Clinical trial NCT06245161: Efficacy of Computer Controlled Intraosseous Anesthesia in Pediatric Dental Patients
Official title: Efficacy of Computer Controlled Intraosseous Anesthesia in Pediatric Dental Patients (Randomized Controlled Clinical Trial)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Irreversible Pulpitis
Tooth Extraction
Keywords: Intraosseous anesthesia
Computer-controlled injection
pain management
dental anesthesia
pediatric dentistry
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2024-02-07
Enrollment: 120
Sex: ALL
Minimum age (years): 5
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 120 children eligible for the study will be divided into: Group I (restorative group): includes 60 quadrants, each have at least one primary molar indicated for restorative treatment or vital pulp therapy. It will be subdivided into 4 subgroups, each consists of 15 quadrant (upper and lower) allocated to Intra-osseous Anesthesia by QuickSleeper5 for the test groups or to infiltration or IANB in the control group

Group II (extraction group): includes 60 primary molars indicated for extraction. It will be subdivided into 4 subgroups; according either maxillary or mandibular primary molar is indicated for extraction, using Intra-osseous Anesthesia by QuickSleeper5 for the test groups ,or infiltration or IANB in the control group
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Assessment of Pain Reaction objectively
timeFrame: 1- Preoperatively phase (baseline) 2- During LA administration. 3-During dental treatment: Rubber dam placement and tooth preparation Or tooth extraction
measure: Assessment of Pain Reaction subjectively
timeFrame: 1-Post injection phase (1- minute). 2- Post treatment phase (10 minutes)
measure: Child dental anxiety
timeFrame: 1-Preoperative phase (baseline) 2- During local anesthesia administration 3-During dental treatment (restorative or extraction)
Secondary outcomes:
measure: Local anesthesia effect
timeFrame: 30 minutes postoperatively
measure: Assessment of occurrence of adverse events
timeFrame: follow up 24 hour postoperatively
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Alexandria University- Faculty of Dentistry
state: Alexandroa
Study officials:
affiliation: Alexandria Univeristy
name: sara quritum
role: PRINCIPAL_INVESTIGATOR
References: