| CTRI Number |
CTRI/2024/04/066073 [Registered on: 22/04/2024] Trial Registered Prospectively |
| Last Modified On: |
26/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Assessing the fit, aesthetics, and patient preference of temporary crowns fabricated using two different fabrication techniques. |
|
Scientific Title of Study
|
Comparing Conventional and Digital Temporary Workflows for Fixed Dental Prosthesis: A Randomized Clinical Trial Evaluating Clinical Fit, Esthetic Scores, and Patient Preference. |
| 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 Amrutha Shenoy |
| Designation |
Assistant Professor |
| Affiliation |
Saveetha Dental College and Hospitals |
| Address |
Clinic 24, 4th floor, Department of Prosthodontics, Saveetha Dental College and Hospitals, Poonamallee High Road, Velapanchavadi, Chennai
Chennai
TAMIL NADU
600077
India |
| Phone |
9819122808 |
| Fax |
|
| Email |
amruthashenoyd.sdc@saveetha.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Subhabrata Maiti |
| Designation |
Associate Professor |
| Affiliation |
Saveetha Dental College and Hospitals |
| Address |
Clinic 24, 4th floor, Department of Prosthodontics, Saveetha Dental College and Hospitals, Poonamallee High Road, Velapanchavadi, Chennai
Chennai
TAMIL NADU
600077
India |
| Phone |
9916675624 |
| Fax |
|
| Email |
subhabratamaiti.sdc@saveetha.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Amrutha Shenoy |
| Designation |
Assistant Professor |
| Affiliation |
Saveetha Dental College and Hospitals |
| Address |
Clinic 24, 4th floor, Department of Prosthodontics, Saveetha Dental College and Hospitals, Poonamallee High Road, Velapanchavadi, Chennai
Chennai
TAMIL NADU
600077
India |
| Phone |
9819122808 |
| Fax |
|
| Email |
amruthashenoyd.sdc@saveetha.com |
|
|
Source of Monetary or Material Support
|
| Saveetha Dental College and Hospitals, Poonamallee High Road, Velapanchavadi, Chennai-600077, Tamil Nadu, India. |
|
|
Primary Sponsor
|
| Name |
Saveetha Dental College and Hospitals |
| Address |
Clinic 24, 4th floor, Department of Prosthodontics, Saveetha Dental College, Poonamallee High Road, Velapanchavadi |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 Amrutha Shenoy |
Saveetha Dental College and Hospitals |
Clinic 24, 4th floor, Department of Prosthodontics, Saveetha Dental College and Hospitals, Poonamallee High Road, Velapanchavadi
Chennai
TAMIL NADU |
9819122808
amruthashenoyd.sdc@saveetha.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Saveetha Dental College - Institutional Human Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K084||Partial loss of teeth, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Conventional workflow |
mock tooth preparation is done on diagnostic cast and temporary crowns are fabricated in the laboratory, which is then relined chair side in the patients mouth after tooth preparation is done. Duration of intervention is same as the day of clinical procedure. |
| Comparator Agent |
Digital temporary workflow |
Virtual tooth preparation workflow using a digital software is done to fabricate crowns before starting procedure and then the crowns are retrofitted in the patients mouth chair side, after tooth preparation. Duration of intervention is same as the time taken for clinical procedure (same day) |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
patients with complaint of single missing tooth requiring replacement with fixed dental prosthesis in upper anterior tooth region |
|
| ExclusionCriteria |
| Details |
patients with systemic illnesses, uncontrolled diabetes, poor oral hygiene, smokers, pregnant, lactating women |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| clinical fit of the crowns |
0, 1, 2 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Time efficiency, esthetic scores, patient preferences |
At baseline (immediately post clinical procedure) |
|
|
Target Sample Size
|
Total Sample Size="34"
Sample Size from India="34"
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 3 |
|
Date of First Enrollment (India)
|
01/05/2024 |
| 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)
Modification(s)
|
Closed to Recruitment of Participants |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
temporary crowns play a crucial role in protecting teeth and maintaining patients aesthetics and function between tooth preparation and final restoration. Various fabrication techniques are employed for the same. This study aims to compare the efficiency of conventional and digital workflows in terms of clinical fit, time efficiency, esthetic scores and patient preference |