Comparative Evaluation of Clinical Efficiency of Pediatric Single Rotary File Systems for Pulpectomy in Primary Molars – An In Vivo Study
Trial Snapshot
- Phase
- Phase 2/3
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- To evaluate the clinical efficiency of
Study Overview
Brief Summary
For themorphologically challenging primary root canals, pulpectomy serves as goldstandard therapeutic treatment. Manual hand files has various limitationssuch as time consuming and occurrence of iatrogenic errors. Rotary filesexclusively for primary tooth were introduced in India through KEDO Rotary files. Though the dual rotary file systems arehighly successful, the recently introduced single rotary file systems posses abetter features and quality than the former. Among the single rotary files, two different generations are introduced whose clinical efficiency has never been evaluated and we aim to find the better file among the Two generations of single rotary files
Study Design
- Study Type
- Interventional
- Allocation
- Permuted block randomization, fixed
- Masking
- Participant and Outcome Assessor Blinded
Eligibility Criteria
- Ages
- 4.00 Year(s) to 8.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •a)Normal, Healthy Children between 4 to 8 years b)Frankl’s Behaviour Rating 3 (positive), 4 (definitely positive) c)Primary molars with irreversible pulpitis d)Primary molars with no signs of pathological resorption e)IOPA Radiograph examination revealing primary molars with two thirds of each root remaining.
Exclusion Criteria
- •a)Primary molars with unrestorable crown structures.
- •b)Primary molars with perforated pulpal floor and sinus tract.
- •c)Primary molars with intraoral & extraoral swelling.
- •d)Primary molars with Grade III, IV mobility.
- •e)Children with special healthcare needs.
Outcomes
Primary Outcomes
To evaluate the clinical efficiency of
Time Frame: At Baseline
pediatric single rotary file systems by
Time Frame: At Baseline
assessing:
Time Frame: At Baseline
Obturation quality
Time Frame: At Baseline
Instrumentation time
Time Frame: At Baseline
Obturation time
Time Frame: At Baseline
Secondary Outcomes
- To compare patient discomfort levels in(children during the pulpectomy)