Pain and Anxiety During Vital Pulp Therapy Using Different Local Anesthesia Techniques in Children (NCT07748390) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Pain and Anxiety During Vital Pulp Therapy Using Different Local Anesthesia Techniques in Children
120 participantsStarted 2026-08-01
Plain-language 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. 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.
Who can participate
Age range
8 Years – 10 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is testing different local anesthesia techniques in children — can you explain what those different techniques might involve, and whether any of them are already used in your practice for kids my child's age?
2Since this study is 'not yet recruiting,' how long might we realistically wait before my child could even participate, and is there a standard approach you'd recommend in the meantime for managing pain during vital pulp therapy?
3The trial is measuring pain response during the anesthesia injection itself — does that mean there's a possibility my child could experience more discomfort during this study than they would with a routine dental visit?
4This trial has no assigned phase, which often means it's more of a procedural or observational study — does that change how you'd assess the risks versus benefits for my child compared to a drug trial?
5Are there already established local anesthesia methods for children undergoing vital pulp therapy that have a strong safety record, and would it make more sense for my child to go with one of those rather than participating in a study comparing techniques?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Pain Response During Local Anesthesia Administration
Timeframe: During local anesthesia administration
Trial details
NCT IDNCT07748390
SponsorRecep Tayyip Erdogan University Training and Research Hospital