Comparative evaluation of the effectiveness of straight elevator v/s twisted elevator in children during extraction of primary grossly decayed teeth and root stumps.
Trial Snapshot
- Phase
- Phase 3 4
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Extraction time
Study Overview
Brief Summary
This randomized controlled trial aims to evaluate and compare the effectiveness of a newly designed twisted elevator versus the conventional straight elevator in pediatric patients requiring extraction of grossly decayed primary teeth and root stumps. Eligible children will be randomly assigned to two groups: Group A (straight elevator) and Group B (twisted elevator). The study will assess extraction time, soft tissue trauma (modified Laskin criteria), intraoperative complications (root or bone fracture), postoperative pain and swelling, and physiological parameters (heart rate and oxygen saturation). It is hypothesized that the twisted elevator may reduce procedure time, tissue trauma, and postoperative discomfort, offering a safe and effective alternative to the conventional straight elevator in pediatric extractions.
Study Design
- Study Type
- Interventional
- Allocation
- Coin toss, Lottery, toss of dice, shuffling cards etc
- Masking
- Outcome Assessor Blinded
Eligibility Criteria
- Ages
- 4.00 Year(s) to 12.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Deciduous teeth indicated for extraction due to being grossly decayed or presenting as root stumps.
- •Tooth extractable using elevation/luxation technique without surgical sectioning.
- •ASA I or II physical status.
- •Cooperative behavior allowing extraction under local anesthesia.
- •Parental/guardian consent obtained; child assent where appropriate.
- •Available for postoperative follow-up (24 hours).
Exclusion Criteria
- •Children with special healthcare needs Frankl behavior rating 1 or 2 Pre-shedding mobility or pathological mobility of teeth Teeth with half root length Teeth with crown fracture extending sub-gingivally.
Outcomes
Primary Outcomes
Extraction time
Time Frame: Extraction time
Soft tissue trauma
Time Frame: Extraction time
Intra operative complications
Time Frame: Extraction time
Secondary Outcomes
- Post operative pain & swelling(Heart Rate)
Investigators
Kunal Audichya
Pacific dental college and hospital