| CTRI Number |
CTRI/2025/03/083709 [Registered on: 28/03/2025] Trial Registered Prospectively |
| Last Modified On: |
26/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Bioceramic sealer vs Conventional sealer |
|
Scientific Title of Study
|
Comparative evaluation of New Bioceramic sealer vs Conventional sealer |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vivekkannan C |
| Designation |
Post Graduate |
| Affiliation |
Madha Dental College and Hospital |
| Address |
Department of Conservative Dentistry and Endodontics
Room No 5
Madha Dental College
Madha nagar
kundrathur
Department of Conservative Dentistry and Endodontics
Room No 5
Madha Dental College
Madha nagar
Chennai
TAMIL NADU
600069
India |
| Phone |
8248618322 |
| Fax |
|
| Email |
Viswavivek565@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.Susila Anand V |
| Designation |
Head Of the Department |
| Affiliation |
Madha Dental College and Hospital |
| Address |
Madha Dental College and Hospital
Madha Nagar, Kundrathur
Chennai
Chennai
TAMIL NADU
600069
India |
| Phone |
7273901234 |
| Fax |
|
| Email |
drsusila2000@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Vivekkannan C |
| Designation |
Post Graduate |
| Affiliation |
Tamil Nadu Dr.MGR Medical University |
| Address |
Madha Dental College and Hospital
Madha Nagar Kundrathur
Chennai
Chennai
TAMIL NADU
600069
India |
| Phone |
7273901234 |
| Fax |
|
| Email |
Viswavivek565@gmail.com |
|
|
Source of Monetary or Material Support
|
| Madha Dental College and Hospital
Madha Nagar, Kundrathur
Chennai 600069 |
|
|
Primary Sponsor
|
| Name |
Vivekkannan C |
| Address |
Madha Dental College and Hospital
Madha Nagar, Kundrathur
Chennai |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Madha Dental College and Hospital |
Madha Dental College and Hospital |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DrVivekkannan C |
Madha Dental College and Hospital |
Madha Dental College and Hospital
Department of Conservative Dentistry and endodontics
Room No. 5
Somangalam main road Madha Nagar kundrathur
Chennai
TAMIL NADU |
0824 861 8322
Viswavivek565@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE MADHA DENTAL COLLEGE AND HOSPITAL |
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 |
Bio-ceramic sealer |
BioActive RCS
Mineral micro-aggregate chemistry with Active Biosilicate technology. |
| Comparator Agent |
conventional sealer |
AH Plus root canal sealer
Based on epoxy-amine resin that delivers self-adhesive properties with dimensional stability and high radiopacity. |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients requiring root canal treatment who can follow treatment protocols as well as the criteria for postoperative pain evaluation |
|
| ExclusionCriteria |
| Details |
Patients with any uncontrolled systemic diseases
Patients who are pregnant
Patients who refused to participate
Teeth with open apex
Retreatments of root canals
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To reduce post operative pain and flare up after treatemnt |
Immediate post operative, 24 hours, 72 hours. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| reduced post treatment pain & good periapical seal |
immediate post operative, 24 hours, 72 hours. |
|
|
Target Sample Size
|
Total Sample Size="78"
Sample Size from India="78"
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)
|
18/04/2025 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Bio ceramic sealers are bioactive materials designed to interact with and promote healing of surrounding tissues, offering advantages over traditional sealers in biocompatibility and sealing ability. this study compares the new bio-ceramic sealer and conventional sealer based on the post operative pain, healing of periapical lesion, quality of periapical seal. The evaluation is done immediate post operative, 24 hours and 72 hours. |