Efficacy of Computer Controlled Intraosseous Anesthesia in Pediatric Dental Patients
- Conditions
- Tooth ExtractionIrreversible Pulpitis
- Interventions
- Device: conventional anesthesiaDevice: Quicksleeper5
- Registration Number
- NCT06245161
- Lead Sponsor
- Alexandria University
- Brief Summary
To evaluate the effectiveness of intra-osseous anesthesia using Quicksleepr5 in pain elimination during dental treatment in maxillary and mandibular primary molars, compared to conventional anesthesia.
- Detailed Description
The study will be an eight-armed randomized controlled trial, parallel design. A total of 120 pediatric dental patients aged from 5 to 9 years with good health, will be selected from the Pediatric Dentistry and Dental Public Health Department clinic, Faculty of Dentistry, Alexandria University, Egypt. They will be recruited among those who need local anesthesia to perform either quadrant restorative treatment or extraction of their primary molars. Participants will be allocated into 2 groups according to the local anesthetic technique to be used. Children in the test group will receive intraosseous anesthesia using QuickSleeper5, while inferior alveolar nerve block or infiltration anesthesia will be used for those who are in the control group. All the procedures will be videotaped. Pain response upon needle prick and dental treatment will be assessed subjectively using the visual analogue scale, and objectively using Face, Leg, Activity, cry, Consolability scale. Physiological parameters will also be recorded to determine pain reaction. Efficacy, latency period and duration of anesthesia will be recorded for both injection techniques. Child behaviour toward dental treatment in both injection techniques will be evaluated using Frankl rating scale. Dental anxiety of pediatric patients will be evaluated from the videotapes using VENHAM Clinical Anxiety Scale. Postoperative assessment for the occurrence of any adverse events is planned.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 120
- Cooperative children during preoperative assessments.
- Patients selected in the restorative group: presenting with at least one primary molar indicated for restorative treatment or vital pulp therapy, after thorough clinical and radiographic examination.
- Patients selected in the extraction group: presenting with at least one primary molar indicated for extraction.
- Any physical or mental disability, or psychological problems.
- Immunocompromised patients.
- Hypersensitivity to local anesthetic drugs used
- History of previous dental local anesthesia.
- Taking analgesics or other medications that would alter the child behavior or awareness of pain 12- hours pre-operative
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description • Group IIB conventional anesthesia 15 maxillary primary molars indicated for extraction allocated to Infiltration anesthesia • Group IID conventional anesthesia 15 Mandibular primary molars indicated for extraction, allocated to inferior alveolar nerve block (IANB) anesthesia. • Group ID conventional anesthesia 15 mandibular quadrants each have at least one primary molar indicated for restorative treatment or vital pulp therapy, allocated to inferior alveolar nerve block (IANB) anesthesia • Group IIA Quicksleeper5 15 maxillary primary molars indicated for extraction allocated to Intra-osseous Anesthesia by QuickSleeper5 • Group IA Quicksleeper5 15 maxillary quadrants each have at least one primary molar indicated for restorative treatment or vital pulp therapy, allocated to Intra-osseous Anesthesia by QuickSleeper5. • Group IC Quicksleeper5 15 Mandibular quadrants each have at least one primary molar indicated for restorative treatment or vital pulp therapy, allocated to Intra-osseous Anesthesia by QuickSleeper5. • Group IIC Quicksleeper5 15 Mandibular primary molars indicated for extraction, allocated to Intra-osseous Anesthesia by QuickSleeper5 • Group IB conventional anesthesia 15 maxillary quadrants each have at least one primary molar indicated for restorative treatment or vital pulp therapy, allocated to infiltration anesthesia
- Primary Outcome Measures
Name Time Method Child dental anxiety 1-Preoperative phase (baseline) 2- During local anesthesia administration 3-During dental treatment (restorative or extraction) It will be assessed using VENHAM Clinical Anxiety Scale
Assessment of Pain Reaction objectively 1- Preoperatively phase (baseline) 2- During LA administration. 3-During dental treatment: Rubber dam placement and tooth preparation Or tooth extraction Pain response will be assessed using Face, Legs, Activity, Cry Consolability (FLACC) scale
Assessment of Pain Reaction subjectively 1-Post injection phase (1- minute). 2- Post treatment phase (10 minutes) it will done by the child using Face version of Visual Analogue Scale.
- Secondary Outcome Measures
Name Time Method Local anesthesia effect 30 minutes postoperatively efficacy of anesthesia (using efficacy scale by Sixou et al )
Assessment of occurrence of adverse events follow up 24 hour postoperatively the occurrence of self-inflicted injury, pain at injection site or trismus, or any adverse events.
Trial Locations
- Locations (1)
Alexandria University- Faculty of Dentistry
🇪🇬Alexandria, Alexandroa, Egypt