Antibacterial Effect of Two Different Intracanal Medicaments and Their Effect on Post-operative Pain (Ca(OH)2 - CNPs)
Comparative Evaluation of Anti-Bacterial Efficacy Of Two Different Intracanal-Medicaments and Their Effect On Post-Operative Pain Level (A Randomized Clinical Trial)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Microorganisms within the root canal system exist as complex, multispecies biofilms made up of microcolonies that adhere permanently to each other and to surfaces such as dentin. The characteristics of these biofilms-including their composition, thickness, and location-vary according to environmental conditions like nutrient availability, pH, oxygen levels, and exposure to the oral cavity. Endodontic treatment aims to save teeth with damaged pulp tissue, as maintaining natural teeth is essential for proper oral function and overall health. Understanding the specific microorganisms involved in endodontic infections is crucial for explaining disease progression and selecting the most effective treatment strategies.
Because of the intricate anatomy of the root canal system, both mechanical instrumentation and chemical irrigation are required to reduce microbial load. However, chemo-mechanical debridement alone is often insufficient, allowing some bacteria to persist within the canal. As a result, antimicrobial intracanal medicaments have been introduced to enhance disinfection. Although several medicaments are currently used, many show limitations such as microbial resistance or an inability to simultaneously control intracanal infection and periapical inflammation. Additionally, antimicrobial agents may interact with the immune system, potentially suppressing or stimulating immune responses.
Enterococci, particularly *Enterococcus faecalis*, are frequently associated with persistent endodontic infections due to their resistance to treatment and ability to survive harsh conditions. Calcium hydroxide, a material introduced to dentistry in the early 20th century, is widely used as an intracanal medicament but has limited effectiveness against certain bacteria such as *E. faecalis*. Recent interest has focused on nanoparticles, which range from 1 to 100 nm in size and possess unique antimicrobial properties with reduced resistance. Among these, chitosan nanoparticles-derived from chitin found in crustacean exoskeletons-have gained attention for their biocompatibility and antibacterial effects. Effective intracanal medicaments are also important in reducing postoperative pain, which is commonly linked to bacterial irritation following endodontic treatment.
Study Type
Enrollment (Estimated)
Phase
- Phase 4
Contacts and Locations
Study Contact
- Name: Rana M Nagdy, MSc
- Phone Number: +201006224327
- Email: Rananagdy@dent.asu.edu.eg
Study Locations
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-
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Cairo, Egypt
- Faculty Of Dentistry Ain Shams University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- free medical history,
- mature infected permanent single rooted teeth diagnosed clinically and radiographically with adequate coronal structure for proper isolation, temporization and restoration.
Exclusion Criteria:
- Patients who are not included in the age range of the study or having a systemic condition.
- Teeth with severe fractures or resorption or periodontally compromised.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: control
|
|
|
Active Comparator: calcium hydroxide (Ca(OH)2)
intracanal medicament in infected root canal
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Non setting calcium hydroxide intracanal medicament is injected through the root canal for two weeks
|
|
Experimental: Chitosan nano particles (CNPs)
intracanal medication in infected root canal
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Nano chitosan gel is injected through the root canal as an intracanal medicament for two weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Bacterial load.
Time Frame: two weeks
|
Samples will be collected from the infected root canal before and after injection of intracanal medicaments then bacterial colonies will be counted for colony forming units per milliliter (CFU/ml) to assess the effect of the intracanal medicaments used.
|
two weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Visual Analogue Scale (VAS) to measure post operative pain level.
Time Frame: 12 hours, 24 hours, 48 hours, 72 hours.
|
the patient is given a 10 cm sheet to mark their pain level where (0) represents no pain and (10) the worst pain.
|
12 hours, 24 hours, 48 hours, 72 hours.
|
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
- FDASU-Rec IM012482
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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