Digital intraosseous versus manual intraligamentary anesthesia for filling lower permanent molars in children
Official title: Comparison of Digital Intraosseous and Manual Intraligamentary Anesthesia in Children: A Randomized Controlled Trial
Run by Izmir Katip Celebi University · NCT07524569 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 6 Years to 12 Years |
| Sex | All |
| Enrollment | 78 (estimated) |
| Sponsor | Izmir Katip Celebi University Academic / other |
| Locations | 1 site (Izmir, Cigli) |
| Status | Recruiting |
| Started | April 1, 2026 |
| Main results expected | October 2027 |
| Study ends | October 2027 |
| Registry record updated | November 4, 2026 |
| Trial ID | NCT07524569 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Frontal EEG Changes During Anesthesia in People With Obesity vs. Normal Weight
This study tests whether frontal brain activity patterns during anesthesia differ between adults with obesity and those of normal weight.
-
Remimazolam versus Midazolam for anesthesia induction in older adults
This observational study compares remimazolam and midazolam when inducing anesthesia in people aged 65 and older undergoing elective non-cardiac surgery to see which provides better stability and safety.
-
Dexmedetomidine vs magnesium with lidocaine for eye block during DCR surgery
This trial tests whether adding dexmedetomidine or magnesium sulfate to lidocaine for a preemptive peribulbar block can better manage blood pressure and heart rate in adults undergoing DCR surgery under general anesthesia.
-
Hyperangulated vs. Macintosh blades for obstetric intubation
This study tests whether a hyperangulated blade or a Macintosh-style blade helps obstetric patients get an endotracheal tube placement more safely during cesarean deliveries under general anesthesia.
-
Pain monitoring with ANI during rapid sequence induction
This study tests whether the Analgesia Nociception Index (ANI) can measure pain during rapid sequence induction in adults undergoing tracheal intubation.
-
Sphenopalatine ganglion block to improve the surgical field during endoscopic pituitary removal
This trial will try an ultrasound-guided sphenopalatine ganglion block with bupivacaine and dexamethasone alongside general anesthesia to see if it improves the surgeon's view and reduces postoperative pain for adults aged 21–60 having endoscopic trans-nasal pituitary surgery.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.