Dental AnesthesiaNCT06892873
Clinical Evaluation and Comparison of Pain Acceptance of Different Types of Injection Systems
A study testing Comfort-In and Traditional dental injection in people with Dental Anesthesia, 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 4 to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Anesthesia
- What is being tested?
- Comfort-In 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
- 76 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 22 Jan 2024to 6 Sep 2024
- 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 4 to 11 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children aged 4-11 years
- Bilateral maxillary primary molars with an indication for extraction
- Not having taken any analgesics up to 12 hours before treatment
- Not having used antibiotics in the last month
- Teeth with at most 1/2 of the root physiologically resorbed
- Systemically healthy children
Show all 12Show fewer
- Those who agreed to participate in the study
- Those who scored 1-2-3-4 according to the Frankl behavior scale
- Frankl 1: Patients who refuse treatment, cry, are extremely fearful or show signs of severe negative behavior
- Frankl 2: Patients who are noncompliant, unwilling to receive treatment, show signs of unclear negative behavior, are sullen but do not express anxiety
- Frankl 3: Patients who accept treatment, are compliant, shy, establish a relationship with the physician but approach it moderately
- Frankl 4: Patients who cooperate with the physician, are curious about the treatment, smile and are happy with the environment (Frankl 1962)
Who cannot join
- If the infection has not spread beyond 1/3 of the root or furcation area
- If the root formation of the permanent tooth below is not complete or 2/3 root formation is not formed
- In the presence of dentigerous or follicular cysts
- Teeth with excessive material loss
- Teeth without permanent tooth germ underneath
- Teeth with suspected malignancy
Show all 11Show fewer
- Children who are not systemically healthy
- Patients with a previous history of allergy to local anesthetics
- If the teeth to be extracted will require surgical extraction during the procedure
- Acute infection status (clinically, the patient has any systemic findings such as mild or severe pain, swelling, trismus, fever, lymphadenopathy, weakness, headache or nausea)
- Those who do not accept to participate in the study
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Necmettin Erbakan University, Faculty of Dentistry
Konya, Meram, 42090
About this study
Official title: Clinical Evaluation and Comparison of Pain Acceptance of Different Types of Injection Systems in Palatal Anesthesia Applied to 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
The reason for wanting to conduct this research is that palatal injection, which is routinely used in the extraction of primary molars, causes pain and fear due to the tight connection between the palatal mucosa and the bone, and causes difficulty in tolerating it by pediatric patients. The aim of our research is to evaluate whether Comfort-in™ Needle-Free Injection, which can be used during palatal injection, can reduce injection pain. The palate side of the upper primary molars that require extraction treatment will be anesthetized with two different anesthesia techniques. One of these techniques will be applied with a needle and the other without a needle. The technique will be decided by determining which technique will be applied first using a random computer program. A 'popcorn sound' may occur during needle-free anesthesia, the investigators wanted to inform participants in advance so that participants are not surprised. The investigators also want to apply a scale called IDAF-4C to participants in order to learn the level of participants' concerns and fears about dentistry. The investigators plan to ask participants about this scale when participants first come to the clinic. After anesthetizing participants' teeth, the investigators will ask participants to evaluate the severity of pain with the Wong-Baker Pain Rating Scale. During female anesthesia, body responses will be recorded via video and then evaluated with the FLACC scale.
- Conditions
- Dental Anesthesia
- Being tested
- Comfort-In, Traditional dental injection
- Keywords
- Dental Anxiety, Jet Injection, Dental Injection, Pain Assessment, Palatal Infiltration Anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comfort-InDevice
Application of Comfort-in Jet Injection Method Comfort-in jet injection method was used for palatal anesthesia of the primary molars. The device was placed 5 mm below the palatal gingival margin, close to the free gingiva, and with a steep angle. 0.2 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. 38 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.
Traditional dental injectionOther
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 mL of anesthetic solution was stored when bone contact was removed. 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. 38 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 group | Role | What they receive |
|---|---|---|
| Application of Traditional Dental Injection Method | Active comparator | Conventional dental injection was applied. Receives: Other: Traditional dental injection |
| Application of Comfort-in Jet Injection Method | Experimental | Comfort-in Jet injection was applied. Receives: Device: Comfort-In |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Perception of Wong-Baker Scale
The investigators expect the comfort-in jet injection method to produce a lower score on the Wong-Baker pain scale than the traditional anesthesia method.The Wong-Baker pain scale is scored between 0-10. 0 means the patient has no pain and 10 means they feel very severe pain.
Measured: 1 minute after anesthesia application, the patient is asked to score the pain they feel.
Pain Perception of The Face, Legs, Activity, Cry, and Consolability (FLACC) scale
The investigators expect the comfort-in jet injection method to produce a lower score on the FLACC scale applied to pain acceptance in pediatric patients compared to the traditional anesthesia method. The FLACC pain scale is scored between 0-10. 0 means that the patients pain acceptance is good and 10 means that the pain acceptance is low.
Measured: The video was taken to examine the patient's body reactions during application of the anesthesia method. The data were evaluated up to 2 day.
Evaluation of physiological parameters with Pulse Oximetry
A finger-type pulse oximeter was used to measure pulse and oxygen saturation values. Data were recorded before and after anesthesia.
Measured: Data were recorded during applying anesthesia. Data were evaluated for up to 2 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2025
- Study start22 Jan 2024
- Primary completion30 Aug 2024
- Study completion6 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dental AnesthesiaStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 76 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, Principal investigator, halenuronat@gmail.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06892873
- Sponsor's protocol ID
- NecmettinEU04
- Status last verified
- Mar 2025
- First submitted
- 29 Nov 2024
- Last updated
- 25 Mar 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- 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 25 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation and Comparison of Pain Acceptance of Different Types of Injection Systems in Palatal Anesthesia Applied to Children
- ClinicalTrials.gov ID
- NCT06892873
- Acronym / sponsor ID
- NecmettinEU04
- Conditions
- Dental Anesthesia
- Keywords
- Dental Anxiety, Jet Injection, Dental Injection, Pain Assessment, Palatal Infiltration Anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Necmettin Erbakan UniversityUniversity, hospital or other
- Study start
- 22 Jan 2024 (actual)
- Primary completion
- 30 Aug 2024 (actual)
- Study completion
- 6 Sep 2024 (actual)
- First posted
- 25 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
The reason for wanting to conduct this research is that palatal injection, which is routinely used in the extraction of primary molars, causes pain and fear due to the tight connection between the palatal mucosa and the bone, and causes difficulty in tolerating it by pediatric patients. The aim of our research is to evaluate whether Comfort-in™ Needle-Free Injection, which can be used during palatal injection, can reduce injection pain. The palate side of the upper primary molars that require extraction treatment will be anesthetized with two different anesthesia techniques. One of these techniques will be applied with a needle and the other without a needle. The technique will be decided by determining which technique will be applied first using a random computer program. A 'popcorn sound' may occur during needle-free anesthesia, the investigators wanted to inform participants in advance so that participants are not surprised. The investigators also want to apply a scale called IDAF-4C to participants in order to learn the level of participants' concerns and fears about dentistry. The investigators plan to ask participants about this scale when participants first come to the clinic. After anesthetizing participants' teeth, the investigators will ask participants to evaluate the severity of pain with the Wong-Baker Pain Rating Scale. During female anesthesia, body responses will be recorded via video and then evaluated with the FLACC scale.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Application of Traditional Dental Injection Method | Active comparator | Other: Traditional dental injectionConventional dental injection was applied. |
| Application of Comfort-in Jet Injection Method | Experimental | Device: Comfort-InComfort-in Jet injection was applied. |
Who may qualify
- Ages
- 4 to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (12 listed)
- Children aged 4-11 years
- Bilateral maxillary primary molars with an indication for extraction
- Not having taken any analgesics up to 12 hours before treatment
- Not having used antibiotics in the last month
- Teeth with at most 1/2 of the root physiologically resorbed
Key exclusion criteria (11 listed)
- If the infection has not spread beyond 1/3 of the root or furcation area
- If the root formation of the permanent tooth below is not complete or 2/3 root formation is not formed
- In the presence of dentigerous or follicular cysts
- Teeth with excessive material loss
- Teeth without permanent tooth germ underneath
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-InApplication of Comfort-in Jet Injection Method Comfort-in jet injection method was used for palatal anesthesia of the primary molars. The device was placed 5 mm below the palatal gingival margin, close to the free gingiva, and with a steep angle. 0.2 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. 38 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. | Device | Application of Comfort-in Jet Injection Method |
| 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 mL of anesthetic solution was stored when bone contact was removed. 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. 38 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. | Other | Application of Traditional Dental Injection Method |
Primary outcome
Pain Perception of Wong-Baker Scale
Time frame: 1 minute after anesthesia application, the patient is asked to score the pain they feel.
The investigators expect the comfort-in jet injection method to produce a lower score on the Wong-Baker pain scale than the traditional anesthesia method.The Wong-Baker pain scale is scored between 0-10. 0 means the patient has no pain and 10 means they feel very severe pain.
Pain Perception of The Face, Legs, Activity, Cry, and Consolability (FLACC) scale
Time frame: The video was taken to examine the patient's body reactions during application of the anesthesia method. The data were evaluated up to 2 day.
The investigators expect the comfort-in jet injection method to produce a lower score on the FLACC scale applied to pain acceptance in pediatric patients compared to the traditional anesthesia method. The FLACC pain scale is scored between 0-10. 0 means that the patients pain acceptance is good and 10 means that the pain acceptance is low.
Evaluation of physiological parameters with Pulse Oximetry
Time frame: Data were recorded during applying anesthesia. Data were evaluated for up to 2 days.
A finger-type pulse oximeter was used to measure pulse and oxygen saturation values. Data were recorded before and after anesthesia.
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 25 Mar 2025.
- 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.
- 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 principal investigator
halenuronat@gmail.com
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 and Traditional dental injection in people with Dental Anesthesia, 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 12 inclusion and 11 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 25 Mar 2025. 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 Perception of Wong-Baker Scale (time frame: 1 minute after anesthesia application, the patient is asked to score the pain they feel.). The study lists 3 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 NCT06892873, 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 25 Mar 2025.