Digital intraosseous versus manual intraligamentary anesthesia for filling lower permanent molars in children
Comparison of Digital Intraosseous and Manual Intraligamentary Anesthesia in Children: A Randomized Controlled Trial
This study tests whether digital intraosseous or manual intraligamentary injections cause less pain for children aged 6–12 who need fillings in lower permanent molars.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 78 (estimated) |
| Ages | 6 Years to 12 Years |
| Sex | All |
| Sponsor | Izmir Katip Celebi University Academic / other |
| Locations | 1 site (Izmir, Cigli) |
| Trial ID | NCT07524569 on ClinicalTrials.gov |
What this trial studies
This randomized, controlled, crossover, single-blind split-mouth study will enroll 78 children with similar bilateral enamel-dentin caries on the first permanent mandibular molars. Each child will receive both techniques—one on each side—with a one-week washout and randomized sequence assignment into two equal groups. Pain during injection and during the restorative procedure will be measured using the Visual Analog Scale and Wong-Baker FACES, while heart rate and oxygen saturation will be recorded. Anesthetic success, postoperative complications, and patient preference will be compared between the two techniques.
Who should consider this trial
Good fit: Children aged 6–12 years with ASA I, positive behavior (Frankl III–IV), good oral hygiene, and similar restorative needs on both first permanent mandibular molars are ideal candidates.
Not a fit: Children with allergies to local anesthetics or sulfites, cholinesterase deficiency, current use of pain-affecting drugs, need for sedatives during procedures, or without bilateral comparable lesions are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the preferred technique could reduce injection and procedure pain and improve comfort and cooperation during pediatric dental restorations.
How similar studies have performed: Related studies of intraosseous and intraligamentary techniques in adults and children have reported mixed results, with some intraosseous devices showing reduced injection pain, but direct pediatric split-mouth comparisons remain limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Subjects with American Society of Anesthesiologists score I (ASA I) * Subjects with Frankl's behavior rate III (positive) and IV (definitely positive), * Subjects with indication of similar restoration treatment on bilateral first -permanent mandibular molars * Subjects whose plaque index score of 0 (no plaque) and 1 * Subjects whose gingival index score of 0 Exclusion Criteria: * Allergic to the local anesthetics or sulfites * Subjects with cholinesterase deficiency * Subjects who use drugs that may affect the assessment of pain, such as narcotic or non-narcotic analgesic, anti-inflammatory, anxiolytic, antipsychotic and antihistamine agents * Subjects who need to use sedatives or other medications during dental procedures
Where this trial is running
Izmir, Cigli
- Izmir Katip Çelebi University Faculty of Dentistry — Izmir, Cigli, Turkey (Türkiye) (Recruiting)
Study contacts
- Study coordinator: Funda Çağırır Dindaroğlu, Study Director
- Email: fundacagirir@gmail.com
- Phone: +905363465653
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.