| CTRI Number |
CTRI/2024/07/070005 [Registered on: 04/07/2024] Trial Registered Prospectively |
| Last Modified On: |
20/07/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparing the Effectiveness of Two Bio-Ceramic Sealers in Treating Necrosed Teeth: A 6-Month Study Using CBCT-Advanced Imaging Technology
|
|
Scientific Title of Study
|
A comparative 6 months evaluation of clinical
and radiographic outcome of necrotic single
rooted teeth obturated using two different bioceramic sealers : A CBCT-based randomized
clinical study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Riddhi Vasa |
| Designation |
PG Student |
| Affiliation |
K.M. Shah dental college and hospital |
| Address |
Department of Conservative Dentistry and Endodontics, K.M. SHAH Dental College and Hospital Sumandeep Vidyapeeth Waghodia, Vadodara 391760
Vadodara
GUJARAT
391760
India |
| Phone |
8583097772 |
| Fax |
|
| Email |
vasariddhi1@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ajay Singh Rao |
| Designation |
Professor |
| Affiliation |
K.M. Shah dental college and hospital |
| Address |
Department of Conservative Dentistry and Endodontics, K.M. SHAH Dental College and Hospital Sumandeep Vidyapeeth Waghodia, Vadodara 391760
Vadodara
GUJARAT
391760
India |
| Phone |
8385017307 |
| Fax |
|
| Email |
drajayinendo@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ajay Singh Rao |
| Designation |
Professor |
| Affiliation |
K.M. Shah dental college and hospital |
| Address |
Department of Conservative Dentistry and Endodontics, K.M. SHAH Dental College and Hospital Sumandeep Vidyapeeth Waghodia, Vadodara 391760
Vadodara
GUJARAT
391760
India |
| Phone |
8385017307 |
| Fax |
|
| Email |
drajayinendo@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Conservative dentistry and endodontics K.M. Shah dental college and hospital |
|
|
Primary Sponsor
|
| Name |
Dr Riddhi Vasa |
| Address |
8, Department of Conservative Dentistry and Endodontics, K.M. SHAH Dental College and Hospital Sumandeep Vidyapeeth Waghodia, Vadodara 391760 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Dr Ajay Singh Rao |
K.M. SHAH DENTAL COLLEGE AND HOSPITAL |
8, Department of Conservative Dentistry and Endodontics, K.M. SHAH Dental College and Hospital Sumandeep Vidyapeeth Waghodia, Vadodara 391760
Vadodara
GUJARAT |
08385017307
drajayinendo@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sumandeep Vidyapeeth Instituitional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K041||Necrosis of pulp, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Angelus Bio-C Sealer |
COMPOSITION: Tricalcium silicate, Dicalcium silicate, Tricalcium Aluminate, Calcium Oxide, Silicon Oxide, Zirconium Oxide, Polyethylene Glycol and Iron Oxide
ROUTE OF ADMININSTRATION: IT WILL BE USED AS AN INTRACANAL MEDICAMENT
FREQUENCY AND DOSE: WILL BE PLACED ONCE IN THE ROOT CANAL AT THE TIME OF TREATMENT WITH A DOSE OF 0.05mg per canal. |
| Comparator Agent |
Ceraseal Bio-ceramic Sealer |
Composition: zirconium dioxide, 40%, tricalcium silicate 20-30%, dicalcium silicate 1-10%, tricalcium aluminate 1-10%
ROUTE OF ADMINISTRATION: IT WILL BE USED AS AN INTRACANAL MEDICAMENT
FREQUENCY AND DOSE: IT WLL BE PLACED ONCE IN THE ROOT CANAL AT THE TIME OF TREATMENT WITH A DOSE OF 0.05 mg per canal. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Inclusion criteria
1.Systemically healthy patients (Category: American Society of Anesthesiologists Class 2 or less than 2) 25 between 18 – 65 years of age.
2.Maxillary or mandibular single rooted teeth diagnosed with Pulpal necrosis with symptomatic or asymptomatic apical periodontitis with lesions that show periapical radiolucency with (CBCTPAI) Score 323 will be included in the study.
3.Re-treatment cases with periapical lesions with CBCTPAI Score 3 will be included in the study.
4.A written informed consent will be taken from all the patients and only those patients ready to sign the consent form will be included in the study.
|
|
| ExclusionCriteria |
| Details |
Exclusion criteria
1.Pregnant and lactating women will be excluded.
2 Patients having teeth with poor prognosis, open apices, internal/external resorption, fractured Roots or visibly cracked tooth, grade 3 mobility, severe periodontal bone loss will be excluded from the study
3.Patients having teeth with complex root canal morphology such as Calcified canals, extreme curvatures or anomalies will be excluded from the study.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Healing of Periapical lesions is expected to be better than Cera seal bio-ceramic sealer in approximately 20 samples |
Healing of periapical lesions will be assessed at baseline and after 6 months. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| PERIAPICAL HEALING WILL BE ASSESED ON CBCT AT BASELINE AND AFTER 6 MONTHS |
At baseline & after 6 months interval. |
|
|
Target Sample Size
|
Total Sample Size="48"
Sample Size from India="48"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
01/08/2024 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
01/08/2024 |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
The present study aims to compare the clinical and radiographic outcome of single rooted teeth obturated using hydraulic condensation technique with two different bio-ceramic sealer (Angelus Bio- C Sealer and Ceraseal Bio-ceramic Sealer) on a CBCT in patients with Periapical lesions having CBCTPAI score of 3 or above.
It will be a 6 month follow-up study. |