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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
120
intraosseous anesthesia for dental treatment
inferior alveolar nerve block for treating mandibular molars infiltration anesthesia for treating maxillary molars
Alexandria University- Faculty of Dentistry
Alexandria, Alexandroa, Egypt
RECRUITINGAssessment of Pain Reaction objectively
Pain response will be assessed using Face, Legs, Activity, Cry Consolability (FLACC) scale
Time frame: 1- Preoperatively phase (baseline) 2- During LA administration. 3-During dental treatment: Rubber dam placement and tooth preparation Or tooth extraction
Assessment of Pain Reaction subjectively
it will done by the child using Face version of Visual Analogue Scale.
Time frame: 1-Post injection phase (1- minute). 2- Post treatment phase (10 minutes)
Child dental anxiety
It will be assessed using VENHAM Clinical Anxiety Scale
Time frame: 1-Preoperative phase (baseline) 2- During local anesthesia administration 3-During dental treatment (restorative or extraction)
Local anesthesia effect
efficacy of anesthesia (using efficacy scale by Sixou et al )
Time frame: 30 minutes postoperatively
Assessment of occurrence of adverse events
the occurrence of self-inflicted injury, pain at injection site or trismus, or any adverse events.
Time frame: follow up 24 hour postoperatively
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