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Antimicrobial Efficacy of Four Different Irrigation Protocols

Primary Purpose

Dental Pulp Necrosis

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
irrigation
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dental Pulp Necrosis

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Cairo University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Active Comparator

Arm Label

Chitosan NPs group

Chlorhexidine group

Combination group

Hypochlorite group

Arm Description

irrigation with Chitosan nanoparticles (final flush)

irrigation with CHX (final flush)

irrigation with CHX/ nano Chitosan combination (final flush)

irrigation with NaOCL (final flush)

Outcomes

Primary Outcome Measures

number of colony forming units of bacteria
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

visual analogue scale
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"

Full Information

First Posted
September 11, 2018
Last Updated
July 22, 2019
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT03668899
Brief Title
Antimicrobial Efficacy of Four Different Irrigation Protocols
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Unknown status
Study Start Date
August 2019 (Anticipated)
Primary Completion Date
January 2020 (Anticipated)
Study Completion Date
April 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

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

5. Study Description

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
Detailed Description
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 Introduction • Background Bacteria play a major role in the pathogenesis of apical periodontitis; therefore, success of endodontic treatment is dependent on its complete eradication before obturation1. It has been established that no instrumentation technique can sufficiently eradicate bacteria from the root canal system without proper irrigation. the success rate of endodontic treatment was claimed to be approximately 10-15% lower for teeth which yield a positive culture before obturation than for teeth which yield a negative culture1. A verity of irrigating solutions has been introduced and investigated for proper disinfection during endodontic treatment of which sodium hypochlorite (NaOCl) was considered the most popular of all available solutions for its superior antimicrobial effects and tissue dissolving abilities2. The inability of NaOCl to remove smear layer advocated the use of a chelating agent like EDTA or Citric acid for removal of smear layer after chemo-mechanical preparation3. Yet this wasn't the only downside to the use of NaOCl as the main irrigant, toxicity and irritation to the periapical tissues, burning of the surrounding oral tissues and the weakening effect on dentin flexural strength are also important disadvantages of NaOCl4,5. Chlorhexidine (CHX), is another popular irrigant which has a broad-spectrum antimicrobial activity plus substantivity, yet it has no tissue dissolving abilities of any kind6. Several studies compared the antimicrobial activity of NaOCl and CHX, some studies showed CHX to be superior to NaOCl7 other studies concluded that it had no added effect to those of NaOCl and that hypochlorite more often achieved negative cultures than CHX8 and several studies proved them both to be similarly effective9. A wide variety of natural solutions used for irrigation has emerged in order to overcome the downsides of NaOCl including Chitosan nanoparticles. Chitosan nanoparticles are known to have a good antimicrobial activity as well as a chelating effect which will allow for eradication of bacteria and removal of smear layer in the same time10. • Rationale A. The intervention benefits and databases search results Sodium hypochlorite (NaOCl); the gold standard for irrigation has many disadvantages including irritation of the periapical tissues and burning of surrounding tissues4,5. Therefore, the present study aims to explore new irrigating solutions probably more effective and less irritating to the periapical tissues than NaOCl. Recent studies have shed the light on a wide range of natural substances like Chitosan, Propolis, and other herbal solutions that are claimed to be as effective against bacteria as NaOCl and less toxic and less irritant4,and also introduced nanoparticles with their known antimicrobial capabilities as endodontic irrigants10,15. Besides its antimicrobial activity, Chitosan nanoparticles showed promising chelating abilities; Porchena et al suggested that CNPs irrigation was superior to NaOCl in that as well as inhibiting bacterial growth it also can remove the smear layer effectively10. An in vitro study in 2017 claimed that the combination of 2% Chlorhexidine and 2% Chitosan is as effective as NaOCl against E. Faecalis in biofilms5. B. The benefits of this study to the population and clinicians It is well established that the most probable cause failure of endodontic treatment is the presence of a persisting infection. Therefore, it is important that chemo-mechanical canal preparation be directed towards complete eradication of all bacteria from the root canal system so that the best possible prognosis can be achieved in endodontic treatment. Natural alternatives to sodium hypochlorite (NaOCl) can provide as efficient disinfection of the root canal system without the adverse effects of NaOCl on surrounding oral and periapical tissues. This may allow endodontists to perform an efficient and comfortable root canal treatments increasing the patients' confidence and creating a more positive attitude towards the dental profession. Objective of the present study The Aim of the current study is to compare the antimicrobial effects of Nano chitosan, Chlorhexidine and Chlorhexidine/ Nano Chitosan combination to sodium hypochlorite in patients with necrotic mandibular posterior teeth PICO Format P: population Patients diagnosed with necrotic mandibular posteriors. I: intervention I1: Irrigation with nano chitosan I2: Irrigation with chlorhexidine I3: Irrigation with Chlorhexidine/ nano Chitosan combination C: control Irrigation with sodium hypochlorite (NaOCl) O: outcome Primary Outcome Antibacterial efficacy: will be assessed by counting the number of colony forming units (CFU) after cultivating the collected samples before and after irrigation (S1 and S2) for each patient. Outcome Tool Unit Time antibacterial efficacy Number of CFUs Numerical data Samples collected before and after preparation and transferred to the laboratory for immediate cultivation. Secondary outcome Postoperative pain: will be recorded on a visual analogue scale (VAS), pain intensity will be recorded preoperatively and postoperatively after 6, 12, 24,48, 72 hours and 7 days. The VAS consists of a10-cm line anchored by two extremes "No pain" and "pain as bad as could be", patient will be asked to choose the mark that represent their level of pain. Pain level will be assigned to one of 4 categorical scores: 1, None (0); 2, Mild (1-3); 3, Moderate (4-6); 4, Severe (7-10). Outcome Tool Unit Time Postoperative pain Visual analogue scale VAS Categorial data Immediately after treatment and Up to 7 days after endodontic treatment Research Question: In necrotic mandibular posterior teeth, would irrigating the canals using either nano chitosan, chlorhexidine or a combination of nano chitosan and chlorhexidine versus sodium hypochlorite result in better canal disinfection and less postoperative pain?

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Pulp Necrosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Chitosan NPs group
Arm Type
Experimental
Arm Description
irrigation with Chitosan nanoparticles (final flush)
Arm Title
Chlorhexidine group
Arm Type
Experimental
Arm Description
irrigation with CHX (final flush)
Arm Title
Combination group
Arm Type
Experimental
Arm Description
irrigation with CHX/ nano Chitosan combination (final flush)
Arm Title
Hypochlorite group
Arm Type
Active Comparator
Arm Description
irrigation with NaOCL (final flush)
Intervention Type
Procedure
Intervention Name(s)
irrigation
Intervention Description
irrigation of root canals during mechanical preparation for pueposes of cleaning and disinfection
Primary Outcome Measure Information:
Title
number of colony forming units of bacteria
Description
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
Time Frame
1 week after culture
Secondary Outcome Measure Information:
Title
visual analogue scale
Description
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"
Time Frame
1 week postoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patient's age between 18-50 years. Both male and female. Patient who are medically free and with good health Necrotic Mandibular posterior teeth Exclusion Criteria: Pregnant females. Teeth with vital inflamed pulps, symptomatic periapical abscess and facial cellulitis, periodontally diseased and hopeless teeth. Teeth with previous fillings and/ or previous endodontic treatment
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Maha Nasr, master
Phone
01114367063
Email
Mahmouhaa87@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maha Nasr, Masters
Organizational Affiliation
studying for PhD in Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cairo University
City
Cairo
Country
Egypt

12. IPD Sharing Statement

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Antimicrobial Efficacy of Four Different Irrigation Protocols

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