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CTRI Number  CTRI/2021/12/038714 [Registered on: 17/12/2021] Trial Registered Prospectively
Last Modified On: 16/12/2021
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   comparison of three endodontic systems in maintaining original internal root canal anatomy 
Scientific Title of Study   Standardization of endodontic protocol in armed forces : A comparative CBCT guided invivo analysis of three contemporary endodontic systems ability in maintaining original internal root canal anatomy : A prospective multicentric randomized controlled trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Col Sonali Sharma 
Designation  Professor & HoD 
Affiliation  Army dental center research and referral 
Address  Department of Conservative dentistry and endodontics, Second floor, C wing, Army dental center research and referral , Delhi

South West
DELHI
110010
India 
Phone    
Fax    
Email  sonaliendo@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Col Sonali Sharma 
Designation  Professor & HoD 
Affiliation  Army dental center research and referral 
Address  Department of Conservative dentistry and Endodontics, Second floor, C wing, Army dental center research and referral , delhi

South West
DELHI
110010
India 
Phone    
Fax    
Email  sonaliendo@gmail.com  
 
Details of Contact Person
Public Query  
Name  Col Sonali Sharma 
Designation  Professor & HoD 
Affiliation  Army dental center research and referral 
Address  Department of Conservative dentistry and Endodontics, Second floor, C wing, Army dental center research and referral , delhi

South West
DELHI
110010
India 
Phone    
Fax    
Email  sonaliendo@gmail.com  
 
Source of Monetary or Material Support  
Army Dental Center research and referral, Delhi 
 
Primary Sponsor  
Name  DGAFMS 
Address  Armed forces medical research cell Army dental centre Delhi 
Type of Sponsor  Research institution and hospital 
 
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 
Col Sonali Sharma  Army Dental Center  Department of Conservative Dentistry and Endodontics, Second floor, C wing, Army Dental Center research and referral, delhi
South West
DELHI 		 9717888513

sonaliendo@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
army dental center research and referral  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  dental disease requiring endodontic intervention 
Patients  (1) ICD-10 Condition: K044||Acute apical periodontitis of pulpal origin,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  CBCT guided comparison of canal centering ability  comparison of canal centering ability of three different endodontic file systems using CBCT. Canal centering ability was evaluated by comparing Pre operative CBCT and Post operative CBCT taken after Chemomechanical preparation using rotary, reciprocating and vibratory adaptive file systems in groups A, B, C. A duration of 1 week gap was maintained between the two CBCT. 
Intervention  endodontic treatment  endodontic treatment using three different file systems Chemomechanical preparation of root canals using file systems operating in rotary, reciprocating, vibratory adaptive motions respectively in groups A, B, C. the total duration of which endodontic treatment was carried out was within 3-4 weeks 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  90 patients 
 
ExclusionCriteria 
Details  tooth with severe anatomic variations 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
vibratory adaptive file systems maintains original root canal morphology and had maximal instrumented root surfaces  Canal centering ability and canal transportation was measured both buccolingually and mesiodistally using preoperative CBCT and post operative CBCT taken 1 week after chemomechanical preparation by rotary, reciprocating and vibratory adaptive file system 
 
Secondary Outcome  
Outcome  TimePoints 
maintainance of original canal morphology in C shaped canals,
incidenence of instrument seperation, time taken for chemomechanical preparation 		 Canal centering ability and canal transportation in C shaped canals was measured both buccolingually and mesiodistally using preoperative CBCT and post operative CBCT taken 1 week after chemomechanical preparation by rotary, reciprocating and vibratory adaptive file system.
Incidence of instrument seperation in all the cases prepared using three different endodontic file systems was evaluated. time taken for mechanical preparation using each file system was evaluated  
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
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)   28/12/2021 
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 Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  


(a) Purpose of the study : To formulate a standardized, simplified and minimal inventory based root canal preparation protocol which aids in maintaining the internal root canal anatomy to give a predictable endodontic outcome.


(b) Objectives : 

i. To compare the canal centering ability and maintaining of original internal root canal anatomy while canal preparation with Rotary, Reciprocating systems and Self adjusting File Systems.

ii. To compare and contrast instrumented areas of root canal wall by the various systems

iii. To compare the time efficiency of various contemporary endodontic systems.

Study Design

90 Patients age 18 years to 50 years reporting to dental centre requiring primary endodontic treatment in mandibular molars will be included in the study. Informed consent will be taken. The patients will be randomly assigned into three groups of 30 samples each. In Group A cases, root canal will be prepared by rotary system using Hyflex files, Group B by reciprocating system using Wave One files and Group C by a self-adjusting vibratory adaptive file system. Complete canal cleaning and shaping will be completed in one sitting.  Prior preparation, the tooth will be imaged by CBCT. Then the tooth in consideration will be prepared with the assigned instrument by following manufacturer instructions and adhering to conventional endodontic protocol of isolation, access preparation, cleaning and shaping. After preparation, the tooth is again imaged by CBCT, canals will be metrically assessed for changes in curvature and transportation during canal preparation, mean total widths and outer and inner width measurements will be determined on each central canal path and differences will be statistically analyzed. Areas of uninstrumented root canal wall will also be noted. Time taken for canal preparation will be noted.

The preparations will be analyzed according to Schilder’s mechanical objectives of canal preparation i.e original internal anatomy maintained, canal centering ability and canal has a continuous smooth curve from canal orifice to apical terminus.

•       Canal transportation (CT) is calculated by formula (CT) = (M1 - M2) - (D1 - D2)

•       Centralization ability ratio   = (M1 - M2)/ (D1 - D2)  

•       Result = 1.0 micron m is perfect centralization

•        Result closer to zero indicates poor centralization 

M1 is the measurement of the quantity of voxels from the external surface of the mesial portion of the root to the mesial wall of the non-instrumented canal M2 is the measurement of the quantity of voxels from the external root surface of the mesial portion of the root to the wall of the canal after instrumentation. D1 is the measurement of the quantity of voxels of the external surface of the distal portion of the root to the distal wall of the no instrumented canal. D2 is the measurement of the quantity of voxels from the external surface of the distal portion of the root to the distal surface of the canal after instrumentation.

The instrument separation will be evaluated once the above procedure is completed. The used file will be then used to prepare more samples till marked deformation of file is noted visually. The total number of samples which can be prepared without deformation or separation will be noted. Data will be collected and it will be compiled, comprehensively analyzed and statistical analysis will be done.

Resume of relevant literature on the subject, with special reference to the areas in which information is lacking:

Important principle of endodontics is to maintain the original canal anatomy while striving for a continuous tapering preparation [1]. It relates to the ability of the instrument to uniformly prepare all the surfaces of the canal, thus enabling the central axis of the prepared canal coincide with that of the original canal, especially relevant in the canals with curvatures [2,3]. Centering ability a desirable quality is influenced both by the design of the instrument (taper, flexibility, type of alloy) and the root canal anatomy is also an important desirable quality [4-8].

Rotary instrumentation systems have resulted in procedural errors leading to failures [1-3]. Thus, oscillatory or reciprocating system were explored. The shaping of simulated canals was more centered using a reciprocating motion when compared to continuous rotation, but was more time consuming and require a dedicated endomotor.

 

The recent addition is Self-Adjusting File (SAF), a vertical vibratory adaptive system of compressible lattice made from hollow nickel titanium cylinder with inherent metal memory which expands in canal, adapting to the shape in three dimensions. SAF incorporates an irrigation source through its hollow lattice design, allowing simultaneous irrigation and disinfection of the canal [9].

 

 CBCT imaging owing to low radiation dose, fast scan and sub millimetric resolution is an effective tool to evaluate and measure dentin thickness, canal curvature, apical transportation, and canal centering, as it provides images in orthogonal planes as well as in oblique planes [10].  

 REFERENCES (maximum 8)         

1.    Luis Cardoso Rasquin, Fabíola Bastos de Carvalho, Regina Karla de Pontes Lima. IN Vitro Evaluation Of Root Canal Preparation Using Oscillatory And Rotary Systems In Flattened Root  Canals. J Appl Oral Sci. 2007; 15(1) : 65-9.

2.    Mateus Silveira Martins, Vânia Regina Camargo , José Roberto,Volmir João, Fernando Branco. CT Evaluation of Apical Canal Transportation Associated with Stainless Steel Hand Files, Oscillatory Technique and ProTaper Rotary System. Braz Dent J 2011; 22(4): 288 -293.

3.    Renato de Toledo Leonardo. ENDO-EZE Tilos Anatomic Endodontic Technology. Oral Health Journal, 2010; 6:1-7.

4.    Mathieu Goldberg, Sandrine Dahan, and Pierre Machtou . Centering Ability and Influence of Experience When Using WaveOne Single-File Technique in Simulated Canals. International Journal of Dentistry,2012; Article ID 206321: 1-7

5.     Ruttermann S  et al. Preparation of the coronal and middle third of oval root canals with a rotary or an oscillating system. Oral Surg Oral Med Oral Pathol Oral Radiol Endod 2007; 104:852-6.

6.    Sung-Yeop You, Cheol, Kim. Shaping Ability of Reciprocating Motion in Curved Root Canals: A Comparative Study with Micro–Computed Tomography. J Endod 2011:1–5.

7.    Anisha Merh et al. To Comparatively Evaluate the Canal Centering Ability of the ENDO EZE AET System and Wave One System in Simulated Canals National Journal of Medical and Dental Research, Jan-March 2014; 2(2):32-41.

8.    Zohreh Khalik et al.canal centering ability of three rotary file systems in simulated canals.A comparative  study. Indian Dent Res 2009; 20 (4)  

9.    Cohen S et al. The SAF Endo System: adaptive 3 D Cleaning and Shaping and

Disinfection. Endodontic Practice 2011; 4(7).

 
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