| CTRI Number |
CTRI/2018/10/015919 [Registered on: 08/10/2018] Trial Registered Prospectively |
| Last Modified On: |
24/06/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparative evaluation of bone healing after root canal treatment using BioRoot RCS,AH Plus and Zinc Oxide Eugenol as root canal sealers |
|
Scientific Title of Study
|
Comparative evaluation of periapical healing after root canal treatment using three different endodontic sealers – a randomised control trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Akshay Khandelwal |
| Designation |
Post Graduate |
| Affiliation |
Saveetha Dental College and Hospitals |
| Address |
Clinic 21, Department o Conservative Dentistry and Endodontics, Saveetha dental College and Hospitals, Chennai.
Chennai
TAMIL NADU
600077
India |
| Phone |
08197961025 |
| Fax |
|
| Email |
akshay92khandelwal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ajitha P |
| Designation |
Professor |
| Affiliation |
Saveetha Dental College and Hospitals |
| Address |
Clinic 21, Department o Conservative Dentistry and Endodontics, Saveetha dental College and Hospitals, Chennai.
Chennai
TAMIL NADU
600077
India |
| Phone |
9444174551 |
| Fax |
|
| Email |
ajitharijesh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Akshay Khandelwal |
| Designation |
Post Graduate |
| Affiliation |
Saveetha Dental College and Hospitals |
| Address |
Clinic 21, Department o Conservative Dentistry and Endodontics, Saveetha dental College and Hospitals, Chennai.
Chennai
TAMIL NADU
600077
India |
| Phone |
08197961025 |
| Fax |
|
| Email |
akshay92khandelwal@gmail.com |
|
|
Source of Monetary or Material Support
|
| Gajanan Clinic, 5,Harish Mukherjee Road, Kolkata- 700025 |
|
|
Primary Sponsor
|
| Name |
Gajanan Clinic |
| Address |
5,Harish Mukherjee Road, Kolkata -700025 |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 |
| akshay khandelwal |
Saveetha Dental College and Hospitals |
Clinic 21, Department of Conservative Dentistry and Endodontics,
Saveetha dental College and hospitals,
162, Poonamalle High Rd, Velappanchavadi,Chennai
Chennai
TAMIL NADU |
8197961025
akshay92khandelwal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRB, Saveetha Dental College and Hospitals |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Patients having teeth with periapical lesion and requires root canal treatment |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
AH Plus |
Resin based Endodontic Sealer |
| Comparator Agent |
BioRoot RCS |
Tricalcium silicate based endodontic sealer |
| Intervention |
Zinc Oxide Eugenol |
Conventional Endodontic Sealer |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients requiring root canal treatment for single rooted teeth with periapical lesion and Periapical Index 2 or more. |
|
| ExclusionCriteria |
| Details |
1.Patients with delibitating dideases like diabetes, HIV, TB etc.
2.Open apex cases
3.Endo-perio lesions
4.Pregnant or lactating women
5.Root fracture cases
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Periapical Healing after root canal treatment(Radiographic evaluation) |
At 1 month and 3 months followup |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| post treatment pain |
immediate after obturation, 6 hours, 24 hrs and 1 week |
|
|
Target Sample Size
|
Total Sample Size="69"
Sample Size from India="69"
Final Enrollment numbers achieved (Total)= "63"
Final Enrollment numbers achieved (India)="63" |
|
Phase of Trial
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
13/10/2018 |
| Date of Study Completion (India) |
24/12/2019 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="7"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The success of root canal treatment depends on the elimination of the etiologic factors of the periapical pathology from the canals followed by hermetic sealing of the cleaned and shaped canals with a filling material that is biocompatible to the periapical tissues. Root canal obturation can be done with various materials and by different methods. Most commonly used is gutta percha cones used in conjugation with a sealer. Root canal Sealers are necessary to seal the space between the dentinal wall and the obturating core interface. The most popular sealers are zinc oxide-eugenol formulations, calcium hydroxide sealers, glass ionomer sealers, resin based (epoxy resin or methacrylate resin) sealers and the recently introduced calcium silicate-based sealers. Despite claims by manufacturers there is no evidence-based data, based on randomised clinical trials, demonstrating the superiority of one class of sealers over the other. Zinc oxide-eugenol sealers have a history of successful use over a long period of time. AH Plus is an epoxy resin-based root canal sealer with good physical properties, good adhesion to dentin, excellent fluidity and stability in aqueous solution. BioRoot RCS is the newest endodontic sealer based on tricyclics silicate materials benefitting from both active biosilicate technology and biodentine. BioRoot RCS is bioactive by stimulating bone physiological process and mineralization of the dentinal structure This study evaluates and compares the efficacy of BioRoot RCS, AH Plus and Zinc oxide eugenol on post obturation healing of the periapical lesions.
|