PainNCT07846098
Comparison of Intraosseous Anesthesia and Inferior Alveolar Nerve Block for Primary Mandibular Molars
A study testing Inferior Alveolar Nerve Block and intraosseous anaesthesia in people with Pain and Dental Caries, run by Cumhuriyet University at 1 site in Turkey (Türkiye).
Trial summary
The aim of the present study is to compare computerized intra-osseous injection system to the conventional inferior alveolar nerve block in primary mandibular teeth. Read more about this study
- Who is it for?
- Ages 6 to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain, Dental Caries
- What is being tested?
- Inferior Alveolar Nerve Block and intraosseous anaesthesia
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 14 May 2026to 20 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 8 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children aged 6 to 8 years
- Systemically healthy (American Society of Anesthesiologists [ASA] physical status I)
- Positive or definitely positive behavior (Frankl Behavior Rating Scale score 3 or 4)
- Bilateral (contralateral) mandibular primary molars with deep dentin caries requiring treatment
- Able to attend a second appointment
- Written informed consent from a parent/legal guardian and assent from the child
Who cannot join
- Known allergy to local anesthetic solutions
- Use of analgesics within the last 24 hours
- Acute infection
- Gingivitis, oral fistula, abscess, or bone loss in the area where anesthesia will be administered
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Intraosseous Anesthesia and Inferior Alveolar Nerve Block for Primary Mandibular Molars: A Randomized Controlled Clinical Study
The aim of the present study is to compare computerized intra-osseous injection system to the conventional inferior alveolar nerve block in primary mandibular teeth.
Read the detailed description
This study is designed as a randomized controlled clinical trial. A total of 60 primary mandibular molars from 30 pediatric patients who present for routine dental treatment at the Department of Pediatric Dentistry, Faculty of Dentistry, Sivas Cumhuriyet University, will be included. The study will consist of two sessions for each patient, with the type of anesthesia determined through simple randomization. In one session, traditional inferior alveolar nerve block anesthesia will be administered using a traditional syringe, and in the other session, intraosseous anesthesia will be performed using the computer-controlled SleeperOne5 device.
During anesthesia administration, pain levels will be assessed using the Visual Analog Scale (VAS), patient satisfaction will be evaluated with the Facial Image Scale (FIS), and behavior will be scored using the Modified Venham Scale. Additionally, heart rate, the volume of anesthetic solution used, and onset time of anesthesia will be recorded for both techniques. Postoperative complications will be assessed one day after the treatment.
- Conditions
- Pain, Dental Caries
- Being tested
- Inferior Alveolar Nerve Block, intraosseous anaesthesia
- Keywords
- intraosseous anesthesia, inferior alveolar nerve block, primary molar teeth
- Medical subject headings
- Pain, Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inferior Alveolar Nerve BlockOther
inferior alveolar nerve block using Articaine 4% with 1/200000 Adrenaline and a traditional needle injection
intraosseous anaesthesiaOther
intraosseous anaesthesia using Articaine 4% with 1/200000 Adrenaline and a special intraosseous injection device
| Study group | Role | What they receive |
|---|---|---|
| inferior alveolar nerve block | Active comparator | Conventional inferior alvoelar nerve block anaesthesia will be given using a traditional metal syringe Receives: Other: Inferior Alveolar Nerve Block |
| intraosseous anaesthesia | Experimental | Computerized intraosseous anesthesia administration using SleeperOne5 Receives: Other: intraosseous anaesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Intensity Measured by Visual Analog Scale (VAS)
Pain intensity will be assessed using the Visual Analog Scale (VAS), a 10-cm horizontal line ranging from 0 (no pain) to 10 (worst possible pain). Scores range from 0 to 10, with higher scores indicating greater pain.
Measured: Immediately after anesthetic injection and during dental treatment (Day 1)
Secondary outcomes (2)
Heart Rate
Heart rate will be measured in beats per minute (bpm) using a pulse oximeter.
Measured: Immediately before injection (baseline), during injection, and immediately after injection (Day 1)
Dental Anxiety and Behavior Measured by Venham Clinical Anxiety Rating Scale
Anxiety and behavior will be evaluated using the Venham Clinical Anxiety Rating Scale. Scores range from 0 (relaxed, cooperative) to 5 (out of contact, no response to verbal commands), with higher scores indicating greater anxiety and less cooperative behavior.
Measured: Immediately after anesthetic injection and during dental treatment (Day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2026
- Study start14 May 2026
- Primary completion20 Nov 2026 (estimated)
- Study completion20 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cumhuriyet University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arzu Koçkanat, Cumhuriyet University
- Investigators
- Arzu Koçkanat, Asst.Prof., Principal investigator, Cumhuriyet University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07846098
- Sponsor's protocol ID
- CumhuriyetU_ArzuKockanat_003
- Status last verified
- Sep 2026
- First submitted
- 1 Dec 2025
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Intraosseous Anesthesia and Inferior Alveolar Nerve Block for Primary Mandibular Molars: A Randomized Controlled Clinical Study
- ClinicalTrials.gov ID
- NCT07846098
- Acronym / sponsor ID
- CumhuriyetU_ArzuKockanat_003
- Conditions
- Pain, Dental Caries
- Keywords
- intraosseous anesthesia, inferior alveolar nerve block, primary molar teeth
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Cumhuriyet UniversityUniversity, hospital or other
- Study start
- 14 May 2026 (actual)
- Primary completion
- 20 Nov 2026 (estimated)
- Study completion
- 20 Dec 2026 (estimated)
- First posted
- 29 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the present study is to compare computerized intra-osseous injection system to the conventional inferior alveolar nerve block in primary mandibular teeth.
Detailed description
This study is designed as a randomized controlled clinical trial. A total of 60 primary mandibular molars from 30 pediatric patients who present for routine dental treatment at the Department of Pediatric Dentistry, Faculty of Dentistry, Sivas Cumhuriyet University, will be included. The study will consist of two sessions for each patient, with the type of anesthesia determined through simple randomization. In one session, traditional inferior alveolar nerve block anesthesia will be administered using a traditional syringe, and in the other session, intraosseous anesthesia will be performed using the computer-controlled SleeperOne5 device.
During anesthesia administration, pain levels will be assessed using the Visual Analog Scale (VAS), patient satisfaction will be evaluated with the Facial Image Scale (FIS), and behavior will be scored using the Modified Venham Scale. Additionally, heart rate, the volume of anesthetic solution used, and onset time of anesthesia will be recorded for both techniques. Postoperative complications will be assessed one day after the treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| inferior alveolar nerve block | Active comparator | Other: Inferior Alveolar Nerve BlockConventional inferior alvoelar nerve block anaesthesia will be given using a traditional metal syringe |
| intraosseous anaesthesia | Experimental | Other: intraosseous anaesthesiaComputerized intraosseous anesthesia administration using SleeperOne5 |
Who may qualify
- Ages
- 6 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Children aged 6 to 8 years
- Systemically healthy (American Society of Anesthesiologists [ASA] physical status I)
- Positive or definitely positive behavior (Frankl Behavior Rating Scale score 3 or 4)
- Bilateral (contralateral) mandibular primary molars with deep dentin caries requiring treatment
- Able to attend a second appointment
Key exclusion criteria (4 listed)
- Known allergy to local anesthetic solutions
- Use of analgesics within the last 24 hours
- Acute infection
- Gingivitis, oral fistula, abscess, or bone loss in the area where anesthesia will be administered
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 |
|---|---|---|
| Inferior Alveolar Nerve Blockinferior alveolar nerve block using Articaine 4% with 1/200000 Adrenaline and a traditional needle injection | Other | inferior alveolar nerve block |
| intraosseous anaesthesiaintraosseous anaesthesia using Articaine 4% with 1/200000 Adrenaline and a special intraosseous injection device | Other | intraosseous anaesthesia |
Primary outcome
Pain Intensity Measured by Visual Analog Scale (VAS)
Time frame: Immediately after anesthetic injection and during dental treatment (Day 1)
Pain intensity will be assessed using the Visual Analog Scale (VAS), a 10-cm horizontal line ranging from 0 (no pain) to 10 (worst possible pain). Scores range from 0 to 10, with higher scores indicating greater pain.
2 secondary outcomes
Heart Rate
Time frame: Immediately before injection (baseline), during injection, and immediately after injection (Day 1)
Dental Anxiety and Behavior Measured by Venham Clinical Anxiety Rating Scale
Time frame: Immediately after anesthetic injection and during dental treatment (Day 1)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2026.
- 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.
Arzu Koçkanat, Asst.Prof. principal investigator
Cumhuriyet 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 Inferior Alveolar Nerve Block and intraosseous anaesthesia in people with Pain and Dental Caries, run by Cumhuriyet 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 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 29 Sep 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?
This study is still under way. Results are not available in the source record yet.
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 Intensity Measured by Visual Analog Scale (VAS) (time frame: Immediately after anesthetic injection and during dental treatment (Day 1)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2026.