| CTRI Number |
CTRI/2025/10/095764 [Registered on: 09/10/2025] Trial Registered Prospectively |
| Last Modified On: |
08/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Other |
|
Public Title of Study
|
Comparing the Fit of Cast Metal vs. CAD-CAM Post and Core Restorations: An In-Vivo Study |
|
Scientific Title of Study
|
An in-vivo comparative evaluation of clinical and radiographic accuracy of fit of
cast metal post and core with CAD-CAM post and core: A prospective 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 Divya Deelip Nalavade |
| Designation |
Post graduate student |
| Affiliation |
government dental college and hospital mumbai |
| Address |
Department of Conservative Dentistry and endodontics, Government Dental College And Hospital, Fort Area, Mumbai
Mumbai MAHARASHTRA 400001 India |
| Phone |
9834865547 |
| Fax |
|
| Email |
divnal2000@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Abrar Sayed |
| Designation |
|
| Affiliation |
government dental college and hospital mumbai |
| Address |
Department of Conservative Dentistry and endodontics, Government Dental College And Hospital , Fort Area, Mumbai
Mumbai MAHARASHTRA 400001 India |
| Phone |
|
| Fax |
|
| Email |
abrars79@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Divya Deelip Nalavade |
| Designation |
Post Graduate Student |
| Affiliation |
government dental college and hospital mumbai |
| Address |
Department of Conservative Dentistry and endodontics, Government Dental College And Hospital, Fort Area, Mumbai
Mumbai MAHARASHTRA 400001 India |
| Phone |
9834865547 |
| Fax |
|
| Email |
divnal2000@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Conservative Dentistry and Endodontics, Government Dental College And Hospital,Mumbai, India 400001 |
|
|
Primary Sponsor
|
| Name |
Dr Divya Deelip Nalavade |
| Address |
Department of Conservative Dentistry and Endodontics, Government Dental College And Hospital, Mumbai, India 400001 |
| 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 Divya Deelip Nalavade |
Government Dental College and Hospital Mumbai |
Room No. 101, Department of Conservative Dentistry and Endodontics Mumbai MAHARASHTRA |
9834865547
divnal2000@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Government Dental College and Hospital Mumbai |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
patients requiring post and core treatment |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
CAD/CAM post and core |
A post and core is used to restore teeth that have undergone endodontic therapy and have significant loss of coronal structure. Traditionally, posts were cast in metal, but advancements in Computer-Aided Design and Computer-Aided Manufacturing (CAD-CAM) technology have introduced new possibilities for creating highly accurate, esthetic, and biocompatible post and core restorations. |
| Intervention |
Cast post and core |
A cast post and core is a custom-made metallic restoration fabricated in a dental laboratory to fit precisely into the prepared root canal and provide retention for a crown. It has been considered the gold standard for decades because of its high strength, adaptability to root canal anatomy, and proven clinical performance. Duration can be 1-2 years |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Single-rooted permanent maxillary incisor teeth.
In patients indicted for Post and core
Post length 8 to 12 mm after radiographic assessment |
|
| ExclusionCriteria |
| Details |
Multirooted teeth
Teeth with severe root curvature
Mobile teeth
Maxillary incisor teeth with more than one root canal
Teeth with fusion, gemination, and dilaceration |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate the accuracy of fit of the cast metal post and core.
To evaluate the accuracy of the fit of the CAD-CAM post and core.
To compare the accuracy of fit of cast metal post and core with CAD-CAM post and
core. |
At baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="12" Sample Size from India="12"
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)
|
06/11/2025 |
| 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="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 - NO
|
|
Brief Summary
|
The longevity and success of post and core restorations largely depend on the accuracy of fit between the post and the prepared root canal. Traditionally, cast metal posts and cores have been considered the gold standard due to their strength and adaptability. However, the advent of CAD-CAM technology offers a digital alternative that promises improved precision, reduced chairside time, and better standardization. This clinical trial aims to comparatively evaluate the clinical and radiographic accuracy of fit between cast metal post and core and CAD-CAM fabricated post and core systems, to determine which method provides superior adaptation and clinical performance. |