Physiological Effects of DrugsNCT06606587
Effectiveness of the Comfort-In Needle Free Injection System During Palatal Infiltrative Anesthesia
A study testing Comfort-in Jet Injection Method and Traditional Dental Injection in people with Physiological Effects of Drugs and Anesthetics, run by Necmettin Erbakan University at 1 site in Turkey (Türkiye).
Trial summary
The goal of this randomized clinical trial is to compare two different injection methods in children. The main question it aims to answer is: Is the needle-free injection method more painless than the traditional dental method? Two different methods will be used for children to perform anesthesia for extraction… Read more about this study
- Who is it for?
- Ages 6 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Physiological Effects of Drugs, Anesthetics
- What is being tested?
- Comfort-in Jet Injection Method and Traditional Dental Injection
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2023to 1 Dec 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 16 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Child patient between the ages of 6-16, Requiring extraction of maxillary permanent molars and premolars with bilateral palatal infiltration anesthesia, Showing "positive" and "definitely positive" behavior during examination according to the Frankl scale, Family volunteers, No medical or developmental disease
Who cannot join
- If there are medical or developmental disorders, If there is a chronic disease, If there is an allergy to anesthetic solutions, If there is any pathology in the anesthesia area, If the Frankl scale is "negative" and "definitely negative", If the mouth opening is not sufficient, If there is no need for symmetrical treatment in the teeth
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
: Halenur Altan, assoc. prof.
Konya, Meram, 42090
About this study
Official title: Evaluation of the Effectiveness of the Comfort-In Needle-Free Injector System During Palatal Infiltrative Anesthesia in Children
The goal of this randomized clinical trial is to compare two different injection methods in children. The main question it aims to answer is:
Is the needle-free injection method more painless than the traditional dental method?
Two different methods will be used for children to perform anesthesia for extraction permanent molars.
Read the detailed description
Study Groups and Study Design: 50 volunteer children between the ages of 6-15 who applied to Faculty of Dentistry Department of Pedodontics clinic with their parents were included in our study. Volunteer children with an indication for maxillary permanent first molar tooth extraction were randomly divided into two groups and included in the study. For randomization, methods were written on two different envelopes and the child was allowed to choose the envelope. The child was assigned to the selected method. Group Control: Application of Traditional Dental Injection Method Palatal injection; It was applied 5-10 mm below the palatal gingival margin*, on the attached gum, and with a 45-degree needle angle. After needle entry, 0.2-0.3 mL of anesthetic solution was stored when bone contact was removed (3-5 mm). 1 mL Articaine Hydrochloride (Ultracaine D-S forte, Hoechst, Canada) containing 1/100,000 epinephrine and a 27 G dental needle were used as local anesthetic agents for injections. 25 patients were included in this group and the procedure was performed. After waiting for 5 minutes, the anesthetized area was probed with the help of a probe (probing gingiva) to check whether the anesthesia had taken effect. Afterwards, buccal infiltration anesthesia was performed with the help of a traditional dental injector and tooth extraction was performed. Group Experimental: Application of Comfort-in Jet Injection Method Comfort-in jet injection method was used for palatal anesthesia of the permanent 1st molar. Using a silicone flat cap, it was placed 5 mm below the palatal gingival margin, close to the free gingiva, and with a steep angle. 0.3 ml of anesthetic solution was administered by pressing the jet injection system button. 1 mL Articaine Hydrochloride (Ultracaine D-S forte, Hoechst, Canada) containing 1/100,000 epinephrine was used as a local anesthetic agent in the injections. 25 patients were included in this group and the procedure was performed. After waiting for 2 minutes, the anesthetized area was probed with the help of a probe (probing gingiva) to check whether the anesthesia had taken effect. Afterwards, buccal infiltration anesthesia was performed with the help of a traditional dental injector and tooth extraction was performed.
- Conditions
- Physiological Effects of Drugs, Anesthetics
- Being tested
- Comfort-in Jet Injection Method, Traditional Dental Injection
- Keywords
- Comfort-In, Dental anxiety, Needle-free injection, Palatal infiltrative anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comfort-in Jet Injection MethodDevice
Application of Comfort-in Jet Injection Method: Comfort-in jet injection method was used for palatal anesthesia of the permanent 1st molar.
Traditional Dental InjectionOther
Application of Traditional Dental Injection Method: Traditional Dental Injection method was used for palatal anesthesia of the permanent 1st molar.
| Study group | Role | What they receive |
|---|---|---|
| Group Experimental: Application of Comfort-in Jet Injection Method | Experimental | Application of Comfort-in Jet Injection Method Comfort-in jet injection method was used for palatal anesthesia of the permanent 1st molar. Using a silicone flat cap, it was placed 5 mm below the palatal gingival margin, close to the free gingiva, and with a steep angle. 0.3 ml of anesthetic solution was administered by pressing the jet injection system button. 1 mL Articaine Hydrochloride (Ultracaine D-S forte, Hoechst, Canada) containing 1/100,000 epinephrine was used as a local anesthetic agent in the injections. 25 patients were included in this group and the procedure was performed. After waiting for 2 minutes, the anesthetized area was probed with the help of a probe (probing gingiva) to check whether the anesthesia had taken effect. Afterwards, buccal infiltration anesthesia was performed with the help of a traditional dental injector and tooth extraction was performed. Receives: Device: Comfort-in Jet Injection Method |
| Group Control: Application of Traditional Dental Injection Method | Other | Application of Traditional Dental Injection Method Palatal injection; It was applied 5-10 mm below the palatal gingival margin*, on the attached gum, and with a 45-degree needle angle. After needle entry, 0.2-0.3 mL of anesthetic solution was stored when bone contact was removed (3-5 mm). 1 mL Articaine Hydrochloride (Ultracaine D-S forte, Hoechst, Canada) containing 1/100,000 epinephrine and a 27 G dental needle were used as local anesthetic agents for injections. 25 patients were included in this group and the procedure was performed. After waiting for 5 minutes, the anesthetized area was probed with the help of a probe (probing gingiva) to check whether the anesthesia had taken effect. Afterwards, buccal infiltration anesthesia was performed with the help of a traditional dental injector and tooth extraction was performed. Receives: Other: Traditional Dental Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Perception Measured by the Wong-Baker FACES Pain Rating Scale
Pain perception was assessed using the Wong-Baker FACES Pain Rating Scale. The scale ranges from 0 to 10, where 0 represents no pain and 10 represents the worst pain imaginable. Higher scores indicate greater pain intensity.
Measured: Immediately after the anesthesia is administered
Pain Perception Measured by the Face, Legs, Activity, Cry, and Consolability (FLACC) Scale
Pain perception was assessed using the Face, Legs, Activity, Cry, and Consolability (FLACC) scale. The scale ranges from 0 to 10, where 0 indicates no pain and 10 indicates the highest level of pain. Higher scores indicate worse outcomes (greater pain intensity). Behavioral responses during the injection were video-recorded and later evaluated.
Measured: During the administration of the palatal anesthesia injection.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2024
- Study start1 Jan 2023
- Primary completion1 Nov 2023
- Study completion1 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Physiological Effects of DrugsStudies of the same condition, open and under way.
- More trials run by Necmettin Erbakan 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
- Parallel groups
- Model description
- Participants meeting the inclusion criteria were randomly assigned to one of two groups. To ensure randomization, two sealed envelopes, each containing one of the anesthesia methods, were prepared. One envelope contained "Group 1" and the other contained "Group 2". Each participant selected an envelope, determining their assigned anesthesia technique. In Group 1, palatal anesthesia was administered using the Comfort-In™ jet injection system, while in Group 2, a dental needle injection was used.
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Necmettin Erbakan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Halenur Altan, Necmettin Erbakan University
- Investigators
- Halenur Altan, Study chair, Necmetttin Erbakan University Dentistry Faculty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06606587
- Sponsor's protocol ID
- NecmettinEU02
- Status last verified
- Apr 2026
- First submitted
- 15 Aug 2024
- Last updated
- 30 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Altan 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 34852779
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effectiveness of the Comfort-In Needle-Free Injector System During Palatal Infiltrative Anesthesia in Children
- ClinicalTrials.gov ID
- NCT06606587
- Acronym / sponsor ID
- NecmettinEU02
- Conditions
- Physiological Effects of Drugs, Anesthetics
- Keywords
- Comfort-In, Dental anxiety, Needle-free injection, Palatal infiltrative anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Necmettin Erbakan UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 1 Nov 2023 (actual)
- Study completion
- 1 Dec 2023 (actual)
- First posted
- 23 Sep 2024 (actual)
- Results
- Posted 30 Apr 2026
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 randomized clinical trial is to compare two different injection methods in children. The main question it aims to answer is:
Is the needle-free injection method more painless than the traditional dental method?
Two different methods will be used for children to perform anesthesia for extraction permanent molars.
Detailed description
Study Groups and Study Design: 50 volunteer children between the ages of 6-15 who applied to Faculty of Dentistry Department of Pedodontics clinic with their parents were included in our study. Volunteer children with an indication for maxillary permanent first molar tooth extraction were randomly divided into two groups and included in the study. For randomization, methods were written on two different envelopes and the child was allowed to choose the envelope. The child was assigned to the selected method. Group Control: Application of Traditional Dental Injection Method Palatal injection; It was applied 5-10 mm below the palatal gingival margin*, on the attached gum, and with a 45-degree needle angle. After needle entry, 0.2-0.3 mL of anesthetic solution was stored when bone contact was removed (3-5 mm). 1 mL Articaine Hydrochloride (Ultracaine D-S forte, Hoechst, Canada) containing 1/100,000 epinephrine and a 27 G dental needle were used as local anesthetic agents for injections. 25 patients were included in this group and the procedure was performed. After waiting for 5 minutes, the anesthetized area was probed with the help of a probe (probing gingiva) to check whether the anesthesia had taken effect. Afterwards, buccal infiltration anesthesia was performed with the help of a traditional dental injector and tooth extraction was performed. Group Experimental: Application of Comfort-in Jet Injection Method Comfort-in jet injection method was used for palatal anesthesia of the permanent 1st molar. Using a silicone flat cap, it was placed 5 mm below the palatal gingival margin, close to the free gingiva, and with a steep angle. 0.3 ml of anesthetic solution was administered by pressing the jet injection system button. 1 mL Articaine Hydrochloride (Ultracaine D-S forte, Hoechst, Canada) containing 1/100,000 epinephrine was used as a local anesthetic agent in the injections. 25 patients were included in this group and the procedure was performed. After waiting for 2 minutes, the anesthetized area was probed with the help of a probe (probing gingiva) to check whether the anesthesia had taken effect. Afterwards, buccal infiltration anesthesia was performed with the help of a traditional dental injector and tooth extraction was performed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants meeting the inclusion criteria were randomly assigned to one of two groups. To ensure randomization, two sealed envelopes, each containing one of the anesthesia methods, were prepared. One envelope contained "Group 1" and the other contained "Group 2". Each participant selected an envelope, determining their assigned anesthesia technique. In Group 1, palatal anesthesia was administered using the Comfort-In™ jet injection system, while in Group 2, a dental needle injection was used.
| Arm | Type | Receives |
|---|---|---|
| Group Experimental: Application of Comfort-in Jet Injection Method | Experimental | Device: Comfort-in Jet Injection MethodApplication of Comfort-in Jet Injection Method Comfort-in jet injection method was used for palatal anesthesia of the permanent 1st molar. Using a silicone flat cap, it was placed 5 mm below the palatal gingival margin, close to the free gingiva, and with a steep angle. 0.3 ml of anesthetic solution was administered by pressing the jet injection system button. 1 mL Articaine Hydrochloride (Ultracaine D-S forte, Hoechst, Canada) containing 1/100,000 epinephrine was used as a local anesthetic agent in the injections. 25 patients were included in this group and the procedure was performed. After waiting for 2 minutes, the anesthetized area was probed with the help of a probe (probing gingiva) to check whether the anesthesia had taken effect. Afterwards, buccal infiltration anesthesia was performed with the help of a traditional dental injector and tooth extraction was performed. |
| Group Control: Application of Traditional Dental Injection Method | Other | Other: Traditional Dental InjectionApplication of Traditional Dental Injection Method Palatal injection; It was applied 5-10 mm below the palatal gingival margin*, on the attached gum, and with a 45-degree needle angle. After needle entry, 0.2-0.3 mL of anesthetic solution was stored when bone contact was removed (3-5 mm). 1 mL Articaine Hydrochloride (Ultracaine D-S forte, Hoechst, Canada) containing 1/100,000 epinephrine and a 27 G dental needle were used as local anesthetic agents for injections. 25 patients were included in this group and the procedure was performed. After waiting for 5 minutes, the anesthetized area was probed with the help of a probe (probing gingiva) to check whether the anesthesia had taken effect. Afterwards, buccal infiltration anesthesia was performed with the help of a traditional dental injector and tooth extraction was performed. |
Who may qualify
- Ages
- 6 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Child patient between the ages of 6-16, Requiring extraction of maxillary permanent molars and premolars with bilateral palatal infiltration anesthesia, Showing "positive" and "definitely positive" behavior during examination according to the Frankl scale, Family volunteers, No medical or developmental disease
Key exclusion criteria (1 listed)
- If there are medical or developmental disorders, If there is a chronic disease, If there is an allergy to anesthetic solutions, If there is any pathology in the anesthesia area, If the Frankl scale is "negative" and "definitely negative", If the mouth opening is not sufficient, If there is no need for symmetrical treatment in the teeth
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 Jet Injection MethodApplication of Comfort-in Jet Injection Method: Comfort-in jet injection method was used for palatal anesthesia of the permanent 1st molar. | Device | Group Experimental: Application of Comfort-in Jet Injection Method |
| Traditional Dental InjectionApplication of Traditional Dental Injection Method: Traditional Dental Injection method was used for palatal anesthesia of the permanent 1st molar. | Other | Group Control: Application of Traditional Dental Injection Method |
Primary outcome
Pain Perception Measured by the Wong-Baker FACES Pain Rating Scale
Time frame: Immediately after the anesthesia is administered
Pain perception was assessed using the Wong-Baker FACES Pain Rating Scale. The scale ranges from 0 to 10, where 0 represents no pain and 10 represents the worst pain imaginable. Higher scores indicate greater pain intensity.
Pain Perception Measured by the Face, Legs, Activity, Cry, and Consolability (FLACC) Scale
Time frame: During the administration of the palatal anesthesia injection.
Pain perception was assessed using the Face, Legs, Activity, Cry, and Consolability (FLACC) scale. The scale ranges from 0 to 10, where 0 indicates no pain and 10 indicates the highest level of pain. Higher scores indicate worse outcomes (greater pain intensity). Behavioral responses during the injection were video-recorded and later evaluated.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: 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.
- Individual participant dataSharing planned: No
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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.
Halenur Altan study chair
Necmetttin Erbakan University Dentistry Faculty
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 Jet Injection Method and Traditional Dental Injection in people with Physiological Effects of Drugs and Anesthetics, run by Necmettin Erbakan 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 1 inclusion and 1 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 30 Apr 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?
Yes. Results are posted in the registry (first posted 30 Apr 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Measured by the Wong-Baker FACES Pain Rating Scale (time frame: Immediately after the anesthesia is administered). 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 NCT06606587, 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 30 Apr 2026.