Effectiveness of Intraosseus Injection Using Extra-short Needle Combined With Infiltration in Pediatric Patients With Molar Incisor Hypomineralization (A Randomized Controlled Clinical Trial)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Alexandria University
- Enrollment
- 26
- Locations
- 1
- Primary Endpoint
- Change in objective pain reaction
Study Overview
Brief Summary
Background: Effective pain control is crucial in managing pediatric dental patients. Molar-incisor hypomineralization (MIH), marked by enamel defects and dentin hypersensitivity, often hinders effective local anesthesia. Traditional injection methods may fall short, causing discomfort and complicating treatment. Combining infiltration with intraosseous injection using an extra-short 31-G needle may offer a more effective alternative.
Purpose: To compare the effectiveness of combined infiltration and intraosseous injection with an extra-short 31-G needle versus conventional techniques in eliminating pain during
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 6 Years to 9 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Healthy children, American Society of Anesthesiologists class I, II
- •Cooperative children during preoperative assessments according to the Frankl'
- •Behavioral Rating Scale (scores 3 or 4)
- •Patient presenting with at least one hypersensitive SCASS 2,3 [22] (Appendix III) deeply carious, MIH-affected FPM, with caries extending to the inner third of the dentin and close to the pulp, as shown in the periapical radiograph, consistent with TNI 4c classification for MIH
- •Written consent of the legal guardian.
Exclusion Criteria
- •Any physical or mental disability or psychological problems.
- •Immunocompromised patients.
- •Hypersensitivity to local anesthetic drugs used.
- •Taking analgesics or other medications that alter the child's behavior or awareness of pain 12- hours pre-operatively
- •Patients requiring emergency treatment.
- •FPM with preoperative signs and symptoms of clinical failure
Arms & Interventions
Intraosseous
Intervention: intraosseus anesthesia (Other)
Conventional nerve block
Intervention: Conventional nerve block (Other)
Outcomes
Primary Outcomes
Change in objective pain reaction
Time Frame: throughout the procedure
Pain response will be assessed using Face, Legs, Activity, Cry Consolability (FLACC) scale The scale has five criteria, each assigned a score of 0, 1 or 2 (zero means no pain and 2 means severe pain). The total score scale is scored in a range of 0-10 with 0 representing no pain
Change in subjective pain scores
Time Frame: throughout the procedure
It will be done by the child using Wong-Baker Faces Pain Rating Scale that ranged from 0 to 5. zero means no pain and 5 means pain is severe
Secondary Outcomes
- change in child anxiety(throughout the procedure)
- Local anesthesia efficacy(throughout the procedure)