FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2021/09/036338 [Registered on: 08/09/2021] Trial Registered Prospectively
Last Modified On: 31/08/2021
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Assessment of post-operative pain after the use of a new sealer for performing root canal treatment. 
Scientific Title of Study   Assessment of Post operative pain after the use of a calcium silicate based sealer. A randomized controlled clinical trial. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
Nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  A Buvaneshwari 
Designation  Assistant professor  
Affiliation  meenakshi ammal dental college 
Address  Room no 9 Department of conservative dentistry and endodontics Meenakshi Ammal Dental college No 1 Allapakkam main road Maduravoyal Chennai

Thiruvallur
TAMIL NADU
600095
India 
Phone  9551080947  
Fax    
Email  buvana.ak@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Krithika Datta 
Designation  Associate professor 
Affiliation  meenakshi ammal dental college 
Address  Room no 9 Department of conservative dentistry and endodontics Meenakshi Ammal Dental college No 1 Allapakkam main road Maduravoyal Chennai

Thiruvallur
TAMIL NADU
600095
India 
Phone  9840111369  
Fax    
Email  drkrithikadatta@hotmail.com  
 
Details of Contact Person
Public Query
 
Name  Krithika Datta 
Designation  Associate professor 
Affiliation  meenakshi ammal dental college 
Address  Room no 9 Department of conservative dentistry and endodontics Meenakshi Ammal Dental college No 1 Allapakkam main road Maduravoyal Chennai

Thiruvallur
TAMIL NADU
600095
India 
Phone  9840111369  
Fax    
Email  drkrithikadatta@hotmail.com  
 
Source of Monetary or Material Support  
SELF FUNDED 
 
Primary Sponsor  
Name  A Buvaneshwari 
Address  Room no 9 Department of conservative dentistry and endodontics Meenakshi Ammal Dental college No 1 Allapakkam main road Maduravoyal Chennai 
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 
A Buvaneshwari  Meenakshi Ammal Dental College  Room no 9 Department of conservative dentistry and endodontics Meenakshi Ammal dental college Allapakkam main road Maduravoyal Chennai 600095
Thiruvallur
TAMIL NADU 
9551080947

buvana.ak@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional review board  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  Bioceramic sealer  The root canal will be obturated with Gutta percha cones using Calcium silicate based sealer manipulated based on the manufacturers instructions.  
Comparator Agent  Resin based sealer  The root canal will be obturated with Gutta percha cones using resin based sealer manipulated based on the manufacturers instructions 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Both 
Details  Patients with irreversible pulpitis, with/ without Apical periodontitis and/ or requiring root canal treatment .
Patients having pain < 4 VAS (mild pain)
Mandibular Molar and premolar tooth with matured apex.
Periapical lesion ≤3mm
 
 
ExclusionCriteria 
Details  Patient having pain > 4 VAS (moderate to severe pain)
Curved root canals > 25 degrees
Periapical lesion ≥ 3mm
Periodontally compromised patients
Calcified root canals
Complex root canal anatomy
Grossly destructed tooth
Chronic peri- apical abscess with or without sinus
Medically compromised patients
Patients with long term drug use
Bruxism
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
post operative pain after the use of two endodontic sealers.  Post-operative pain data will be recorded in VAS scale at 2,4,6,8,24,48 hours through phone call to the patient. 
 
Secondary Outcome  
Outcome  TimePoints 
Influence of gender, pulp vitality status, periapical status and tooth type on post operative pain  Post-operative pain data will be recorded in VAS scale at 2,4,6,8,24,48 hours through  
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
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   Phase 4 
Date of First Enrollment (India)   10/09/2021 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   not yet 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

 The bioceramic materials have been shown to be less cytotoxic compared with resin-based AH Plus (Dentsply Maillefer, Ballaigues, Switzerland) in vitro. The new bioceramic sealer, Bioroot RCS (Septodont) is a water soluble sealer composed of tricalcium silicate, zirconium oxide, and calcium chloride. When in contact with physiologic solutions, these sealers release calcium ions, thereby forming an interfacial calcium phosphate (apatite) layer. This helps in developing a favorable chemical bond with the dentinal walls. Many studies have reported that BioRoot RCS has excellent flow, radiopacity and biocompatibility.However, AH exhibited stronger bonding capacity and higher radiopacity  compared with bioceramic sealers. The clinical significance of these characteristics is still unclear. Data on the clinical behavior of bioceramic sealers are scarce and of great interest. The null hypothesis states that there will be no difference in post operative pain of BioRoot RCS sealer when compared with AH Plus.

 Objectives-

1.     Evaluate the post- instrumentation pain caused by Bio Root RCS compared to AH Plus as a sealer for obturation after cleaning & shaping .

2.     Sub group analysis for gender, pulp vitality status and periapical status will be performed.

Root canal procedure:

·   Diagnosis will be confirmed based on the clinical examination and periapical x-rays. Only teeth presenting with no clinical symptoms and with a periapical score from 2 to 4 according to Orstavik et al  will be included. Cases with a widened periapical periodontal space and inadequate root canal filling corresponded to a score of 2 will be included. Teeth with large periapical lesions (score 5) will be excluded to minimize the chances of exacerbation of the local inflammatory process. Before initiating the treatment base line parameters such as age, gender, pulp status, number of cavity wall defects, diagnosis, periapical lesion are recorded.

·  During the first appointment, an access cavity will be prepared using 014 round carbide and Endo Z burs (Dentsply International, York, PA, USA) under local anaesthesia (lidocaine hydrochloride and epinephrine 1:80,000; Xilonibsa, Inibsa, Spain) and rubber dam isolation following which the root canals will be located.

·   Working length will be established 0.5mm short of the minor foramen, using a propex pixi apex locator (dentsply mallifer), which will be confirmed radiographically.  Cleaning and shaping will be done using Mtwo files. Master apical file preparation between # 25 to #40 according to initial apical file. 17% EDTA gel will be used as the lubricant with the Mtwo file system. 

IRRIGATION PROTOCOL:

·      Irrigation with 3 mL of 3% NaOCl (Parcan; Septodont, Delhi, India) will be  performed between each file. After instrumentation of the root canal, 5 mL of 17% Ethylenediamine tetraacetic acid (17% EDTA) solution (Dent Wash; Prime Dental Products Pvt. Ltd., Thane, India) will be used for smear layer clearance. Following this, irrigation with 5 mL of 0.9% physiological saline solution will be done. All the above will be done using a 30-gauge side vented needle (Maxi-I-probe; Dentsply, Tulsa Dental, York, PA, USA), 1 mm short of working length.  In both the groups, passive ultrasonic irrigation will be performed by ultrasonically passively activating 1 ml of 3% sodium hypochlorite (NaOCl) in the root canal using a stainless-steel #15 K-type file mounted in a piezoelectric ultrasonic device (Enac-Osada, Tokyo, Japan) at a power setting of 3 for 20 seconds followed by 0.5 mL 3% NaOCl for 10 seconds to the working length (WL). This 30-second cycle will be repeated 3 times. The ultrasonic instrument will be used at 1 mm short of the WL. Smear layer will then be removed using 2 mL of 17% Ethylenediaminetetraacetic acid (EDTA) activated for 60 seconds with a total contact time of 2 mins with the canal walls and activated in the same manner, followed by a final rinse with 2 mL of distilled water activated for 1 min.

 

           Patients will be randomised to the following groups:

1.     Group 1: Calcium silicate  based sealer (BioRoot RCS)

2.     Group 2: Resin Based sealer (AH plus).

OBTURATION :

·      The root canal sealer will be prepared according to the manufacturer’s instructions. After drying with paper points, a small amount of the sealer was introduced into the canal with a smaller gutta percha point. A master gutta-percha point will be adapted, and the canal was obturated by lateral condensation using lateral gutta percha points. Post-instrumentation pain data will be recorded in VAS scale at 2,4,6,8,24,48 hours through phone call to the patient.




 
Close