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Antimicrobial Efficacy of Four Different Irrigation Protocols

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ClinicalTrials.gov Identifier: NCT03668899
Recruitment Status : Not yet recruiting
First Posted : September 13, 2018
Last Update Posted : September 18, 2018
Sponsor:
Information provided by (Responsible Party):
maha nasr morsy abo shanab, Cairo University

Brief Summary:
proper disinfection of root canal system before obturation is a must for long term success of endodontic treatment, therefore a proper irrigant is mandatory, therefore investigators are studying the antibacterial effects of 4 different irrgating solutions in root canal treatment of patients diagnosed with necrotic pulps in their mandibular posterior teeth. patients will be recruited from outpatient clinic of the endodontic department in cairo university. endodontic treatment will be carried out as usual and samples from the infected root canals will be collected before and after preparation to be cultivated and analyzed at the laboratories of microbiology of faculty of medicine, cairo university

Condition or disease Intervention/treatment Phase
Dental Pulp Necrosis Procedure: irrigation Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Assessment of Antimicrobial Efficacy of Nano Chitosan, Chlorhexidine, Chlorhexidine/ Nano Chitosan Combination Versus Sodium Hypochlorite Irrigation in Patients With Necrotic Mandibular Posterior Teeth: A Randomized Clinical Trial
Estimated Study Start Date : January 2019
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : April 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics

Arm Intervention/treatment
Experimental: Chitosan NPs group
irrigation with Chitosan nanoparticles (final flush)
Procedure: irrigation
irrigation of root canals during mechanical preparation for pueposes of cleaning and disinfection

Experimental: Chlorhexidine group
irrigation with CHX (final flush)
Procedure: irrigation
irrigation of root canals during mechanical preparation for pueposes of cleaning and disinfection

Experimental: Combination group
irrigation with CHX/ nano Chitosan combination (final flush)
Procedure: irrigation
irrigation of root canals during mechanical preparation for pueposes of cleaning and disinfection

Active Comparator: Hypochlorite group
irrigation with NaOCL (final flush)
Procedure: irrigation
irrigation of root canals during mechanical preparation for pueposes of cleaning and disinfection




Primary Outcome Measures :
  1. number of colony forming units of bacteria [ Time Frame: 1 week after culture ]
    activity of the irrigating solution against bacteria in the root canal system, the less the number of colony forming units the better the irrigating solution is


Secondary Outcome Measures :
  1. visual analogue scale [ Time Frame: 1 week postoperatively ]
    pain incidence and intensity after root canal treatment The VAS consists of a10-cm line anchored by two extremes "No pain" and "pain as bad as could be"



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Patient's age between 18-50 years.
  2. Both male and female.
  3. Patient who are medically free and with good health
  4. Necrotic Mandibular posterior teeth

Exclusion Criteria:

  1. Pregnant females.
  2. Teeth with vital inflamed pulps, symptomatic periapical abscess and facial cellulitis, periodontally diseased and hopeless teeth.
  3. Teeth with previous fillings and/ or previous endodontic treatment

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Responsible Party: maha nasr morsy abo shanab, assistant lecturer of Endodontics, Cairo University
ClinicalTrials.gov Identifier: NCT03668899     History of Changes
Other Study ID Numbers: A
First Posted: September 13, 2018    Key Record Dates
Last Update Posted: September 18, 2018
Last Verified: September 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Chlorhexidine
Chlorhexidine gluconate
Necrosis
Dental Pulp Necrosis
Pathologic Processes
Dental Pulp Diseases
Tooth Diseases
Stomatognathic Diseases
Anti-Infective Agents
Anti-Bacterial Agents
Chitosan
Anti-Infective Agents, Local
Disinfectants
Dermatologic Agents
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Chelating Agents
Sequestering Agents
Hemostatics
Coagulants