An interventional study of Computer-Controlled Local Anesthesia and Conventional Inferior Alveolar Nerve Block in Dental Anxiety, Pain and Pulpal Diseases, sponsored by Recep Tayyip Erdogan University Training and Research Hospital. Not yet recruiting at 1 site in Turkey (Türkiye). Open to participants aged 6 Years to 8 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-12.
Sponsored by Recep Tayyip Erdogan University Training and Research Hospital · Not applicable, Interventional, and Treatment
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.
10,054 studies on the registry are indexed under Pain; 1,649 are open to participants now.
This study's planned enrollment of 38 is below the median of 66 across 8,493 interventional studies indexed under Pain.
Browse Pain studies →Recep Tayyip Erdogan University Training and Research Hospital is the lead sponsor of 88 studies on the registry; 19 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Procedure: Conventional Inferior Alveolar Nerve Block · Drug: Articaine hydrochloride with epinephrine 1:100,000 · Device: Standard Dental Aspirating Syringe
Procedure: Computer-Controlled Local Anesthesia · Drug: Articaine hydrochloride with epinephrine 1:100,000 · Device: Computer-Controlled Local Anesthetic Delivery System
Computer-controlled delivery of local anesthetic for mandibular primary molar pulpectomy.
Conventional inferior alveolar nerve block administered with a standard dental syringe for mandibular primary molar pulpectomy.
A 4% articaine hydrochloride solution with epinephrine 1:100,000 was used as the local anesthetic solution in both study groups.
A computer-controlled local anesthetic delivery device was used to deliver the anesthetic solution at a constant, pre-programmed injection rate.
A conventional dental aspirating syringe was used for manual administration of the local anesthetic solution.
Dental Anxiety
Dental anxiety assessed using the Modified Child Dental Anxiety Scale-faces version (MCDASf). Higher scores indicate higher levels of dental anxiety.
Time frame: 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.
Time frame: Immediately after local anesthetic injection
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.
Time frame: 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.
Time frame: Baseline and immediately after treatment.
Heart Rate
Heart rate measured using a pulse oximeter.
Time frame: Baseline and during local anesthetic administration
Blood Pressure
Systolic and diastolic blood pressure measured with an automated monitor.
Time frame: Baseline, during local anesthetic administration, and immediately after treatment
Peripheral Oxygen Saturation (SpO₂)
Peripheral oxygen saturation measured using pulse oximetry.
Time frame: Baseline, during local anesthetic administration, and immediately after treatment
Body Temperature
Body temperature measured using a digital thermometer.
Time frame: Baseline, during local anesthetic administration, and immediately after treatment
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Aug 2026; primary completion for Aug 2026, 0 months later.
Of 3,731 non-industry interventional studies with no phase under Pain, half reached primary completion within 10 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 23. This study's planned 0 months is below that.
Counting every sponsor, half of 3,830 studies reached it within 10 months; a quarter within 4 and three quarters within 23.
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This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Recep Tayyip Erdogan University Training and Research Hospital