visit 1 and Visit 2, during local anesthesia administration; visits were separated by at least 1 week.). 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 NCT07585812, which also lists 17 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 14 May 2026.