COMPARATIVE EVALUATION OF CONVENTIONAL SYSTEM VS IONTOPHORESIS INFUSED IRRIGATING SYSTEM FOR PULPECTOMY IN PRIMARY TEETH - RCT
Overview
- Phase
- Phase 3
- Status
- Not yet recruiting
- Sponsor
- Rehan Modi
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- tests.
Overview
Brief Summary
A RCT will be conducted among 5-9 years of age in which there will be comparison done between conventional irrigating system and Iontophoresis infused irrigating system for dental procedures
Study will be done in 3 phases PHASE I Probe Design PHASE II Pilot Study PHASE III In-Vivo. Patients requiring bilateral Pulpectomy in mandibular molars, teeth with intact roots or more than 2/3rd of root present, patient who exhibits cooperative behaviour (Frankl Behaviour scale) will be included for the study and Children with special health care conditions, children who have taken antibiotic medication, teeth with excessive root resorption and mobility, patients who exhibit definitive negative behaviour, presence of dental abscess will be excluded
This study will be performed in patients visiting Department of Pediatric and
Preventive Dentistry, NPDCH, SPU Visnagar. 30 children will be included in the
study according to selection criteria.
- Ethical clearance for carrying out the study will be obtained prior from the
Institutional Ethics committee (IEC) before starting study. Study will be carried out
after written informed consent from each patient and parents.
- After clinical, Radiographic examination and based on inclusion criteria, patients
requiring bilateral pulpectomy will be selected.
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First irrigation system to be used will be decided by chit-pick method.
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After patient selection, LA administration and rubber dam isolation will be done.
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Caries excavation and access opening will be done conventionally using airoter and
burs.
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Pulp tissue will be extirpated.
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Canals will be irrigated by Normal Saline
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Irrigation will be done with Iontophoresis and Conventional needle
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1st sample (S1) will be collected from the canal with sterile paper points inserted up
to Working Length for 1 minute. For sample selection, distal canals will be selected
for Primary Mandibular molars. Multiple samples will be collected for culture test.
- Biomechanical preparation will be done by using one larger sequence files, up to
No-35 K-file: 2% taper (MANI, INC, JAPAN) in step back manner in the same visit
using randomized irrigation system.
- 2nd sample (S2) will be collected post instrumentation with same method.
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Candidate Signature Guide Signature
- Samples (S1 and S2) will be put in Nutrient Broth and sent to laboratory for cultural
analysis to count the growth of bacterial isolates. The Colony-Forming Unit (CFU)
counts from the pre-disinfection sample (S1) will serve as a baseline for comparing the
reduction in the CFU count post-irrigation (S2).
- Obturation will be done with Endoflas followed by crown.
Study Design
- Study Type
- Interventional
- Allocation
- Coin toss, Lottery, toss of dice, shuffling cards etc
- Masking
- Participant and Outcome Assessor Blinded
Eligibility Criteria
- Ages
- 5.00 Year(s) to 9.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Patient age between 5-9 years Patients requiring bilateral Pulpectomy in mandibular molars.
- •Teeth with intact roots or more than 2/3rd of root present.
- •Patient who exhibits cooperative behaviour (Frankl Behaviour scale).
Exclusion Criteria
- •Children with special health care conditions.
- •Children who have taken antibiotic medication.
- •Teeth with excessive root resorption and mobility.
- •Patients who exhibit definitive negative behaviour.
- •Presence of dental abscess.
Outcomes
Primary Outcomes
tests.
Time Frame: 6 months
To establish the microbiota in the root canal of primary teeth.
Time Frame: 6 months
To establish the anti-microbial efficacy of iontophoresis as irrigating system in reducing the microbial count of the primary teeth root canals using culture
Time Frame: 6 months
Secondary Outcomes
No secondary outcomes reported
Investigators
Dr Rehan Ahmed Modi
Narsinhbhai Patel Dental College and Hospital