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CTRI Number  CTRI/2026/02/104790 [Registered on: 25/02/2026] Trial Registered Prospectively
Last Modified On: 08/04/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Other 
Public Title of Study   A study comparing different cleaning solutions during root canal treatment with and without laser use for better removal of germs from inside the teeth. 
Scientific Title of Study   A Comparative Evaluation of Irrigants with or without Diode Laser in Removal of Smear Layer Using File Systems: A SEM-EDX Study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  Other 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DR ANSHU SINGHANIA 
Designation  Postgraduate Student 
Affiliation  SARDAR PATEL POSTGRADUATE INSTITUTE OF DENTAL AND MEDICAL SCIENCES 
Address  Department of Pedodontics and Preventive Dentistry Department No. 5 Third Floor
Chaudhary Vihar
Lucknow
UTTAR PRADESH
226029
India 
Phone  08953415458  
Fax    
Email  anshusinghania76@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Anshul Sharma 
Designation  Professor 
Affiliation  SARDAR PATEL POSTGRADUATE INSTITUTE OF DENTAL AND MEDICAL SCIENCES 
Address  Department of Pedodontics and Preventive Dentistry Department No. 5 Third Floor
Chaudhary Vihar
Lucknow
UTTAR PRADESH
226029
India 
Phone  9415301634  
Fax    
Email  dranshulsharma84@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Anshul Sharma 
Designation  Professor 
Affiliation  SARDAR PATEL POSTGRADUATE INSTITUTE OF DENTAL AND MEDICAL SCIENCES 
Address  Department of Pedodontics and Preventive Dentistry Department No. 5 Third Floor
Chaudhary Vihar

UTTAR PRADESH
226029
India 
Phone  9415301634  
Fax    
Email  dranshulsharma84@gmail.com  
 
Source of Monetary or Material Support  
nil 
 
Primary Sponsor  
Name  Sardar Patel Postgraduate Instiitute of Dental and Medical Sciences 
Address  Room No 5 DEpartment of Pediatric and Preventive Dentistry 
Type of Sponsor  Private hospital/clinic 
 
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 Anshul Sharma  Sardar Patel Postgraduate Institute of Dental and Sciences  Department of Pedodontics and Preventive Dentistry Department No. 5 Third Floor
Lucknow
UTTAR PRADESH 
9415301634

dranshulsharma84@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee, Sppgidms, Lucknow  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K040||Pulpitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  HyFlex CM XP Endo File Systems Apple Cider Vinegar Chitosan  To evaluate the efficacy of Apple Cider Vinegar in smear layer removal using XP Endo File Systems. To evaluate the efficacy of Apple Cider Vinegar in adjunct with Diode LASER in smear layer removal using XP Endo File Systems. To evaluate the efficacy of 0.2% Chitosan in smear layer removal using XP Endo File Systems. To evaluate the efficacy of 0.2% Chitosan in adjunct with Diode LASER in smear layer removal using XP Endo File Systems. To evaluate the efficacy of Apple Cider Vinegar in smear layer removal using HyFlex CM File Systems. To evaluate the efficacy of Apple Cider Vinegar in adjunct with Diode LASER in smear layer removal using HyFlex CM File Systems. To evaluate the efficacy of 0.2% Chitosan in smear layer removal using HyFlex CM File Systems. To evaluate the efficacy of 0.2% Chitosan in adjunct with Diode LASER in smear layer removal using HyFlex CM File Systems. To compare the efficacy of Apple Cider Vinegar and 0.2% Chitosan in smear layer removal using XP Endo File Systems. To compare the efficacy of Apple Cider Vinegar and 0.2% Chitosan in adjunct with Diode LASER in smear layer removal using XP Endo File Systems. To compare the efficacy of Apple Cider Vinegar and 0.2% Chitosan in smear layer removal using HyFlex CM File Systems. To compare the efficacy of Apple Cider Vinegar and 0.2% Chitosan in adjunct with Diode LASER in smear layer removal using HyFlex CM File Systems.  
Comparator Agent  Sodium hypochlorite Normal Saline  17% EDTA and Sodium hypochlorite will serve as a positive control and Normal Saline (NS) as negative control. 
 
Inclusion Criteria  
Age From  11.00 Year(s)
Age To  14.00 Year(s)
Gender  Both 
Details  Extracted Premolar teeth with fully developed apices.
Recently extracted for orthodontic reasons.
Selected teeth had a length of given range 21-24 mm with intact crown and root.
Radiographs taken buccally and lingually to check the presence of single canal.
 
 
ExclusionCriteria 
Details  Tooth having grossly carious lesion.
Tooth having incomplete root formation.
Tooth showing presence of resorbed roots.
Tooth with any defect present on root surface.
Tooth with any curved roots and extremely calcified root canals.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Assess smear layer removal from dentinal surfaces at the coronal, middle, and apical thirds using Scanning Electron Microscopy (SEM) and Energy Dispersive x-ray (EDX).
 
Not Applicable 
 
Secondary Outcome  
Outcome  TimePoints 
Compare the performance of Apple Cider Vinegar, Chitosan, EDTA, & Normal Saline.
Evaluate the enhancement of smear layer removal with diode laser activation.
Compare XP Endo File & HyFlex CM File Systems in smear layer removal.
Assess the variation in smear layer removal across different root canal regions.
 
Not Applicable 
 
Target Sample Size   Total Sample Size="84"
Sample Size from India="84" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="90" 
Phase of Trial   N/A 
Date of First Enrollment (India)   10/03/2026 
Date of Study Completion (India) 15/09/2026 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Completed 
Recruitment Status of Trial (India)  Completed 
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  

The success of root canal treatment relies on the effective removal of dental pulp remnants, microorganisms, and microbial toxins through chemo-mechanical debridement. During preparation, debris accumulates on the wall of the root canal creating an amorphous layer called as smear layer. It is defined as “A layer of organic and inorganic material that is created on the surface of dentin during instrumentation of the root canal. This layer consists of dentin debris, pulp tissue remnants, and potential contaminants introduced during the procedure.” During root canal shaping and cleaning, irrigation acts as an effective method in the removal of micro-organisms, their by-products and the smear layer. Agents used in the removal of smear layer are phosphoric acid, citric acid, maleic acid, ethylenediaminetetraacetic acid (EDTA) and sodium hypochlorite (NaOCl).

 In root canal therapy, NaOCl solution is a widely used irrigant, responsible for its antimicrobial properties and capacity to dissolve organic tissues. Inadvertent extrusion of irrigant beyond the periapex, termed sodium hypochlorite accident, may also be the cause of endodontic flare ups. However, sodium hypochlorite is ineffective in dissolving the inorganic debris and eliminating the smear layer. Also, excessive dose can harm the periapical tissues.Various sophisticated irrigants such as Chitosan and herbal irrigants like Apple cider vinegar (ACV) along with irrigating file systems such as HyFlex CM File systems and recent XP Endo file have gained attention as potential alternatives to synthetic chemicals, primarily to mitigate the negative effects linked to synthetic irrigants.Chitosan is polysaccharide in nature obtained from the deacetylation of chitin from the seashell of crustaceans and shrimps. It possesses antibacterial effect and high

chelation ability which dissolves the inorganic parts of smear layers. Henceforth, considered as a final irrigation solution.Herbal irrigants such as Apple Cider Vinegar utilizes chemo-mechanical process to eliminate microorganisms, dissolve necrotic tissue, and remove the smear layer. It also offers the advantages of being a biocompatible and eco-friendly alternative to conventional irrigants.

 HyFlex CM NiTi file is an advanced endodontic instrument manufactured through a unique process i.e. Controlled Memory, ensuring extreme flexibility for superior canal tracking. It closely adapts to the canal anatomy, reducing the risk of ledging, transportation or perforation and can be pre-bent like stainless steel instruments. After heat treatment, they restore their form, providing up to 300% more fracture resistance. Newer XP Endo file is a continuous rotation file, effective in debris and smear layer removal as it facilitates irrigation which has ability in biofilm removal from the main canal as well as deep, narrow apical groove. Furthermore, Diode LASER is employed in root canal irrigation systems for its exceptional disinfection properties. After the preparation and rinsing of the root canal, it is used as an adjunct to conventional methods. With its ability to penetrate deep into dentinal tubules and target microorganisms in inaccessible areas, it also enhances disinfection and leads to better long-term prognosis.


 
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