Evaluation of Postoperative Pain and the Antimicrobial Effect of Super Oxidized Water (Microcyn) and Chlorhexidine When Compared With Sodium Hypochlorite in Teeth With Asymptomatic Necrotic Pulps. A Randomized Clinical Trial (NRS)
Evaluation of Postoperative Pain and the Antimicrobial Effect of Super Oxidized Water (Microcyn) and Chlorhexidine When Compared With Sodium Hypochlorite in Teeth With Asymptomatic Necrotic Pulps A Randomized Clinical Trial
The objective of this study is to evaluate the postoperative pain and antimicrobial efficacy when using super-oxidized water (Microcyn) and 2% Chlorhexidine as irrigating solutions in comparison to 2.5% Sodium hypochlorite in teeth with asymptomatic necrotic pulps.
Study Overview
Status
Detailed Description
The objective of this study is to evaluate the postoperative pain and antimicrobial efficacy when using super-oxidized water (Microcyn) and 2% Chlorhexidine as irrigating solutions in comparison to 2.5% Sodium hypochlorite in teeth with asymptomatic necrotic pulps.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Paunceh S Soliman, PHD candidate
- Phone Number: 01026999750
- Email: paunceh.soliman@dentistry.cu.edu.eg
Study Locations
-
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Cairo Governorate
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Cairo, Cairo Governorate, Egypt, 11553
- faculty of Dentistry Cairo university
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Contact:
- Paunceh S Soliman, PHD candidate
- Phone Number: 01026999750
- Email: paunceh.soliman@dentistry.cu.edu.eg
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients in good physical health; American Society of Anesthesiologists (ASA) class I or II.
- Patients whose age ranges between 18 and 50 years.
- Male and female patients.
- Patients having a single canal-tooth with asymptomatic necrotic pulp.
- Patients who can understand the number rating scale.
- Patients who accept to participate in the trial and can sign the informed consent
Exclusion Criteria:
- Pregnant females.
- Patients with intraoral or extraoral swelling.
- Patients whose tooth is non-restorable.
- Teeth with open apices.
- Teeth with radiographic evidence of root resorption.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Group A
Each canal will receive 2ml of super-oxidized water (Microcyn) irrigating solution between each instrument size and the subsequent one. |
The difference in concentration of chlorine between NaOCl and super oxidized water such that the concentration of chlorine ions in NaOCl is much higher than that in super-oxidized water. However, considering the 90% reduction in biofilm thickness and 98% reduction in colony count of microorganisms by super-oxidized water as demonstrated |
|
Active Comparator: Group B
Each canal will receive 2ml of 2% chlorhexidine irrigating solution between each instrument size and the subsequent one. |
Chlorhexidine (CHX) has been indicated as an alternative irrigation agent in the preparation of the root canal system, due to its broad-spectrum antimicrobial capacity, dentin tubule disinfection, dentin adsorption, high substantivity, and low toxicity compared to NaOCl. The inability to dissolve organic tissues of the CHX provides controversial in the use of this irrigant, and due to this limitation, some authors do not indicate it as the main irrigation solution in endodontic treatment despite its utility as a final irrigation solution. |
|
Active Comparator: Group C
Each canal will receive 2ml of 2.5 % sodium hypochlorite irrigating solution between each instrument size and the subsequent one. |
Sodium hypochlorite (NaOCl) is the most common and has been widely used in endodontics for more than 70 years because of its ability to act as a solvent for organic matter and its efficient antimicrobial action, however, at high concentrations, it is likely to irritate periradicular tissues. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Postoperative pain intensity at 6 hours post-instrumentation
Time Frame: 6 hours post-instrumentation
|
A pain chart using numerical rating scale (NRS) will then be used to record the patients' pain level. The NRS (0-10 scale) consists of a line anchored by two extremes "No pain" and "the worst pain". Patients will be asked to choose the mark that represented their level of pain from 0 to 10. Pain level will be assigned as follow: 0: no pain, 1-3: mild pain, 4-6: moderate pain, 7-10: severe pain. |
6 hours post-instrumentation
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Paunceh samy
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
There is no plan to share individual participant data (IPD) with other researchers due to participant confidentiality and privacy considerations.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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