Ligament versus inferior alveolar nerve block anesthesia with an electronic syringe for children's primary tooth pulpectomy
Comparing the Effectiveness of the Intraligament Anesthesia Technique With the Inferior Alveolar Nerve Block Technique Using the Electronic Syringe in Children: A Random Clinical Study
This trial tests whether ligament anesthesia or an inferior alveolar nerve block (IANB), delivered with an electronic syringe, causes less pain for cooperative children aged 5–9 undergoing pulpectomy on primary teeth.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 6 Years to 10 Years |
| Sex | All |
| Sponsor | Tishreen University Academic / other |
| Locations | 1 site (Latakia, Latakia Governorate) |
| Trial ID | NCT07095946 on ClinicalTrials.gov |
What this trial studies
This randomized, within-subject clinical trial gives each child two pulpectomies on different primary teeth on separate visits, using an electronic (computer-controlled) syringe for one intraligament injection and an IANB for the other. The electronic syringe controls flow rate and provides auditory distraction, and pain response and anesthesia effectiveness will be recorded for each technique. Eligible participants are cooperative children without systemic disease or signs of irreversible pulpitis, treated at the Faculty of Pediatric Dentistry, Tishreen University. The design allows direct comparison of the two techniques in the same patient to reduce between-subject variability.
Who should consider this trial
Good fit: Cooperative children aged 5 to 9 who need pulpectomy on primary teeth, have no systemic health problems, and have no clinical signs of irreversible pulpitis or periodontal ligament inflammation are ideal candidates.
Not a fit: Children who are uncooperative, have spontaneous or nocturnal pain, signs of irreversible pulpitis, periodontal ligament inflammation, systemic health problems, or who are outside the eligible age range will not be eligible and are unlikely to benefit from this trial.
Why it matters
Potential benefit: If successful, the results could help dentists choose a technique that reduces injection pain and anxiety for children having pulpectomy on primary teeth.
How similar studies have performed: Previous studies of computer-controlled local anesthetic delivery and comparisons between intraligament and IANB in children have shown mixed but generally favorable results for reduced injection discomfort, so this trial builds on existing, not entirely novel, evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Cooperative children based on Frankl Behavior Rating Scale (Positive or Definitely Positive) * No clinical signs or symptoms indicating irreversible pulpitis * No periodontal ligament inflammation of the tooth to be treated * Children aged between 5 and 9 years * Children without systemic health problems Exclusion Criteria: * Children who are uncooperative based on Frankl Behavior Rating Scale (Negative or Definitely Negative) * Presence of spontaneous or nocturnal pain * Clinical signs and symptoms indicating irreversible pulpitis * Presence of periodontal ligament inflammation of the treated tooth * Child age older than 10 years or younger than 3 years * Children with systemic health problems
Where this trial is running
Latakia, Latakia Governorate
- Faculty of Pediatric Dentistry, Tishreen University — Latakia, Latakia Governorate, Syria (Recruiting)
Study contacts
- Study coordinator: Abdul Wahab Nourallah, Prof.Dr
- Email: abdulnourallah@tishreen.edu.sy
- Phone: +963933395751
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.