Pain, Dental Caries
Conditions
Keywords
intraosseous anesthesia, inferior alveolar nerve block, primary molar teeth
Brief summary
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.
Detailed description
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.
Interventions
inferior alveolar nerve block using Articaine 4% with 1/200000 Adrenaline and a traditional needle injection
OTHERintraosseous anaesthesia
intraosseous anaesthesia using Articaine 4% with 1/200000 Adrenaline and a special intraosseous injection device
Sponsors
Cumhuriyet University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Years to 8 Years
Healthy volunteers
Yes
Inclusion criteria
* Children aged 6 to 8 years * Systemically healthy (American Society of Anesthesiologists \[ASA\] physical status I) * Positive or definitely positive behavior (Frankl Behavior Rating Scale score 3 or 4) * Bilateral (contralateral) mandibular primary molars with deep dentin caries requiring treatment * Able to attend a second appointment * Written informed consent from a parent/legal guardian and assent from the child
Exclusion criteria
* Known allergy to local anesthetic solutions * Use of analgesics within the last 24 hours * Acute infection * Gingivitis, oral fistula, abscess, or bone loss in the area where anesthesia will be administered
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Intensity Measured by Visual Analog Scale (VAS) | Immediately after anesthetic injection and during dental treatment (Day 1) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Heart Rate | Immediately before injection (baseline), during injection, and immediately after injection (Day 1) | Heart rate will be measured in beats per minute (bpm) using a pulse oximeter. |
| Dental Anxiety and Behavior Measured by Venham Clinical Anxiety Rating Scale | Immediately after anesthetic injection and during dental treatment (Day 1) | 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. |
Countries
Turkey (Türkiye)
Contacts
PRINCIPAL_INVESTIGATORArzu Koçkanat, Asst.Prof.
Cumhuriyet University
Outcome results
None listed