An interventional study of Inferior Alveolar Nerve Block and intraosseous anaesthesia in Pain and Dental Caries, sponsored by Cumhuriyet University. Active, not recruiting at 1 site in Turkey (Türkiye). Open to participants aged 6 Years to 8 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-29.
Sponsored by Cumhuriyet University · Not applicable, Interventional, and Treatment
The aim of the present study is to compare computerized intra-osseous injection system to the conventional inferior alveolar nerve block in primary mandibular teeth.
This study is designed as a randomized controlled clinical trial. A total of 60 primary mandibular molars from 30 pediatric patients who present for routine dental treatment at the Department of Pediatric Dentistry, Faculty of Dentistry, Sivas Cumhuriyet University, will be included. The study will consist of two sessions for each patient, with the type of anesthesia determined through simple randomization. In one session, traditional inferior alveolar nerve block anesthesia will be administered using a traditional syringe, and in the other session, intraosseous anesthesia will be performed using the computer-controlled SleeperOne5 device.
During anesthesia administration, pain levels will be assessed using the Visual Analog Scale (VAS), patient satisfaction will be evaluated with the Facial Image Scale (FIS), and behavior will be scored using the Modified Venham Scale. Additionally, heart rate, the volume of anesthetic solution used, and onset time of anesthesia will be recorded for both techniques. Postoperative complications will be assessed one day after the treatment.
2,219 studies on the registry are indexed under Pain; 917 are open to participants now.
This study's planned enrollment of 30 is below the median of 70 across 1,904 interventional studies indexed under Pain.
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Exclusion Criteria:
Conventional inferior alvoelar nerve block anaesthesia will be given using a traditional metal syringe
Other: Inferior Alveolar Nerve Block
Computerized intraosseous anesthesia administration using SleeperOne5
Other: intraosseous anaesthesia
inferior alveolar nerve block using Articaine 4% with 1/200000 Adrenaline and a traditional needle injection
intraosseous anaesthesia using Articaine 4% with 1/200000 Adrenaline and a special intraosseous injection device
Pain Intensity Measured by Visual Analog Scale (VAS)
Pain intensity will be assessed using the Visual Analog Scale (VAS), a 10-cm horizontal line ranging from 0 (no pain) to 10 (worst possible pain). Scores range from 0 to 10, with higher scores indicating greater pain.
Time frame: Immediately after anesthetic injection and during dental treatment (Day 1)
Heart Rate
Heart rate will be measured in beats per minute (bpm) using a pulse oximeter.
Time frame: Immediately before injection (baseline), during injection, and immediately after injection (Day 1)
Dental Anxiety and Behavior Measured by Venham Clinical Anxiety Rating Scale
Anxiety and behavior will be evaluated using the Venham Clinical Anxiety Rating Scale. Scores range from 0 (relaxed, cooperative) to 5 (out of contact, no response to verbal commands), with higher scores indicating greater anxiety and less cooperative behavior.
Time frame: Immediately after anesthetic injection and during dental treatment (Day 1)
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is active, not recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Cumhuriyet University