Pulpitis - IrreversibleNCT07634900
Comparison of the Efficacy of Inferior Alveolar Nerve Block and Digital Anesthesia in Pulpectomy of Mandibular Permanent Molars in Children
A study testing Inferior Alveolar Nerve Block in people with Pulpitis - Irreversible and Pulpitis - Reversible, run by Inonu University at 1 site in Turkey (Türkiye).
Trial summary
This study aims to compare the effectiveness of inferior alveolar nerve block (IANB) and computer-controlled digital anesthesia in achieving adequate anesthesia in pediatric patients presenting with acute dental pain and requiring emergency endodontic treatment of mandibular permanent molars. Read more about this study
- Who is it for?
- Ages 6 to 14 years
- Conditions the study is for
- Pulpitis - Irreversible, Pulpitis - Reversible
- What is being tested?
- Inferior Alveolar Nerve Block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2026to 20 Mar 2027
- 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 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged 6-14 years
- Patients presenting with acute dental pain
- Patients requiring emergency endodontic treatment in mandibular permanent molars
- Cooperative patients who allowed clinical procedures
- Patients whose parents/legal guardians provided informed consent
Who cannot join
- Patients with systemic diseases affecting pain perception
- Patients with known allergy to local anesthetic agents
- Patients who used analgesics within 12 hours before treatment
- Patients with non-restorable teeth
- Patients with a history of behavioral management problems preventing treatment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Merve Bilmez Selen, PhD contact
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Inonu University Faculty of Dentistry
Malatya, Malatya, 44280
nisanur müdüroğlu, 905434631893, nisanur.muduroglu@inonu.edu.tr
About this study
This study aims to compare the effectiveness of inferior alveolar nerve block (IANB) and computer-controlled digital anesthesia in achieving adequate anesthesia in pediatric patients presenting with acute dental pain and requiring emergency endodontic treatment of mandibular permanent molars. Achieving profound anesthesia in such cases can be challenging due to acute inflammation.
Participants will be randomly assigned to receive either conventional IANB or digital anesthesia. Pain perception during the procedure will be assessed using validated pain scales. In addition, physiological parameters including heart rate and blood pressure will be recorded to evaluate the stress response associated with each anesthesia technique. Anesthesia success will be determined based on the absence of pain during treatment and the need for supplemental anesthesia.
The findings of this study are expected to provide evidence-based guidance for selecting the most effective and comfortable anesthesia technique in pediatric dental patients.
Read the detailed description
Achieving effective local anesthesia in pediatric patients presenting with acute dental pain remains a significant clinical challenge, particularly in mandibular permanent molars requiring emergency endodontic treatment. The success of conventional inferior alveolar nerve block (IANB) may be reduced in the presence of acute inflammation, leading to inadequate pain control and increased patient anxiety.
Computer-controlled digital anesthesia systems have been introduced as an alternative technique that allows for a more controlled and consistent delivery of local anesthetic solution. This may improve both patient comfort and the success of anesthesia.
The aim of this randomized clinical study is to compare the effectiveness of inferior alveolar nerve block (IANB) and computer-controlled digital anesthesia in pediatric patients with acute dental pain requiring emergency endodontic treatment of mandibular permanent molars.
Participants will be randomly allocated into two groups: the IANB group and the digital anesthesia group. All procedures will be performed under standardized clinical conditions. Pain perception during anesthesia administration and treatment will be evaluated using validated pain assessment scales.
In addition to subjective pain evaluation, physiological parameters including heart rate and blood pressure will be recorded to assess the stress response associated with each anesthesia technique. Anesthesia success will be determined based on the absence of pain during treatment and the need for supplemental anesthesia.
The results of this study are expected to provide clinically relevant evidence regarding the most effective and comfortable anesthesia technique for pediatric patients, thereby improving treatment outcomes and patient experience.
- Conditions
- Pulpitis - Irreversible, Pulpitis - Reversible
- Being tested
- Computer-Controlled Digital Anesthesia, Inferior Alveolar Nerve Block
- Keywords
- Inferior alveolar nerve block, Digital anesthesia, Pediatric dentistry, Mandibular molar, Pain assessment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computer-Controlled Digital AnesthesiaProcedure or surgery
Participants requiring emergency endodontic treatment for mandibular permanent molars will receive conventional inferior alveolar nerve block anesthesia using a conventional dental syringe and 4% articaine hydrochloride with 1:100,000 epinephrine.
Inferior Alveolar Nerve BlockProcedure or surgery
Participants requiring emergency endodontic treatment for mandibular permanent molars will receive computer-controlled intraosseous digital anesthesia using the SleeperOne computer-controlled local anesthesia delivery system and 4% articaine hydrochloride with 1:100,000 epinephrine.
| Study group | Role | What they receive |
|---|---|---|
| Inferior Alveolar Nerve Block Group | Experimental | Participants receiving conventional inferior alveolar nerve block anesthesia for mandibular permanent molars requiring emergency endodontic treatment. Receives: Procedure: Inferior Alveolar Nerve Block |
| Digital Anesthesia Group | Experimental | Participants receiving computer-controlled digital anesthesia for mandibular permanent molars requiring emergency endodontic treatment. Receives: Procedure: Computer-Controlled Digital Anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anesthesia success during endodontic treatment
Anesthetic success will be defined as completion of endodontic treatment without the need for supplemental anesthesia. Pain during treatment will be assessed using the Visual Analog Scale (VAS; 0-10) and will be considered in the evaluation of anesthetic success. Higher VAS scores indicate greater pain perception and lower anesthetic success.
Measured: During the procedure
Secondary outcomes (1)
Heart rate changes
Heart rate will be recorded at predefined time points to evaluate physiological stress response during anesthesia administration and treatment.
Measured: Before the procedure, during anesthetic administration, during pulp chamber roof removal, during extirpation, and immediately after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2026
- Study start1 Apr 2026
- Primary completion1 Feb 2027 (estimated)
- Study completion20 Mar 2027 (estimated)
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 Pulpitis - IrreversibleStudies of the same condition, open and under way.
- More trials run by Inonu 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 will be randomly assigned to one of two parallel groups: inferior alveolar nerve block (IANB) or computer-controlled digital anesthesia.
- Masking
- None (open label)
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Inonu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nisanur Müdüroğlu, Inonu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07634900
- Sponsor's protocol ID
- 2025/8393
- Status last verified
- Jun 2026
- First submitted
- 21 Apr 2026
- Last updated
- 9 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gaudin A, Clouet R, Boeffard C, Laham A, Martin H, Amador Del Valle G, Enkel B, Prud'homme T. Comparing intraosseous computerized anaesthesia with inferior alveolar nerve block in the treatment of symptomatic irreversible pulpitis: A randomized controlled trial. Int Endod J. 2023 Aug;56(8):922-931. doi: 10.1111/iej.13935. Epub 2023 May 29.
PubMed 37209243
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Efficacy of Inferior Alveolar Nerve Block and Digital Anesthesia in Pulpectomy of Mandibular Permanent Molars in Children
- ClinicalTrials.gov ID
- NCT07634900
- Acronym / sponsor ID
- 2025/8393
- Conditions
- Pulpitis - Irreversible, Pulpitis - Reversible
- Keywords
- Inferior alveolar nerve block, Digital anesthesia, Pediatric dentistry, Mandibular molar, Pain assessment
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- Inonu UniversityUniversity, hospital or other
- Study start
- 1 Apr 2026 (actual)
- Primary completion
- 1 Feb 2027 (estimated)
- Study completion
- 20 Mar 2027 (estimated)
- First posted
- 9 Jun 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 study aims to compare the effectiveness of inferior alveolar nerve block (IANB) and computer-controlled digital anesthesia in achieving adequate anesthesia in pediatric patients presenting with acute dental pain and requiring emergency endodontic treatment of mandibular permanent molars. Achieving profound anesthesia in such cases can be challenging due to acute inflammation.
Participants will be randomly assigned to receive either conventional IANB or digital anesthesia. Pain perception during the procedure will be assessed using validated pain scales. In addition, physiological parameters including heart rate and blood pressure will be recorded to evaluate the stress response associated with each anesthesia technique. Anesthesia success will be determined based on the absence of pain during treatment and the need for supplemental anesthesia.
The findings of this study are expected to provide evidence-based guidance for selecting the most effective and comfortable anesthesia technique in pediatric dental patients.
Detailed description
Achieving effective local anesthesia in pediatric patients presenting with acute dental pain remains a significant clinical challenge, particularly in mandibular permanent molars requiring emergency endodontic treatment. The success of conventional inferior alveolar nerve block (IANB) may be reduced in the presence of acute inflammation, leading to inadequate pain control and increased patient anxiety.
Computer-controlled digital anesthesia systems have been introduced as an alternative technique that allows for a more controlled and consistent delivery of local anesthetic solution. This may improve both patient comfort and the success of anesthesia.
The aim of this randomized clinical study is to compare the effectiveness of inferior alveolar nerve block (IANB) and computer-controlled digital anesthesia in pediatric patients with acute dental pain requiring emergency endodontic treatment of mandibular permanent molars.
Participants will be randomly allocated into two groups: the IANB group and the digital anesthesia group. All procedures will be performed under standardized clinical conditions. Pain perception during anesthesia administration and treatment will be evaluated using validated pain assessment scales.
In addition to subjective pain evaluation, physiological parameters including heart rate and blood pressure will be recorded to assess the stress response associated with each anesthesia technique. Anesthesia success will be determined based on the absence of pain during treatment and the need for supplemental anesthesia.
The results of this study are expected to provide clinically relevant evidence regarding the most effective and comfortable anesthesia technique for pediatric patients, thereby improving treatment outcomes and patient experience.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to one of two parallel groups: inferior alveolar nerve block (IANB) or computer-controlled digital anesthesia.
| Arm | Type | Receives |
|---|---|---|
| Inferior Alveolar Nerve Block Group | Experimental | Procedure: Inferior Alveolar Nerve BlockParticipants receiving conventional inferior alveolar nerve block anesthesia for mandibular permanent molars requiring emergency endodontic treatment. |
| Digital Anesthesia Group | Experimental | Procedure: Computer-Controlled Digital AnesthesiaParticipants receiving computer-controlled digital anesthesia for mandibular permanent molars requiring emergency endodontic treatment. |
Who may qualify
- Ages
- 6 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Children aged 6-14 years
- Patients presenting with acute dental pain
- Patients requiring emergency endodontic treatment in mandibular permanent molars
- Cooperative patients who allowed clinical procedures
- Patients whose parents/legal guardians provided informed consent
Key exclusion criteria (5 listed)
- Patients with systemic diseases affecting pain perception
- Patients with known allergy to local anesthetic agents
- Patients who used analgesics within 12 hours before treatment
- Patients with non-restorable teeth
- Patients with a history of behavioral management problems preventing treatment
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 |
|---|---|---|
| Computer-Controlled Digital AnesthesiaParticipants requiring emergency endodontic treatment for mandibular permanent molars will receive conventional inferior alveolar nerve block anesthesia using a conventional dental syringe and 4% articaine hydrochloride with 1:100,000 epinephrine. | Procedure or surgery | Digital Anesthesia Group |
| Inferior Alveolar Nerve BlockParticipants requiring emergency endodontic treatment for mandibular permanent molars will receive computer-controlled intraosseous digital anesthesia using the SleeperOne computer-controlled local anesthesia delivery system and 4% articaine hydrochloride with 1:100,000 epinephrine. | Procedure or surgery | Inferior Alveolar Nerve Block Group |
Primary outcome
Anesthesia success during endodontic treatment
Time frame: During the procedure
Anesthetic success will be defined as completion of endodontic treatment without the need for supplemental anesthesia. Pain during treatment will be assessed using the Visual Analog Scale (VAS; 0-10) and will be considered in the evaluation of anesthetic success. Higher VAS scores indicate greater pain perception and lower anesthetic success.
1 secondary outcome
Heart rate changes
Time frame: Before the procedure, during anesthetic administration, during pulp chamber roof removal, during extirpation, and immediately after the procedure
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 9 Jun 2026.
- Results publication: PubMed 37209243Gaudin A, Clouet R, Boeffard C, Laham A, Martin H, Amador Del Valle G, Enkel B, Prud'homme T. Comparing intraosseous computerized anaesthesia with inferior alveolar nerve block in the treatment of symptomatic irreversible pulpitis: A randomized controlled trial. Int Endod J. 2023 Aug;56(8):922-931. doi: 10.1111/iej.13935. Epub 2023 May 29.
- 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.
Merve Bilmez Selen, PhD contact
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 in people with Pulpitis - Irreversible and Pulpitis - Reversible, run by Inonu 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 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Jun 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?
Contact Nisanur Müdüroğlu, DDS (905434631893, nsnr_mdr@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anesthesia success during endodontic treatment (time frame: During the procedure). 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 NCT07634900, 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 9 Jun 2026.