| CTRI Number |
CTRI/2024/08/072414 [Registered on: 12/08/2024] Trial Registered Prospectively |
| Last Modified On: |
12/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Non-randomized, Multiple Arm Trial |
|
Public Title of Study
|
Comparative Evaluation Of Two Obturating System Using CBCT And IOPA |
|
Scientific Title of Study
|
Comparative Evaluation of Two Different Obturating Systems Using CBCT and IOPA – An In Vivo 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 DEVIKA B MISHRA |
| Designation |
Post Graduate |
| Affiliation |
NIMS University |
| Address |
Department of Conservative Dentistry and Endodontics,
Room no. 5,
NIMS Dental college and Hospital,
NIMS University, JAIPUR, RAJASTHAN, 303121
Jaipur
RAJASTHAN
303121
India |
| Phone |
9975697276 |
| Fax |
|
| Email |
devika.mishra1996@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Rachit Mathur |
| Designation |
Professor |
| Affiliation |
NIMS University |
| Address |
NIMS Dental College and Hospital,
NIMS University, JAIPUR, RAJASTHAN, 303121
Jaipur
RAJASTHAN
303121
India |
| Phone |
9828628808 |
| Fax |
|
| Email |
rachit2m@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr DEVIKA B MISHRA |
| Designation |
Post Graduate |
| Affiliation |
NIMS University |
| Address |
Department of Conservative Dentistry and Endodontics,
Room no.5,
NIMS Dental College and Hospital,
NIMS University,
JAIPUR,
RAJASTHAN,
303121
Jaipur
RAJASTHAN
303121
India |
| Phone |
9975697276 |
| Fax |
|
| Email |
devika.mishra1996@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr. Devika Mishra
NIMS Dental College and Hospital
NIMS University
Jaipur, Rajasthan |
|
|
Primary Sponsor
|
| Name |
DEVIKA MISHRA |
| Address |
NIMS UNIVERSITY, JAIPUR, RAJASTHAN |
| 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 |
| Dr Devika Mishra |
NIMS Dental College and Hospital |
Department of Conservative Dentistry and Endodontics,
Room no. 5,
NIMS Dental College and Hospital,
NIMS University Jaipur
Jaipur
RAJASTHAN |
9975697276
devika.mishra1996@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Office of the Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K045||Chronic apical periodontitis, (2) ICD-10 Condition: Z020||Encounter for examination for admission to educational institution, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Obtura II |
Obturation using OBTURA II and post obturation evaluation using cbct |
| Comparator Agent |
Obtura II |
Obturation using OBTURA II and post obturation evaluation using iopar |
| Intervention |
Thermafil |
Obturation using thermafil followed by post obturation radiographic evaluation using cbct. |
| Intervention |
Thermafil |
Obturation using thermafil followed by post obturation radiographic evaluation using iopar |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patient with acute and chronic irreversible pulpitis in single rooted premolars.
Patient with acute and chronic apical periodontitis in single rooted premolars.
Patient with pulpal necrosis in single rooted premolars.
Patient in the age group of 20 and 60 years |
|
| ExclusionCriteria |
| Details |
Patient with systemic disease.
Pregnant and lactating women.
Teeth with incomplete root formation.
Teeth with severe periodontal problem.
Teeth requiring retreatment.
Inability to provide informed consent.
Patients having more than one tooth requiring root canal treatment.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| after evalution using cbct and iopa it was concluded that thermafil showed lesser voids compared to obtura 2 |
at baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| visual analogue scale evaluted pain on obturation with obtura 2 |
at baseline |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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 2 |
|
Date of First Enrollment (India)
|
27/08/2024 |
| 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 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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Informed Consent Form
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [devika.mishra1996@gmail.com].
- For how long will this data be available start date provided 05-08-2024 and end date provided 05-07-2027?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
The primary goals of endodontic treatment are to fully decontaminate the root canal system and eliminate any potential for reinfection in the future. Appropriate endodontic procedure sealing in three dimensions is crucial to achieving these goals because it lowers the likelihood of microbial proliferation and the development of pathological processes later on. Since bacteria can multiply in voids formed during obturaton when exposed to nutrients through the periapical region or lateral canals, these voids could constitute an invasion. Although there are numerous methods to complete the root canal procedure: Apical "barrier"; Thermomechanical compaction; Single cone; Lateral compaction (warm and cold); Vertical compaction (continuous and interrupted wave). Thermafil offers low sealer thickness, a greater level of uniformity and a void-free obturation. Obtura II can be employed in challenging situations including channel calcifications, perforations, open apex (blunderbuss), curved canals, and intercanal resorptions thanks to thermoplasticized guttapercha with obtura II. However, length control has drawbacks, including increased risk of both under- and overextended obturations. Considering its inherent drawbacks, conventional radiography is still the imaging technology of choice in the field. But when it comes to evaluating the distinct anatomy of the maxillofacial bone, the advancement of CBCT has brought to light the shortcomings of traditional radiography. |