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CTRI Number  CTRI/2024/05/067702 [Registered on: 21/05/2024] Trial Registered Prospectively
Last Modified On: 19/05/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   In- Vitro 
Study Design  Other 
Public Title of Study   How Laser and Ultrasound Help Dental Cleaners Reach Deep into Teeth: A Comparative Study 
Scientific Title of Study   Comparative Evaluation Of The Penetration Of Two Irrigation Solution Into Dentinal Tubules Using Diode Laser And Ultrasonic Activation:A Confocal Laser Microscopy Study. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Palak Hirani 
Designation  PG Student 
Affiliation  Datta Meghe Institute of Higher Education and Research  
Address  103 Dept of Conservative Dentistry and Endodontics SPDC Builiding DMIHER Sawangi Meghe

Wardha
MAHARASHTRA
442201
India 
Phone  09179174182  
Fax    
Email  palakhirani13@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Manoj Chandak 
Designation  Dean and Professor 
Affiliation  Datta Meghe Institute of Higher Education and Research  
Address  103 Dept of Conservative Dentistry and Endodontics SPDC Builiding DMIHER Sawangi Meghe

Wardha
MAHARASHTRA
442201
India 
Phone  9822693276  
Fax    
Email  drmanojchandak@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Dr Manoj Chandak 
Designation  Dean and Professor 
Affiliation  Datta Meghe Institute of Higher Education and Research  
Address  103 Dept of Conservative Dentistry and Endodontics SPDC Builiding DMIHER Sawangi Meghe

Wardha
MAHARASHTRA
442201
India 
Phone  9822693276  
Fax    
Email  drmanojchandak@yahoo.com  
 
Source of Monetary or Material Support  
Datta Meghe Institute of Higher Education and research Sawangi Meghe Wardha 442201 
 
Primary Sponsor  
Name  Datta Meghe Institute of Higher Education and Research 
Address  Sawangi Meghe Wardha 442201 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
Nil  NA 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Palak Hirani  103 1st floor Dept of Conservative Dentistry and Endodontics SPDC Building DMIHER Campus  103 Dept of Conservative Dentistry and Endodontics SPDC Building DMIHER Campus
Wardha
MAHARASHTRA 
09179174182

palakhirani13@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee,Datta Meghe Institute of Higher Education and Research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  its a pre- clinical study revolving around depth of penetration of irrigants through laser and ultrasonic mode of activation evaluating through confocal microscope 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NA 
Comparator Agent  NIL  NA 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  Freshly Extracted single rooted permanent tooth with closed apex. 
 
ExclusionCriteria 
Details  teeth displaying caries, restorations, visible cracks, abnormal morphology, multiple root canals, prior root canal treatment, developmental anomalies, external or internal resorption, multiple roots, and calcified root canals.  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Penetration of Irrigant Solution via different activation techniques into Dentinal Tubules  Results will be assessed at the end of 9 months 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NA 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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   N/A 
Date of First Enrollment (India)   25/07/2024 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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  

Introduction

Endodontic therapy aims to eradicate pulpal and periapical diseases by removing bacteria from root canals. Despite thorough cleaning, smear layer obstructs canal disinfection. Root canal preparation and irrigation, particularly with sodium hypochlorite, are essential for debridement. However, conventional techniques may leave untouched areas, necessitating innovative solutions like superoxidized water and laser-activated irrigation for effective treatment.

Rationale

The effectiveness of root canal treatment is contingent upon the success of the irrigating solution and the mode used for its activation, which is directly manifested through its ability to penetrate dentinal tubules. Thus, the focus of this experimental in-vitro study is to find the most suitable irrigating solution and an effective activation technique for better penetration into dentinal tubules.

Objective: The study will comparatively evaluate the effect of diode laser and ultrasonic activation on dentinal tubule penetration of oxidized water and sodium hypochlorite

Materials and method- The approach comprises categorizing 60 recently extracted single-rooted teeth, possessing fully formed apical foramina and with intact occlusal morphology, into six primary groups according to distinct irrigation techniques. Additionally, each group will be subdivided into two subsets based on the application of two different irrigants, resulting in 10 teeth per subset. Decoronated specimens will be injected with a particular Irrigant and activated using different techniques. Dentinal tubule penetration of oxidized water by low-level laser therapy and ultrasonic will be evaluated and compared using confocal laser microscopy.

Expected result- Dentinal tubule penetration of oxidized water as an irrigant is more effective than that of sodium hypochlorite using low-level laser therapy. 
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