PediatricNCT07748390
Pain and Anxiety During Vital Pulp Therapy Using Different Local Anesthesia Techniques in Children
An observational study of Pediatric and Anesthesia, run by Recep Tayyip Erdogan University Training and Research Hospital.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 8 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Pediatric, Anesthesia
- Type of treatment
- Injection or infusion
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2026to 30 Dec 2026
- Phase
- Observational
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 8 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: 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.
Who may be able to join
- Children aged 8-10 years.
- Children and parents/legal guardians who agree to participate in the study and provide informed consent.
- Patients requiring vital pulp therapy of a permanent mandibular first molar.
- Patients classified as Frankl Behavior Rating Scale score 3 or 4. Systemically healthy children (ASA I).
- Children with adequate cognitive and communication abilities to understand the study procedures and pain/anxiety assessment scales.
- Permanent mandibular first molars without clinical or radiographic signs of abscess, fistula, or periapical pathology.
Who cannot join
- Children with systemic diseases or medical conditions affecting dental treatment.
- Children classified as Frankl Behavior Rating Scale score 1 or 2.
- Patients with known allergy or hypersensitivity to local anesthetic agents (e.g., lidocaine, articaine).
- Teeth with acute dental infection signs, including abscess, cellulitis, or extensive infection.
- Teeth showing clinical or radiographic evidence of periapical pathology.
- Children unable to understand or complete pain and anxiety assessment scales due to cognitive, visual, hearing, or communication limitations.
- Patients who do not comply with the study procedures or withdraw consent.
About this study
Official title: Evaluation of the Effects of Different Local Anesthesia Techniques on Dental Anxiety and Pain During Vital Pulp Therapy
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.
- Conditions
- Pediatric, Anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Conventional Inferior Alveolar Nerve Block | 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. | |
| QuickSleeper Computer-Controlled Local Anesthesia | 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. | |
| Controlled Local Anesthetic Delivery System Group | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During local anesthesia administration
Secondary outcomes (8)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline (before local anesthesia), immediately after local anesthesia administration, during pulp exposure, and immediately after completion of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2026
- Study start1 Aug 2026 (estimated)
- Primary completion15 Nov 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PediatricStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 120 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
- NCT07748390
- Sponsor's protocol ID
- 2026/319
- Status last verified
- Jul 2026
- First submitted
- 28 Jul 2026
- Last updated
- 5 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided