| 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
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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 |
|
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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 |
|
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Source of Monetary or Material Support
|
|
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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 |
|
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Details of Secondary Sponsor
|
|
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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 |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K040||Pulpitis, |
|
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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. |
|
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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.
|
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Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
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Blinding/Masking
|
Not Applicable |
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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 |
|
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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 |
|
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Target Sample Size
|
Total Sample Size="84" Sample Size from India="84"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="90" |
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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 |
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Publication Details
|
N/A |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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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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