| 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
|
|
|
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
|
|
|
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
|
|
|
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. |