- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03719261
Assessment of Pain and Antibacterial Activity of Chitosan Versus Sodium Hypochlorite as Irrigant in Infected Canal
October 23, 2018 updated by: sarah mahgoub, Cairo University
Assessment of Postoperative Pain and Antibacterial Activity of Chitosan Nanoparticles Versus Sodium Hypochlorite as a Root Canal Irrigant in Infected Root Canal
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Anticipated)
24
Phase
- Phase 2
- Phase 3
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: sodium hypochlorite
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
|
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
|
EXPERIMENTAL: chitosan nanoparticles
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
|
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
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
antibacterial activity
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
|
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).
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ANTICIPATED)
November 1, 2018
Primary Completion (ANTICIPATED)
April 1, 2019
Study Completion (ANTICIPATED)
October 1, 2019
Study Registration Dates
First Submitted
October 20, 2018
First Submitted That Met QC Criteria
October 23, 2018
First Posted (ACTUAL)
October 25, 2018
Study Record Updates
Last Update Posted (ACTUAL)
October 25, 2018
Last Update Submitted That Met QC Criteria
October 23, 2018
Last Verified
October 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Postoperative Complications
- Pain
- Neurologic Manifestations
- Pain, Postoperative
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antimetabolites
- Anticholesteremic Agents
- Hypolipidemic Agents
- Lipid Regulating Agents
- Hemostatics
- Coagulants
- Chelating Agents
- Sequestering Agents
- Disinfectants
- Chitosan
- Sodium Hypochlorite
- Eusol
Other Study ID Numbers
- Sarah mahgoub
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
there is no plan to make the individual participant data available to other researchers.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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