| CTRI Number |
CTRI/2024/03/064269 [Registered on: 18/03/2024] Trial Registered Prospectively |
| Last Modified On: |
07/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of two types of ceramic replacements for broken front teeth |
|
Scientific Title of Study
|
A Comparative Evaluation between Conventional Ceramic Veneer and Partial Ceramic Veneer for Ellis Class II Restorations |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shruthi Rajagopal |
| Designation |
Post Graduate Student |
| Affiliation |
Saveetha Dental College And Hospitals, Saveetha Institute of Medical and Technical Sciences |
| Address |
Department of Conservative Dentistry and Endodontics, Clinic-21, 162, Poonamallee High Rd, Velappanchavadi
Chennai
TAMIL NADU
600077
India |
| Phone |
8369645027 |
| Fax |
|
| Email |
152106008.sdc@saveetha.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Subash Sharma |
| Designation |
Professor |
| Affiliation |
Saveetha Dental College And Hospitals, Saveetha Institute of Medical and Technical Sciences |
| Address |
Department of Conservative Dentistry and Endodontics, Clinic-21, 162, Poonamallee High Rd, Velappanchavadi
Chennai
TAMIL NADU
600077
India |
| Phone |
9884533118 |
| Fax |
|
| Email |
subash@saveetha.com |
|
Details of Contact Person
Public Query
|
| Name |
Shruthi Rajagopal |
| Designation |
Post Graduate |
| Affiliation |
Saveetha Dental College And Hospitals, Saveetha Institute of Medical and Technical Sciences |
| Address |
Department of Conservative Dentistry and Endodontics, Clinic-21, 162, Poonamallee High Rd, Velappanchavadi
Chennai
TAMIL NADU
600077
India |
| Phone |
8369645027 |
| Fax |
|
| Email |
152106008.sdc@saveetha.com |
|
|
Source of Monetary or Material Support
|
| Saveetha Dental College and Hospitals |
|
|
Primary Sponsor
|
| Name |
Saveetha Dental College and Hospitals |
| Address |
162, Poonamallee High Rd, Velappanchavadi, Chennai, Tamil Nadu 600077 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Shruthi Rajagopal |
Saveetha Dental College and Hospitals |
Department of Conservative Dentistry and Endodontics, Clinic-21 162, Poonamallee High Rd, Velappanchavadi
Chennai
TAMIL NADU |
8369645027
152106008.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 |
| Comparator Agent |
Conventional Ceramic veneer |
For patients with fractured anterior teeth opting for treatment with ceramic veneers, the preparation of finish line will be done at the cervical third of the tooth. After digital scanning, temporisation is done following which patient is recalled for final cementation. |
| Intervention |
Partial Ceramic Veneer |
For patients with fractured anterior teeth opting for treatment with ceramic veneers, the preparation of finish line will be done just beyond the fracture line. After digital scanning, temporisation is done following which patient is recalled for final cementation. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
59.00 Year(s) |
| Gender |
Both |
| Details |
Ellis Class II fracture in anterior teeth due to trauma. Patients cooperative and willing to return for follow up |
|
| ExclusionCriteria |
| Details |
Extensive loss of tooth structure due to caries
Extensive loss of enamel and pulpal exposure
Non vital teeth with periapical pathosis
Orofacial deformities eg. cleft lip and palate
Severe Malocclusion (eg. CLASS III,OPEN BITE)
Parafunctional habits
Long term systemic disorders
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
USPHS CRITERIA :
Adaptation
Colour match
Marginal Discolouration
Fracture of Restoration
Fracture of the tooth
Caries
Postoperative sensitivity
|
Follow up at intervals of 3, 6, 9 and 12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Patient satisfaction |
At the end of 12 months |
|
|
Target Sample Size
|
Total Sample Size="18"
Sample Size from India="18"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
25/09/2024 |
| 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="6"
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 - NO
|
|
Brief Summary
|
- Ceramic veneers are the hallmark of aesthetic restorations especially in cases of anterior teeth fracture. Unlike traditional crowns, which require significant tooth reduction, veneers necessitate only minimal enamel removal, preserving the majority of natural tooth structure.
- This study thus attempts to maintain the concept of "minimal preparation" and clinically assess the longevity and adaptation of partial ceramic veneer in comparison to conventional ceramic veneer for cases requiring restoration of anterior fractures.
|