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Clinical Trials/CTRI/2025/07/091575
CTRI/2025/07/091575
Not yet recruiting
Phase 3

COMPARATIVE EVALUATION OF CONVENTIONAL SYSTEM VS IONTOPHORESIS INFUSED IRRIGATING SYSTEM FOR PULPECTOMY IN PRIMARY TEETH - RCT

Rehan Modi1 site in 1 country60 target enrollmentStarted: June 5, 2026Last updated:

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.

  1. 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.

  1. After clinical, Radiographic examination and based on inclusion criteria, patients

requiring bilateral pulpectomy will be selected.

  1. First irrigation system to be used will be decided by chit-pick method.

  2. After patient selection, LA administration and rubber dam isolation will be done.

  3. Caries excavation and access opening will be done conventionally using airoter and

burs.

  1. Pulp tissue will be extirpated.

  2. Canals will be irrigated by Normal Saline

  3. Irrigation will be done with Iontophoresis and Conventional needle

  4. 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.

  1. 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.

  1. 2nd sample (S2) will be collected post instrumentation with same method.

16

Candidate Signature Guide Signature

  1. 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).

  1. 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

Sponsor
Rehan Modi
Sponsor Class
Other [By Own]
Responsible Party
Principal Investigator
Principal Investigator

Dr Rehan Ahmed Modi

Narsinhbhai Patel Dental College and Hospital

Study Sites (1)

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