NCT06245161

Efficacy of Computer Controlled Intraosseous Anesthesia in Pediatric Dental Patients

Efficacy of Computer Controlled Intraosseous Anesthesia in Pediatric Dental Patients (Randomized Controlled Clinical Trial)

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Alexandria University · Academic / Other
• Sex: All
• Age: 5 Years – 9 Years
• Healthy volunteers: Accepted

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.

Conditions

• Irreversible Pulpitis
• Tooth Extraction

Interventions

Type	Name	Description
DEVICE	Quicksleeper5	intraosseous anesthesia for dental treatment
DEVICE	conventional anesthesia	inferior alveolar nerve block for treating mandibular molars infiltration anesthesia for treating maxillary molars

Timeline

• Start date: 2023-10-01
• Primary completion: 2024-04-01
• Completion: 2024-05-01
• First posted: 2024-02-07
• Last updated: 2024-02-07

Locations

1 site across 1 country: Egypt