Different Local Anesthesia Techniques for Mandibular Primary Molar Pulpectomy (NCT07714915) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Different Local Anesthesia Techniques for Mandibular Primary Molar Pulpectomy
Turkey (Türkiye)38 participantsStarted 2026-08-12
Plain-language summary
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.
Who can participate
Age range
6 Years – 8 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 6 to 8 years.
* Requiring bilateral pulpectomy treatment of mandibular primary molars.
* Frankl Behavior Rating Scale score of 3 or 4.
* American Society of Anesthesiologists (ASA) Physical Status I.
* No known allergy to local anesthetic agents.
* No previous experience with dental local anesthesia.
* No signs of acute abscess or swelling in the treatment area.
* Parent or legal guardian able to provide written informed consent and child willing to participate.
Exclusion Criteria:
* ASA Physical Status II or higher.
* Known allergy or contraindication to local anesthetic agents.
* Frankl Behavior Rating Scale score of 1 or 2.
* Children receiving psychological or psychiatric treatment.
* Physical or intellectual disabilities that could interfere with study procedures.
* Previous experience with dental local anesthesia.
* Presence of acute abscess, cellulitis, or diffuse swelling in the treatment area.
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.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
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
Dental Anxiety
Timeframe: Baseline and immediately after treatment
2
Behavioral Pain During Local Anesthesia
Timeframe: Immediately after local anesthetic injection
Trial details
NCT IDNCT07714915
SponsorRecep Tayyip Erdogan University Training and Research Hospital