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CTRI Number  CTRI/2024/08/072666 [Registered on: 19/08/2024] Trial Registered Prospectively
Last Modified On: 17/08/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison of Pain Relief and Antibacterial Effectiveness of Nano Chitosan vs. Sodium Hypochlorite in Root Canal Treatments for Young Adults: A Randomized Controlled Trial 
Scientific Title of Study   Evaluation of Post Operative Pain and Antibacterial Effectiveness of 0.2% Nano Chitosan and 2% Sodium Hypochlorite Irrigating Solutions in Routine Endodontic Procedure Among Young Adults: A Randomized Controlled Trial  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Safiya Nikhat 
Designation  PG student 
Affiliation  KVG Dental college and hospital Sullia 
Address  Room no.6 Department of Conservative dentistry and endodontics KVG Dental College and Hospital Kurunjibhag Sullia Dakshina kannada Karnataka 574327 India

Dakshina Kannada
KARNATAKA
574327
India 
Phone  7019855510  
Fax    
Email  safiyanikhat99@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Krishnaprasada L 
Designation  Professor and Head of the Department 
Affiliation  KVG Dental college and hospital Sullia 
Address  Room no.6 Department of Conservative dentistry and endodontics KVG Dental College and Hospital Kurunjibhag Sullia Dakshina kannada Karnataka 574327 India

Dakshina Kannada
KARNATAKA
574327
India 
Phone  9448012084  
Fax    
Email  drkpdental@yahoo.co.in  
 
Details of Contact Person
Public Query
 
Name  Dr Krishnaprasada L 
Designation  Professor and Head of the Department 
Affiliation  KVG Dental college and hospital Sullia 
Address  Room no.6 Department of Conservative dentistry and endodontics KVG Dental College and Hospital Kurunjibhag Sullia Dakshina kannada Karnataka 574327 India

Dakshina Kannada
KARNATAKA
574327
India 
Phone  9448012084  
Fax    
Email  drkpdental@yahoo.co.in  
 
Source of Monetary or Material Support  
KVG Dental College and Hospital Kurunjibhag Sullia Dakshina kannada Karnataka 574327 India 
 
Primary Sponsor  
Name  Dr Safiya Nikhat 
Address  Room no.6 Department of Conservative dentistry and endodontics KVG Dental College and Hospital Kurunjibhag Sullia Dakshina kannada Karnataka 574327 India 
Type of Sponsor  Other [Self ] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Safiya Nikhat  KVG Dental college and Hospital Sullia  room no.6 Department of Conservative dentistry and endodontics KVG Dental College and Hospital Kurunjibhag Sullia Dakshina kannada Karnataka 574327  India
Dakshina Kannada
KARNATAKA 
07019855510

safiyanikhat99@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Instituitional ethics committee KVG dental college and hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K041||Necrosis of pulp,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  2.5% sodium hypochlorite  evaluation of post operative pain and effectiveness of 2.5% sodium hypochlorite irrigating solution 5ml of irrigation solution is used, it is used for irrigation of canal so injected into the canal........... only in first appointment it is used 
Intervention  Nanochitosan irrigating solution  Evaluation of post operative pain and effectiveness of 0.2% nanochitosan irrigating solution 5ml of irrigation solution is used, it is used for irrigation of canal so injected into the canal........... only in first appointment it is used 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  35.00 Year(s)
Gender  Both 
Details  Single rooted teeth which are indicated for root canal treatment 
 
ExclusionCriteria 
Details  1.Teeth associated with the intraoral sinus.
2.Teeth associated with the extraoral sinus.
3.Presence of soft tissue swelling or abscess in relation to involved teeth.
4.History of antibiotic exposure in the previous 2 months.
• Teeth with a wide or open apex
• Teeth with abnormal anatomy or calcified root canals
• A psychologically disturbed patient
• Teeth containing vital pulp tissue.
• Periodontally affected teeth.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To Evaluate Post-Operative Pain and Antibacterial Effectiveness of 0.2% Nanochitosan and 2% Sodium Hypochlorite Irrigating Solutions in Routine Endodontic Procedures Among Young Adults.


 
6, 12, 24, 48, 72Hours 
 
Secondary Outcome  
Outcome  TimePoints 
1.Quantitative assessment of bacterial growth in the root canals of included participants prior to irrigation.
2.Quantitative assessment of bacterial growth in the root canals of included participants after irrigation.
3.To compare the effectiveness of 0.2% nano-chitosan & 2% sodium hypochlorite irrigating solutions on the bacteria in root canals before & after irrigation.
4.To compare the antibacterial effectiveness of 0.2% nano-chitosan & 2% sodium hypochlorite irrigating solutions.
5.To evaluate postoperative pain after endodontic treatment.
 
6, 12, 24, 48,72Hours 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   01/01/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="2"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Endodontic irrigation is crucial in dentistry as it focuses on cleaning and disinfecting the root canal system. For initiation of pain, primary etiological factor is microorganisms, predominantly bacteria. The persistence of microorganisms inside root canal is most common reason for failure of endodontic therapy and post-operative pain. Effective irrigation removes debris and bacteria, aiding in successful root canal treatments and preventing complications such as infection or reinfections. For eradication of root canal microorganisms, irrigation is the most important step in root canal treatment. Understanding irrigation techniques and solutions enhances overall quality of endodontic procedures, contributing to improved patient outcomes. 1

Various root canal irrigation solutions are used for root canal irrigation. Sodium hypochlorite is the most commonly used irrigant solution because it has highest antimicrobial activity, ability to dissolve organic substances present in root canal, and is affordable. Even though it has high antibacterial activity, there are some limitations and disadvantages with such as high surface tension, which inhibits penetration of irrigants into the lateral canal and isthmus, etc. Use of sodium hypochlorite at high concentrations for a longer period of time can lead to changes in dentine collagen. To overcome the limitations of sodium hypochlorite, a newer irrigants with the higher antimicrobial activity will be sought. Many nanoparticles have been introduced for the disinfection of root canals as an antimicrobial agent.2,3

Nanotechnology is a science that deals with the development of new surface properties and the restructuring of materials on a nano-meter scale of less than 100nm. Nanotechnology has been used in a wide range of endodontic applications. Chitosan, a deacetylated derivative of chitin, has been widely used in the medical field. It occurs in various forms, like powder, capsules, films, scaffolds, hydrogels, and beads. Chitosan nanoparticles have antibacterial, antiviral, and antifungal effects. Chitosan nanoparticles have the properties of biocompatibility, biodegradability, bioadhesion, chelating activity, and low toxicity to human cells. Chitosan nanoparticles can be used for root canal irrigation, to eliminate biofilm from root canals, and for tissue regeneration using membrane barriers in periapical surgery.4,5.

Hence, this study aims to evaluate the postoperative pain and antibacterial effectiveness of 0.2% nano-chitosan and 2% sodium hypochlorite irrigating solutions in routine endodontic procedures among young adults.

 
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