An observational study in Pediatric and Anesthesia, sponsored by Recep Tayyip Erdogan University Training and Research Hospital. Not yet recruiting. Open to participants aged 8 Years to 10 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-05.
Sponsored by Recep Tayyip Erdogan University Training and Research Hospital · Observational
This prospective observational study aims to evaluate the effects of different local anesthesia techniques on dental anxiety and pain in children undergoing vital pulp therapy of permanent mandibular first molars. Conventional inferior alveolar nerve block and two computer-controlled local anesthetic delivery (CCLAD) systems used in routine clinical practice will be compared. The choice of anesthesia technique will be based on the clinician's routine decision-making, and no additional intervention or modification of standard treatment will be performed for research purposes. Dental anxiety, pain, physiological parameters, and postoperative complications will be assessed using validated clinical scales and routine clinical measurements. The findings may help improve pain and anxiety management during pediatric dental treatment while supporting evidence-based selection of local anesthesia techniques.
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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The study population will consist of children aged 8-10 years who require vital pulp therapy of permanent mandibular first molars and attend the Department of Pediatric Dentistry at Recep Tayyip Erdoğan University Faculty of Dentistry. Eligible participants will be systemically healthy children with appropriate cognitive and communication abilities and acceptable cooperation levels according to the Frankl Behavior Rating Scale (scores 3 or 4). Participants will be evaluated according to the routine clinical care provided, and the effects of different local anesthesia techniques on dental anxiety, pain response, physiological parameters, and postoperative outcomes will be assessed.
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.
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.
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.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
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.
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.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants in this cohort receive conventional inferior alveolar nerve block anesthesia as part of routine clinical care before vital pulp therapy of permanent mandibular first molars. The anesthesia technique is selected by the treating clinician according to standard clinical practice. No additional intervention or modification of the anesthesia procedure is performed for study purposes. Pain, dental anxiety, physiological parameters, and postoperative outcomes are evaluated and recorded.
Participants in this cohort receive computer-controlled local anesthetic delivery using the QuickSleeper system as part of routine clinical care before vital pulp therapy of permanent mandibular first molars. The anesthesia technique is selected by the treating clinician according to standard clinical practice. No additional intervention or modification of the routine treatment protocol is performed for study purposes. Pain, dental anxiety, physiological parameters, and postoperative outcomes are evaluated and recorded.
Participants in this cohort receive computer-controlled local anesthetic delivery using the SOAN system as part of routine clinical care before vital pulp therapy of permanent mandibular first molars. The SOAN system allows controlled administration of local anesthetic solution with regulated flow and pressure during the injection procedure. The anesthesia technique is selected by the treating clinician according to standard clinical practice and clinical requirements. No additional intervention, modification of the routine treatment protocol, or procedure solely for research purposes is performed. Dental anxiety, pain responses, physiological parameters, and postoperative outcomes are evaluated and recorded during and after the routine dental treatment process.
Pain Response During Local Anesthesia Administration
Pain response during local anesthesia administration will be assessed using the Face, Legs, Activity, Cry, Consolability (FLACC) scale. The FLACC scale evaluates behavioral pain responses in children based on five domains: facial expression, leg movement, activity, crying, and consolability. Scores range from 0 to 10, with higher scores indicating greater pain intensity.
Time frame: During local anesthesia administration
Dental Anxiety Level Assessed by the Modified Child Dental Anxiety Scale-Faces Version (MCDASf)
Dental anxiety levels will be evaluated using the Modified Child Dental Anxiety Scale-Faces version (MCDASf). The scale includes eight dental situations rated on a five-point Likert scale ranging from 1 (relaxed/not anxious) to 5 (very anxious). Total scores range from 8 to 40, with higher scores indicating higher levels of dental anxiety.
Time frame: Baseline (before treatment) and immediately after completion of treatment
Immediate Emotional Status Assessed by the Facial Image Scale (FIS)
The Facial Image Scale (FIS) will be used to evaluate children's immediate emotional status and dental anxiety. The scale consists of five facial expressions ranging from very happy to very unhappy. Higher scores indicate increased anxiety levels.
Time frame: Before anesthesia administration and after local anesthesia administration
Post-Treatment Pain Intensity Assessed by the Wong-Baker Faces Pain Rating Scale
Pain intensity after completion of vital pulp therapy will be assessed using the Wong-Baker Faces Pain Rating Scale. The scale ranges from 0 (no pain) to 10 (worst possible pain), with higher scores indicating greater pain intensity.
Time frame: Immediately after completion of treatment
Heart Rate
Heart rate (beats per minute) measured before local anesthesia, immediately after local anesthesia administration, during pulp exposure, and immediately after completion of treatment.
Time frame: Baseline (before local anesthesia), immediately after local anesthesia administration, during pulp exposure, and immediately after completion of treatment
Postoperative Complications After Vital Pulp Therapy
Postoperative complications following vital pulp therapy will be assessed by contacting parents 24 hours after treatment. The presence or absence of postoperative symptoms will be recorded.
Time frame: 24 hours after treatment
Blood Pressure
Systolic and diastolic blood pressure (mmHg) measured before local anesthesia, immediately after local anesthesia administration, during pulp exposure, and immediately after completion of treatment.
Time frame: Baseline (before local anesthesia), immediately after local anesthesia administration, during pulp exposure, and immediately after completion of treatment
Peripheral Oxygen Saturation (SpO₂)
Peripheral oxygen saturation (%) measured before local anesthesia, immediately after local anesthesia administration, during pulp exposure, and immediately after completion of treatment.
Time frame: Baseline (before local anesthesia), immediately after local anesthesia administration, during pulp exposure, and immediately after completion of treatment
Body Temperature
Body temperature (°C) measured before local anesthesia, immediately after local anesthesia administration, during pulp exposure, and immediately after completion of treatment.
Time frame: Baseline (before local anesthesia), immediately after local anesthesia administration, during pulp exposure, and immediately after completion of treatment
No study locations are listed for this record.
Plan to share: Undecided
No publications or documents are linked to this record.
Start is estimated for Aug 2026; primary completion for Nov 2026, 3 months later.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jul 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