| CTRI Number |
CTRI/2024/01/062073 [Registered on: 30/01/2024] Trial Registered Prospectively |
| Last Modified On: |
22/01/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Other |
|
Public Title of Study
|
Accuracy of various digital scanners on milled crowns. A Clinical trial. |
|
Scientific Title of Study
|
Comparison of the accuracy of various digital scanners on ceramic milled crowns using the silicone replica method. A Clinical Trial. |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sashwat Sathish |
| Designation |
Post Graduate |
| Affiliation |
Saveetha Denatal College and Hospital, Saveetha Institute of medical and technical sciences |
| Address |
Department of Endodontics and Conservative dentistry, Saveetha Dental College and Hospital
162, Poonamallee High Rd, Velappanchavadi, Chennai
Chennai
TAMIL NADU
600077
India |
| Phone |
8754555886 |
| Fax |
|
| Email |
152106007.sdc@saveetha.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Manish Ranjan |
| Designation |
Professor |
| Affiliation |
Saveetha Denatal College and Hospital, Saveetha Institute of medical and technical sciences |
| Address |
Department of Endodontics and Conservative dentistry, Saveetha Dental College and Hospitals
162, Poonamallee High Rd, Velappanchavadi, Chennai
Chennai
TAMIL NADU
600077
India |
| Phone |
9543445029 |
| Fax |
|
| Email |
manis@saveetha.com |
|
Details of Contact Person
Public Query
|
| Name |
Manish Ranjan |
| Designation |
Professor |
| Affiliation |
Saveetha Denatal College and Hospital, Saveetha Institute of medical and technical sciences |
| Address |
Department of Endodontics and Conservative dentistry, Saveetha Dental College and Hospitals
162, Poonamallee High Rd, Velappanchavadi, Chennai
TAMIL NADU
600077
India |
| Phone |
9543445029 |
| Fax |
|
| Email |
manis@saveetha.com |
|
|
Source of Monetary or Material Support
|
| Sashwat Sathish
Post Graduate,
Department of Endodontics and Conservative dentistry, Saveetha Dental College and Hospitals, |
|
|
Primary Sponsor
|
| Name |
Sashwat Sathish |
| Address |
162, Poonamallee High Rd, Velappanchavadi, Chennai, Tamil Nadu 600077 |
| 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 |
| sashwat sathish |
Saveetha Dental college and hospital |
Department of Endodontics and Conservative dentistry,162, Poonamallee High Rd, Velappanchavadi, Chennai, Tamil Nadu 600077
Chennai
TAMIL NADU |
8754555886
152106007.sdc@saveetha.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human Ethical Comittee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K049||Other and unspecified diseases ofpulp and periapical tissues, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
control- 3shape trios intraoral scanner
Intervention - Prime scan intraoral scanner
|
scans will be taken to place a crown in molars post root canal therapy by both intraoral scanners and the marginal fit is checked intra orally |
| Intervention |
control- 3shape trios intraoral scanner Intervention - Prime scan intraoral scanner |
scans will be taken to place a crown in molars post root canal therapy by both intraoral scanners and the marginal fit is checked intra orally |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Presence of adjacent and opposing teeth
Age – 18 years and above
RCT treated teeth
Tessera milling as standard
|
|
| ExclusionCriteria |
| Details |
Absence of adjacent and opposing teeth.
Unrestorable teeth.
Patient with limited mouth opening and TMJ issued.
Lower incisors
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare the accuracy of CEREC Primescan and 3Shape TRIOS using the silicone replica technique to measure the bi-planar fit at 20 points for milled ceramic crowns.
|
Nil
No follow up |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Time taken for scanning to be done & time taken to design the crown will be recorded |
Nil
No follow up |
|
|
Target Sample Size
|
Total Sample Size="17"
Sample Size from India="17"
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 1 |
|
Date of First Enrollment (India)
|
01/02/2024 |
| 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="0"
Months="4"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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 - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- 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 [152106007.sdc@saveetha.com].
- For how long will this data be available start date provided 31-03-2024 and end date provided 01-01-2025?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Aim: To compare the clinical accuracy of Primescan Intra Oral Scanner and 3Shape TRIOS post milling via silicone replica method Null Hypothesis: There is no difference in accuracy between the intra-oral scanners 3Shape TRIOS and Primescan. Alternate Hypothesis: There is a difference in accuracy between the intra-oral scanners 3Shape TRIOS and Primescan.
|