Pain and Anxiety During Vital Pulp Therapy Using Different Local Anesthesia Techniques in Children
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Pediatric, Anesthesia. Basic parameters: 8 years — 10 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Evaluation of the Effects of Different Local Anesthesia Techniques on Dental Anxiety and Pain During Vital Pulp Therapy
Overview
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.
Primary outcome measures
- Pain Response During Local Anesthesia Administration [Time frame: During local anesthesia administration]
Secondary outcome measures (8)
- Dental Anxiety Level Assessed by the Modified Child Dental Anxiety Scale-Faces Version (MCDASf) [Time frame: Baseline (before treatment) and immediately after completion of treatment]
- Immediate Emotional Status Assessed by the Facial Image Scale (FIS) [Time frame: Before anesthesia administration and after local anesthesia administration]
- Post-Treatment Pain Intensity Assessed by the Wong-Baker Faces Pain Rating Scale [Time frame: Immediately after completion of treatment]
- Heart Rate [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 [Time frame: 24 hours after treatment]
- Blood Pressure [Time frame: Baseline (before local anesthesia), immediately after local anesthesia administration, during pulp exposure, and immediately after completion of treatment]
- Peripheral Oxygen Saturation (SpO₂) [Time frame: Baseline (before local anesthesia), immediately after local anesthesia administration, during pulp exposure, and immediately after completion of treatment]
- Body Temperature [Time frame: Baseline (before local anesthesia), immediately after local anesthesia administration, during pulp exposure, and immediately after completion of treatment]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Other
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07748390 · 2026/319