Efficacy of Computer Controlled Intraosseous Anesthesia in Pediatric Dental Patients

Irreversible Pulpitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06245161
• Other study ID #: 0588-01/2023
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2023
• Est. completion date: May 2024

Study information

• Verified date: October 2023
• Source: Alexandria University
• Contact: sara Quritum, PhD
• Phone: +201020019396
• Email: sara.quritum[@]alexu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: May 2024
• Est. primary completion date: April 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Years to 9 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Irreversible Pulpitis
• Pulpitis
• Tooth Extraction

Intervention

Device:
• Quicksleeper5
intraosseous anesthesia for dental treatment
• conventional anesthesia
inferior alveolar nerve block for treating mandibular molars infiltration anesthesia for treating maxillary molars

Locations

Country	Name	City	State
Egypt	Alexandria University- Faculty of Dentistry	Alexandria	Alexandroa

Sponsors (1)

Lead Sponsor	Collaborator
Alexandria University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of Pain Reaction objectively	Pain response will be assessed using Face, Legs, Activity, Cry Consolability (FLACC) scale	1- Preoperatively phase (baseline) 2- During LA administration. 3-During dental treatment: Rubber dam placement and tooth preparation Or tooth extraction
Primary	Assessment of Pain Reaction subjectively	it will done by the child using Face version of Visual Analogue Scale.	1-Post injection phase (1- minute). 2- Post treatment phase (10 minutes)
Primary	Child dental anxiety	It will be assessed using VENHAM Clinical Anxiety Scale	1-Preoperative phase (baseline) 2- During local anesthesia administration 3-During dental treatment (restorative or extraction)
Secondary	Local anesthesia effect	efficacy of anesthesia (using efficacy scale by Sixou et al )	30 minutes postoperatively
Secondary	Assessment of occurrence of adverse events	the occurrence of self-inflicted injury, pain at injection site or trismus, or any adverse events.	follow up 24 hour postoperatively