Dental AnxietyNCT07714915
Different Local Anesthesia Techniques for Mandibular Primary Molar Pulpectomy
A study testing Conventional Inferior Alveolar Nerve Block, Articaine hydrochloride with epinephrine 1:100,000 and Standard Dental Aspirating Syringe in people with Dental Anxiety and Pain, run by Recep Tayyip Erdogan University Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
This study aims to compare the effects of computer-controlled local anesthesia and conventional inferior alveolar nerve block on dental anxiety and pain in children undergoing pulpectomy of mandibular primary molars. Read more about this study
- Who is it for?
- Ages 6 to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Anxiety, Pain, Pulpal Diseases
- What is being tested?
- Conventional Inferior Alveolar Nerve Block, Articaine hydrochloride with epinephrine 1:100,000 and Standard Dental Aspirating Syringe
- 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
- 38 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 12 Aug 2026to 15 Oct 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.
- Requiring bilateral pulpectomy treatment of mandibular primary molars.
- Frankl Behavior Rating Scale score of 3 or 4.
- American Society of Anesthesiologists (ASA) Physical Status I.
- No known allergy to local anesthetic agents.
- No previous experience with dental local anesthesia.
- No signs of acute abscess or swelling in the treatment area.
- Parent or legal guardian able to provide written informed consent and child willing to participate.
Who cannot join
- ASA Physical Status II or higher.
- Known allergy or contraindication to local anesthetic agents.
- Frankl Behavior Rating Scale score of 1 or 2.
- Children receiving psychological or psychiatric treatment.
- Physical or intellectual disabilities that could interfere with study procedures.
- Previous experience with dental local anesthesia.
- Presence of acute abscess, cellulitis, or diffuse swelling in the treatment area.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Recep Tayyip Erdoğan University
Merkez, Rize Province, 53020
dilara nil günaçar, 05412940104, dilaranil.tomrukcu@erdogan.edu.tr
About this study
Official title: Comparison of Computer-Controlled and Conventional Local Anesthesia Techniques on Dental Anxiety and Pain During Mandibular Primary Molar Pulpectomy: A Split-Mouth Randomized Clinical Trial
This study aims to compare the effects of computer-controlled local anesthesia and conventional inferior alveolar nerve block on dental anxiety and pain in children undergoing pulpectomy of mandibular primary molars. Both anesthesia techniques are routinely used in pediatric dental practice and are considered standard methods of care.
Children aged 6 to 8 years who require bilateral pulpectomy of mandibular primary molars will be included in this split-mouth randomized clinical trial. Each participant will receive both anesthesia techniques during separate treatment sessions. Dental anxiety, pain, and physiological parameters, including heart rate, blood pressure, oxygen saturation, and body temperature, will be assessed before, during, and after treatment using validated pediatric assessment scales and routine clinical measurements.
The findings of this study may help identify the anesthesia technique that provides greater comfort and reduces anxiety and pain during pediatric dental treatment, thereby improving the overall treatment experience for children.
- Conditions
- Dental Anxiety, Pain, Pulpal Diseases
- Being tested
- Computer-Controlled Local Anesthesia, Conventional Inferior Alveolar Nerve Block, Articaine hydrochloride with epinephrine 1:100,000, Computer-Controlled Local Anesthetic Delivery System, Standard Dental Aspirating Syringe
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computer-Controlled Local AnesthesiaProcedure or surgery
Computer-controlled delivery of local anesthetic for mandibular primary molar pulpectomy.
Conventional Inferior Alveolar Nerve BlockProcedure or surgery
Conventional inferior alveolar nerve block administered with a standard dental syringe for mandibular primary molar pulpectomy.
Articaine hydrochloride with epinephrine 1:100,000Drug
A 4% articaine hydrochloride solution with epinephrine 1:100,000 was used as the local anesthetic solution in both study groups.
Computer-Controlled Local Anesthetic Delivery SystemDevice
A computer-controlled local anesthetic delivery device was used to deliver the anesthetic solution at a constant, pre-programmed injection rate.
Standard Dental Aspirating SyringeDevice
A conventional dental aspirating syringe was used for manual administration of the local anesthetic solution.
| Study group | Role | What they receive |
|---|---|---|
| Conventional Inferior Alveolar Nerve Block | Active comparator | Not described Receives: Procedure: Conventional Inferior Alveolar Nerve Block; Drug: Articaine hydrochloride with epinephrine 1:100,000; Device: Standard Dental Aspirating Syringe |
| Computer-Controlled Local Anesthesia | Active comparator | Not described Receives: Procedure: Computer-Controlled Local Anesthesia; Drug: Articaine hydrochloride with epinephrine 1:100,000; Device: Computer-Controlled Local Anesthetic Delivery System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dental Anxiety
Dental anxiety assessed using the Modified Child Dental Anxiety Scale-faces version (MCDASf). Higher scores indicate higher levels of dental anxiety.
Measured: Baseline and immediately after treatment
Behavioral Pain During Local Anesthesia
Behavioral pain assessed using the Face, Legs, Activity, Cry, Consolability (FLACC) scale during local anesthesia administration. Scores range from 0 to 10, with higher scores indicating greater pain.
Measured: Immediately after local anesthetic injection
Secondary outcomes (6)
Self-reported Pain
Pain assessed using the Wong-Baker FACES Pain Rating Scale immediately after treatment. Self-reported pain assessed using the Wong-Baker FACES Pain Rating Scale (0-10) immediately after completion of pulpectomy. Scores range from 0 to 10, with higher scores indicating greater pain intensity.
Measured: Immediately after local anesthetic injection
Facial Image Scale (FIS) Score
Emotional status assessed using the Facial Image Scale (FIS). Higher scores indicate greater anxiety. Emotional status assessed using the Facial Image Scale (FIS). The scale ranges from 1 to 5, with 1 indicating no anxiety (very happy face) and 5 indicating severe anxiety (very unhappy face). Higher scores indicate greater anxiety.
Measured: Baseline and immediately after treatment.
Heart Rate
Heart rate measured using a pulse oximeter.
Measured: Baseline and during local anesthetic administration
Blood Pressure
Systolic and diastolic blood pressure measured with an automated monitor.
Measured: Baseline, during local anesthetic administration, and immediately after treatment
Peripheral Oxygen Saturation (SpO₂)
Peripheral oxygen saturation measured using pulse oximetry.
Measured: Baseline, during local anesthetic administration, and immediately after treatment
Body Temperature
Body temperature measured using a digital thermometer.
Measured: Baseline, during local anesthetic administration, and immediately after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2026
- Study start12 Aug 2026 (estimated)
- Primary completion15 Aug 2026 (estimated)
- Study completion15 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental AnxietyStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Recep Tayyip Erdogan University Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, DİLARA NİL GÜNAÇAR, Recep Tayyip Erdogan University Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07714915
- Sponsor's protocol ID
- 2026/268
- Status last verified
- Aug 2026
- First submitted
- 8 Jul 2026
- Last updated
- 12 Aug 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 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Computer-Controlled and Conventional Local Anesthesia Techniques on Dental Anxiety and Pain During Mandibular Primary Molar Pulpectomy: A Split-Mouth Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07714915
- Acronym / sponsor ID
- 2026/268
- Conditions
- Dental Anxiety, Pain, Pulpal Diseases
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- Recep Tayyip Erdogan University Training and Research HospitalUniversity, hospital or other
- Study start
- 12 Aug 2026 (estimated)
- Primary completion
- 15 Aug 2026 (estimated)
- Study completion
- 15 Oct 2026 (estimated)
- First posted
- 20 Jul 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 effects of computer-controlled local anesthesia and conventional inferior alveolar nerve block on dental anxiety and pain in children undergoing pulpectomy of mandibular primary molars. Both anesthesia techniques are routinely used in pediatric dental practice and are considered standard methods of care.
Children aged 6 to 8 years who require bilateral pulpectomy of mandibular primary molars will be included in this split-mouth randomized clinical trial. Each participant will receive both anesthesia techniques during separate treatment sessions. Dental anxiety, pain, and physiological parameters, including heart rate, blood pressure, oxygen saturation, and body temperature, will be assessed before, during, and after treatment using validated pediatric assessment scales and routine clinical measurements.
The findings of this study may help identify the anesthesia technique that provides greater comfort and reduces anxiety and pain during pediatric dental treatment, thereby improving the overall treatment experience for children.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional Inferior Alveolar Nerve Block | Active comparator | Procedure: Conventional Inferior Alveolar Nerve Block, Drug: Articaine hydrochloride with epinephrine 1:100,000, Device: Standard Dental Aspirating Syringe |
| Computer-Controlled Local Anesthesia | Active comparator | Procedure: Computer-Controlled Local Anesthesia, Drug: Articaine hydrochloride with epinephrine 1:100,000, Device: Computer-Controlled Local Anesthetic Delivery System |
Who may qualify
- Ages
- 6 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Children aged 6 to 8 years.
- Requiring bilateral pulpectomy treatment of mandibular primary molars.
- Frankl Behavior Rating Scale score of 3 or 4.
- American Society of Anesthesiologists (ASA) Physical Status I.
- No known allergy to local anesthetic agents.
Key exclusion criteria (7 listed)
- ASA Physical Status II or higher.
- Known allergy or contraindication to local anesthetic agents.
- Frankl Behavior Rating Scale score of 1 or 2.
- Children receiving psychological or psychiatric treatment.
- Physical or intellectual disabilities that could interfere with study procedures.
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 Local AnesthesiaComputer-controlled delivery of local anesthetic for mandibular primary molar pulpectomy. | Procedure or surgery | Computer-Controlled Local Anesthesia |
| Conventional Inferior Alveolar Nerve BlockConventional inferior alveolar nerve block administered with a standard dental syringe for mandibular primary molar pulpectomy. | Procedure or surgery | Conventional Inferior Alveolar Nerve Block |
| Articaine hydrochloride with epinephrine 1:100,000A 4% articaine hydrochloride solution with epinephrine 1:100,000 was used as the local anesthetic solution in both study groups. | Drug | Computer-Controlled Local Anesthesia, Conventional Inferior Alveolar Nerve Block |
| Computer-Controlled Local Anesthetic Delivery SystemA computer-controlled local anesthetic delivery device was used to deliver the anesthetic solution at a constant, pre-programmed injection rate. | Device | Computer-Controlled Local Anesthesia |
| Standard Dental Aspirating SyringeA conventional dental aspirating syringe was used for manual administration of the local anesthetic solution. | Device | Conventional Inferior Alveolar Nerve Block |
Primary outcome
Dental Anxiety
Time frame: Baseline and immediately after treatment
Dental anxiety assessed using the Modified Child Dental Anxiety Scale-faces version (MCDASf). Higher scores indicate higher levels of dental anxiety.
Behavioral Pain During Local Anesthesia
Time frame: Immediately after local anesthetic injection
Behavioral pain assessed using the Face, Legs, Activity, Cry, Consolability (FLACC) scale during local anesthesia administration. Scores range from 0 to 10, with higher scores indicating greater pain.
6 secondary outcomes
Self-reported Pain
Time frame: Immediately after local anesthetic injection
Facial Image Scale (FIS) Score
Time frame: Baseline and immediately after treatment.
Heart Rate
Time frame: Baseline and during local anesthetic administration
Blood Pressure
Time frame: Baseline, during local anesthetic administration, and immediately after treatment
Peripheral Oxygen Saturation (SpO₂)
Time frame: Baseline, during local anesthetic administration, and immediately after treatment
Body Temperature
Time frame: Baseline, during local anesthetic administration, and immediately after treatment
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 12 Aug 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional Inferior Alveolar Nerve Block, Articaine hydrochloride with epinephrine 1:100,000 and Standard Dental Aspirating Syringe in people with Dental Anxiety and Pain, run by Recep Tayyip Erdogan University Training and Research Hospital 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 7 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: opening soon, as of the sponsor's last update on 12 Aug 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 dilara nil günaçar (+905412940104, dilaranil.tomrukcu@erdogan.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dental Anxiety (time frame: Baseline and immediately after treatment). 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?
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 12 Aug 2026.