Back to resultsAssessment of Pain and Antibacterial Activity of Chitosan Versus Sodium Hypochlorite as Irrigant in Infected Canal
Primary Purpose
Postoperative Pain
Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
chitosan nanoparticles
Sodium Hypochlorite
Sponsored by
About this trial
This is an interventional treatment trial for Postoperative Pain
Eligibility Criteria
Inclusion Criteria:
- Young adult Patients, both genders, aging from 18-45 years.
- Patients with permanent mature teeth (closed apex).
- Single rooted single canal necrotic anterior teeth without apical periodontitis or with slight widening of peridontium.
- Patients should be free from any systemic disease.
- Patients with normal periodontal depth less or equal 3 mm.
- Patients who will agree to the consent and will commit to follow-up.
Exclusion Criteria:
- Patients with permanent immature teeth.
- Teeth with vital pulps.
- Patients with facial swelling or acute infection or pain on percussion
- Patients with fistula.
- Teeth with vertical root fractures, internal or external root resorption and calcification
- Teeth with periodontal involvement or periapical bone loss.
- Patients with any systemic disease that may affect predictable outcome.
- Pregnant or lactating females.
- Non-restorable teeth.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
sodium hypochlorite
chitosan nanoparticles
Arm Description
Sodium hypochlorite (NaOCL) is the most recommended irrigant due to its broad antibacterial effect, necrotic tissues and dentin collagen dissolving capability and inactivation of endotoxins.10ml of 2.5%NaOCL will be used during instrumentation in control group
Chitosan is a bioactive polymer obtained from deacetylation of chitin and is used in biomedical application due to its antimicrobial properties and biocompatibility and ability to resist aging for longer periods provide antibacterial effect in root canal disinfection.10ml of cs-np will be used during instrumentation in intervention group
Outcomes
Primary Outcome Measures
antibacterial activity
antibacterial activity will be evaluated by Sampling and culture method. The samples will be subjected to microbiological analysis to ascertain their individual microbiological load after 24h, this will be analyzed by counting the colony forming units (CFUs).
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03719261
Brief Title
Assessment of Pain and Antibacterial Activity of Chitosan Versus Sodium Hypochlorite as Irrigant in Infected Canal
Official Title
Assessment of Postoperative Pain and Antibacterial Activity of Chitosan Nanoparticles Versus Sodium Hypochlorite as a Root Canal Irrigant in Infected Root Canal
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Unknown status
Study Start Date
November 2018 (Anticipated)
Primary Completion Date
April 2019 (Anticipated)
Study Completion Date
October 2019 (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
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
A randomized clinical trial that aims to study the effect of chitosan nanoparticles (CS-np) versus sodium hypochlorite as a root canal irrigant on postoperative pain and antibacterial activity against E.faecalis in infected root canal.
Detailed Description
This trial aims to study the effect of chitosan nanoparticles (CS-np) versus sodium hypochlorite as a root canal irrigant on postoperative pain and antibacterial activity against E.faecalis in infected root canal. initial pre-treatment root canal sample will be taken.These will be designated as sample no.1. after first sample, according to random sequence, the patients will be randomly assigned into two groups. In Group I: Sodium hypochlorite (NaOCL 2.5%) will be used during instrumentation of the canals.In Group II: chitosan nanoparticles (CS-np) will be used. after preparation, the sample no.2 will be taken.Pain will be assessed by giving the patient the numerical pain rating scale (NRS) to assess his pain at 24, 48 and 72 hours after the first visit.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Masking Description
Double blinded The patient is also outcome assessor will be blinded as well as data analyst person.
Allocation
Randomized
Enrollment
24 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
sodium hypochlorite
Arm Type
Active Comparator
Arm Description
Sodium hypochlorite (NaOCL) is the most recommended irrigant due to its broad antibacterial effect, necrotic tissues and dentin collagen dissolving capability and inactivation of endotoxins.10ml of 2.5%NaOCL will be used during instrumentation in control group
Arm Title
chitosan nanoparticles
Arm Type
Experimental
Arm Description
Chitosan is a bioactive polymer obtained from deacetylation of chitin and is used in biomedical application due to its antimicrobial properties and biocompatibility and ability to resist aging for longer periods provide antibacterial effect in root canal disinfection.10ml of cs-np will be used during instrumentation in intervention group
Intervention Type
Drug
Intervention Name(s)
chitosan nanoparticles
Other Intervention Name(s)
chitosan
Intervention Description
Chitosan is a bioactive polymer obtained from deacetylation of chitin and is used in biomedical application due to its antimicrobial properties and biocompatibility and ability to resist aging for longer periods provide antibacterial effect in root canal disinfection.10ml of cs-np will be used during instrumentation in intervention group
Intervention Type
Drug
Intervention Name(s)
Sodium Hypochlorite
Intervention Description
Sodium hypochlorite (NaOCL) is the most recommended irrigant due to its broad antibacterial effect, necrotic tissues and dentin collagen dissolving capability and inactivation of endotoxins.10ml of 2.5%NaOCL will be used during instrumentation in control group
Primary Outcome Measure Information:
Title
antibacterial activity
Description
antibacterial activity will be evaluated by Sampling and culture method. The samples will be subjected to microbiological analysis to ascertain their individual microbiological load after 24h, this will be analyzed by counting the colony forming units (CFUs).
Time Frame
two samples will be taken at the same visit of endodontic treatment at day 1, the outcome measures will be assessed after 24h. the data will be reported after study compeletion about 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Young adult Patients, both genders, aging from 18-45 years.
Patients with permanent mature teeth (closed apex).
Single rooted single canal necrotic anterior teeth without apical periodontitis or with slight widening of peridontium.
Patients should be free from any systemic disease.
Patients with normal periodontal depth less or equal 3 mm.
Patients who will agree to the consent and will commit to follow-up.
Exclusion Criteria:
Patients with permanent immature teeth.
Teeth with vital pulps.
Patients with facial swelling or acute infection or pain on percussion
Patients with fistula.
Teeth with vertical root fractures, internal or external root resorption and calcification
Teeth with periodontal involvement or periapical bone loss.
Patients with any systemic disease that may affect predictable outcome.
Pregnant or lactating females.
Non-restorable teeth.
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
there is no plan to make the individual participant data available to other researchers.
Learn more about this trial
Assessment of Pain and Antibacterial Activity of Chitosan Versus Sodium Hypochlorite as Irrigant in Infected Canal
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