| CTRI Number |
CTRI/2024/03/064511 [Registered on: 20/03/2024] Trial Registered Prospectively |
| Last Modified On: |
23/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [fixed dental prosthesis] |
| Study Design |
Other |
|
Public Title of Study
|
Comparison of Methods for Making Temporary Crowns: A Study on Gum Health and Patient Satisfaction |
|
Scientific Title of Study
|
Comparative Analysis of Periodontal Parameters And Patient Satisfaction Utilizing Different Temporary Crown Fabrication Techniques: a randomised 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 |
Amrutha Shenoy |
| Designation |
Assistant Professor |
| Affiliation |
Saveetha Dental College |
| Address |
Clinic 24, 4th floor, Department of Prosthodontics, Saveetha Dental College and Hospitals, Poonamallee High Road, Velapanchavadi, Chennai- 600077
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 |
| Address |
Clinic 24, 4th floor, Department of Prosthodontics, Saveetha Dental College and Hospitals, Poonamallee High Road, Velapanchavadi, Chennai- 600077
Chennai
TAMIL NADU
600077
India |
| Phone |
9819122808 |
| Fax |
|
| Email |
subhabratamaiti.sdc@saveetha.com |
|
Details of Contact Person
Public Query
|
| Name |
Amrutha Shenoy |
| Designation |
Assistant Professor |
| Affiliation |
Saveetha Dental College |
| Address |
Clinic 24, 4th floor, Department of Prosthodontics, Saveetha Dental College and Hospitals, Poonamallee High Road, Velapanchavadi, Chennai- 600077
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, Tamil Nadu, India 600077 |
|
|
Primary Sponsor
|
| Name |
Saveetha Dental College |
| Address |
Clinic 24, 4th floor, Department of Prosthodontics, Saveetha Dental College and hospitals, Poonamallee High Road, Chennai -600077 |
| 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, Chennai
Chennai - 600077
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 Clearance |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K056||Periodontal disease, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
direct method of fabrication |
it is a technique of temporary tooth fabrication where in tooth wax up is done using wax, temporary prosthesis fabricated using bisacryl material using a putty index. this is done chair side. Outcomes assessed immediately post procedure (same day) |
| Comparator Agent |
direct-indirect method |
It is. a technique where in temporary prosthesis is ready beforehand using diagnostic impression from the lab using CAD/CAM technology, before starting with the treatment and relined after tooth preparation chair side. Outcomes assessed immediately post procedure (same day) |
| Comparator Agent |
indirect method of fabrication |
it is a technique of temporary prosthesis fabrication wherein in impression is recorded and then sent to lab for fabrication of crowns using CAD/CAM technology. Outcomes assessed immediately post procedure (same day) |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
patients requiring fixed dental prosthesis (single crowns) in the anterior region. |
|
| ExclusionCriteria |
| Details |
patients with systemic illnesses, uncontrolled diabetes, periodontal disease, h/o smoking, or use of tobacco, pregnant, lactating women |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
PES scores
Probing depth
Plaque index
|
1 week post cementation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Patient satisfaction |
at the time of evaluation |
|
|
Target Sample Size
|
Total Sample Size="27"
Sample Size from India="27"
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)
|
30/03/2024 |
| 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="2"
Days="3" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
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 prepared teeth and maintaining patients’ aesthetics and function between tooth preparation and final restoration placement. Various fabrication techniques are employed to create temporary crowns, each with potential implications for periodontal health and patient satisfaction. This study aims to compare the effects of different temporary crown fabrication techniques on periodontal parameters and patient satisfaction. |