| CTRI Number |
CTRI/2023/09/058161 [Registered on: 29/09/2023] Trial Registered Prospectively |
| Last Modified On: |
14/09/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Other |
|
Public Title of Study
|
Comparison Of Different Veneers |
|
Scientific Title of Study
|
Clinical Assessment Of Direct Composite Veneer And Indirect Veneers Using Minimally Invasive Preparation Technique - An In Vivo 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 |
Patel Komalben Pankajbhai |
| Designation |
PG student |
| Affiliation |
Government dental college and hospital ,ahmedabad |
| Address |
room no 9,department of conservative dentistry and endodontics,govt dental college and hospital,civil hospital campus,asarwa,ahmedabad
Ahmadabad
GUJARAT
380016
India |
| Phone |
9904095409 |
| Fax |
|
| Email |
komal58patel@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Girish Parmar |
| Designation |
Dean(Additional Director) |
| Affiliation |
Government Dental College and Hospital ,Ahmedabad |
| Address |
Department of Conservative dentistry and Endodontics,Govt Dental College and Hospital, Civil Hospital Campus, Asarwa ,Ahmedabad.
Ahmadabad
GUJARAT
380016
India |
| Phone |
9426006569 |
| Fax |
|
| Email |
drgjp@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Patel Komalben Pankajbhai |
| Designation |
PG student |
| Affiliation |
Government dental college and hospital ,ahmedabad |
| Address |
room no 9,department of conservative dentistry and endodontics,govt dental college and hospital,civil hospital campus,asarwa,ahmedabad
Ahmadabad
GUJARAT
380016
India |
| Phone |
9904095409 |
| Fax |
|
| Email |
komal58patel@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of conservative dentistry and endodontics,government dental college and hospital,civil hospital campus,asarwa,ahmedabad,380016 |
|
|
Primary Sponsor
|
| Name |
Government Dental College and Hospital Ahmedabad |
| Address |
Government Dental College and Hospital ,Civil Hospital Campus ,Asarwa ,Ahmedabad ,380016 |
| Type of Sponsor |
Government medical college |
|
|
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 Komal Patel |
Government Dental College and Hospital,Ahmedabad |
Room no 9,Department of Conservative Dentistry and Endodontics,Government Dental College and Hospital,Civil Hospital Campus ,Asarwa
Ahmadabad
GUJARAT |
9904095409
komal58patel@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Government Dental College and Hospital ,Ahmedabad |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K037||Posteruptive color changes of dental hard tissues, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Composite and Ceramic Veneers |
In Patients having Discoloured Teeth ,Direct Composite Veneers,Indirect Composite Veneers and Indirect Ceramic Veneers will be done and will be evaluated at 3,6 and 12 months. |
| Comparator Agent |
Modified USPHS Criteria |
In Patients having Discolored Teeth Direct composite veneers,Indirect composite veneers and Indirect ceramic veneers will be done and will be evaluated at 3,6 and 12 months using modified USPHS criteria for marginal discoloration, caries, post operative sensitivity and fracture of tooth and restoration. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Good oral hygiene
Correction of malposed anterior teeth not requiring extensive orthodontic treatment
Traumatized anterior teeth correctable by veneers
Nonvital discoloured teeth
Mismatched shade or fracture veneers or composite restorations
Discoloured teeth (tetracycline and fluorosis stain)
Mild to moderate diastema (1-2mm)
Tooth dysplasia and hypoplasia.
|
|
| ExclusionCriteria |
| Details |
Requiring extensive orthodontic treatment for correction of diastema, malalignment, and deep bite
severe untreated bruxism
Rampant caries
poor oral hygiene
chronic smokers
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Indirect ceramic veneers can be used as effective esthetic treatment of discolored teeth to achieve lesser marginal discoloration,caries ,post operative sensitivity,fracture of restoration & fracture of tooth. |
the outcome will be assessed after 3 months,6 months & 12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The outcome of indirect veneers are better than direct veneers with lower incidence of marginal discoloration & post operative sensitivity. |
the outcome will be assessed after 3 months,6months & 12months |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
30/09/2023 |
| 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="2"
Months="0"
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
|
There is an ever increasing demand for better results in anterior esthetic corrections. Recent
advances in adhesive dentistry has led to the development of new materials and techniques
specifically aimed at improving the esthetic results of anterior teeth.
AIM : The aim of this study is to evaluate the clinical behavior of direct composite veneer, indirect
composite veneer and indirect ceramic veneer.
OBJECTIVE
The purpose of this study is To compare the clinical performance of direct composite veneer, indirect composite veneer and
indirect ceramic veneer for marginal discoloration, caries ,post operative sensitivity, fracture of restoration and fracture of tooth. |