| 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
|
|
|
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
|
|
|
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. |