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CTRI Number  CTRI/2024/02/063023 [Registered on: 22/02/2024] Trial Registered Prospectively
Last Modified On: 06/06/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison of number of root canal openings and ease of detection using three different methods in primary molars 
Scientific Title of Study   To compare the Detection Rate And Ease Of Locating Root Canal Orifice in Primary Molars Using Surgical Loupes, Fluorescein Sodium Dye And Methylene Blue Dye: An In-Vivo 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  Dr Vaibhavi Vijay Pharne 
Designation  PG student 
Affiliation  Jawahar Medical Foundation Annasaheb Chudaman Patil Memorial Dental College 
Address  Department of Pedodontics Room no 5 Second floor Jawahar Medical Foundation Annasaheb Chudaman Patil Memorial Dental College Dhule

Dhule
MAHARASHTRA
424001
India 
Phone  8329697730  
Fax    
Email  vaibhavipharne@yahoo.in  
 
Details of Contact Person
Scientific Query
 
Name  Dr Aruna Vishwakarma 
Designation  Reader 
Affiliation  Jawahar Medical Foundation Annasaheb Chudaman Patil Memorial Dental College 
Address  Department of Pedodontics Room no 5 Second floor Jawahar Medical Foundation Annasaheb Chudaman Patil Memorial Dental College Dhule

Dhule
MAHARASHTRA
424001
India 
Phone  7875268077  
Fax    
Email  draruna_vk@yahoo.in  
 
Details of Contact Person
Public Query
 
Name  Dr Vaibhavi Pharne 
Designation  PG student 
Affiliation  Jawahar Medical Foundation Annasaheb Chudaman Patil Memorial Dental College  
Address  Department of Pedodontics Room no 5 Second floor Jawahar Medical Foundation Annasaheb Chudaman Patil Memorial Dental College Dhule

Dhule
MAHARASHTRA
424001
India 
Phone  8329697730  
Fax    
Email  vaibhavipharne@yahoo.in  
 
Source of Monetary or Material Support  
Jawahar Medical Foundation Annasaheb Chudaman Patil Memorial Dental College  
 
Primary Sponsor  
Name  Dr Vaibhavi Pharne 
Address  Department of Pedodontics Room no 5 Second floor Jawahar Medical Foundation Annasaheb Chudaman Patil Memorial Dental College Dhule 
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 Vaibhavi Pharne  Jawahar Medical Foundation Annasaheb Chudaman Patil Memorial Dental College  Department of Pedodontics Room no 5 Second floor Jawahar Medical Foundation Annasaheb Chudaman Patil Memorial Dental College Dhule
Dhule
MAHARASHTRA 
8329697730

vaibhavipharne@yahoo.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Jawahar Medical Foundation Annasaheb Chudaman Patil Memorial Dental College Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: Z001||Encounter for newborn, infant andchild health examinations,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Canal detector Methylene blue   2-3 drops(0.2 ml) after access opening to locate canals 
Intervention  Fluoro Touch Sterile strips  2-3 drops (0.2 ml) after access opening to locate canals 
 
Inclusion Criteria  
Age From  5.00 Year(s)
Age To  10.00 Year(s)
Gender  Both 
Details  Patients with caries in primary molars involving pulp
Primary molars with atleast two third of root present
Patients with no systemic disease
 
 
ExclusionCriteria 
Details  Patient with any systemic disease
Patient with more than two third root resorption in primary molars
Non restorable primary molars
Uncooperative patient 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Alternation 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To compare the detection rate and ease of detection of root canal orifices of primary
molar using surgical loupes, canal detector dye (methylene blue) and fluorescein sodium.
 
At the time of start of treatment 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate detection rate and ease of detection of root canal orifices of primary molar using surgical loupes
To evaluate detection rate and ease of detection of root canal orifices of primary molar using canal detector dye (methylene blue)
To evaluate detection rate and ease of detection of root canal orifices of primary molar using fluorescein sodium.
 
At the time of start of treatment 
 
Target Sample Size   Total Sample Size="38"
Sample Size from India="38" 
Final Enrollment numbers achieved (Total)= "38"
Final Enrollment numbers achieved (India)="38" 
Phase of Trial   N/A 
Date of First Enrollment (India)   02/03/2024 
Date of Study Completion (India) 04/06/2024 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 04/06/2024 
Estimated Duration of Trial   Years="0"
Months="3"
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [vaibhavipharne@yahoo.in].

  6. For how long will this data be available start date provided 29-05-2024 and end date provided 30-05-2025?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

 Introduction-

The major goal of root canal treatment is the thorough mechanical and chemical debridement of all root canals and their complete obturation with an inert filling material and a coronal filling preventing ingress of microorganisms. One of the main reasons for the failure of root canal therapy is the lack of sufficient knowledge concerning the anatomy of teeth, both internal and external.

Presence of accessory canals and rare anatomical configuration makes canal orifice location an important step in pulpectomy and emphasizes the need for the operator to be aware of and look out for such variations and use adequate diagnostic methodologies prior to and during therapy to detect such variations. The presence of additional canals makes it difficult to visualize additional canals like Mesio-buccal 2(MB2) and Mid mesial (MM) canal may serve as a major hindrance towards a successful outcome.

Hence, this study is planned to compare the detection rate and ease of locating root canal orifices of primary molar using surgical loupes, fluorescein sodium dye and methylene blue dye.

Methodology-

This is an in-vivo experimental trial to be carried out in department of pedodontics. Each calibrated operator will administer local anaesthesia using 2% Lignocaine with adrenaline for the procedure. Caries excavation and access opening will be achieved using round bur. The coronal pulp tissue will be amputated using a sharp sterile discoid type spoon excavator.

The Sodium Fluorescein will be prepared using Sodium Fluorescein strips. It will be dissolved in 2ml of normal saline and 2ml solution in a syringe chamber will be flooded with the dye and allow in the pulp chamber for 20 seconds. The excess dye will be evacuated with a suction apparatus. Blue curing light from photopolymerization unit illuminate the chamber. The root canal orifice will show a bright green fluorescence.

For the use of methylene blue dye- dentine will be removed where the root canal orifices are expected and 1-3 drops of dye will be inserted to the bottom of pulp cavity. After 5-10 seconds. Next the pulp cavity will be rinsed and dried. Points intensive dyed in blue will indicate the root canal orifices.

The operators will be asked to visualize the orifice of the canals. The operator 1 will locate the canals with surgical loupes and note the number of orifices followed by Operator 2 who will locate the canals using Sodium Fluorescein dye (Flurostripsterileâ„¢ sodium ophthalmic strip) or methylene blue dye and note the number of orifices.

The operators will also be asked to rate the ease of locating the no canal orifices using the different aids on a five-point Likert rating scale.

 

 

 

 

 
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