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临床试验/CTRI/2025/07/091575
CTRI/2025/07/091575尚未招募3 期

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

Rehan Modi1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2026年6月5日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
60
试验地点
1
主要终点
tests.

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
5.00 Year(s) 至 9.00 Year(s)(—)
性别
All

入选标准

  • 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).

排除标准

  • 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.

结局指标

主要结局

tests.

时间窗: 6 months

To establish the microbiota in the root canal of primary teeth.

时间窗: 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

时间窗: 6 months

次要结局

未报告次要终点

研究者

发起方
Rehan Modi
申办方类型
Other [By Own]
责任方
Principal Investigator
主要研究者

Dr Rehan Ahmed Modi

Narsinhbhai Patel Dental College and Hospital

研究点 (1)

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