| CTRI Number |
CTRI/2018/02/012241 [Registered on: 28/02/2018] Trial Registered Retrospectively |
| Last Modified On: |
27/02/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparative evaluation of wear of two types of crowns and opposing natural teeth. |
|
Scientific Title of Study
|
Comparative evaluation of the wear of Glazed Zirconia crowns, Polished Zirconia crowns and Opposing natural teeth.- An invivo study. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
uvashri s |
| Designation |
junior resident |
| Affiliation |
CDER, AIIMS. |
| Address |
2nd floor, Department of Prosthodontics,
CDER, AIIMS,New Delhi.
.
New Delhi
DELHI
New delhi- 110029
India |
| Phone |
9643973479 |
| Fax |
|
| Email |
uvashris@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
VEENA JAIN |
| Designation |
Head of the department |
| Affiliation |
CDER, AIIMS. |
| Address |
2nd floor, Department of Prosthodontics, CDER, AIIMS.
New Delhi
DELHI
New delhi- 110029
India |
| Phone |
9868187441 |
| Fax |
|
| Email |
jainveena1@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
VEENA JAIN |
| Designation |
Head of the department |
| Affiliation |
CDER, AIIMS. |
| Address |
Department of Prosthodontics, CDER, AIIMS.
New Delhi
DELHI
New delhi- 110029
India |
| Phone |
9868187441 |
| Fax |
|
| Email |
jainveena1@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of prosthodontics, 2nd floor, CDER, AIIMS |
|
|
Primary Sponsor
|
| Name |
CDER |
| Address |
CDER, AIIMS, NEW DELHI. |
| 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 |
| UVASHRI S |
Department of prosthodontics. |
2nd floor, Department of prosthodontics, CDER, AIIMS.
New Delhi
DELHI |
9643973479
uvashris@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTE ETHICS COMMITTEE FOR POST GRADUATE RESEARCH |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Patients requiring crowns in bilateral root canal treated teeth, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
glazed and polished zirconia crowns and opposing natural teeth |
wear of glazed, polished zirconia crowns and opposing natural teeth are measured in terms of occlusal surface area and volume immediately and 1 year after cementation of crowns. |
| Comparator Agent |
natural teeth opposing natural teeth |
wear of natural teeth opposing natural teeth is measured and compared with the intervention group |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Patients requiring bilateral posterior complete crowns.
Teeth with minimal crown to root ratio of atleast 1:1
Teeth with healthy opposing natural teeth.
Patients with good oral hygiene and periodontal status, with full complement of teeth(excluding 3rd molars),who will be available for required follow up period.
Patients giving positive informed consent. |
|
| ExclusionCriteria |
| Details |
Patients with developmental defects of enamel and dentin, parafunctional habits like bruxism, clenching.
Temperomandibular disorders,
Patients with fluorosis, calcium metabolic disorders, osteoporosis,etc.
Opposing teeth with caries or attrition
Patients having posterior crossbite. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
wear of glazed and polished zirconia crowns opposing natural
teeth |
1 year. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
evaluate the wear of natural teeth opposing polished and glazed zirconia
crowns
To compare the wear of glazed and polished zirconia crown with each other and
control |
1 year |
|
|
Target Sample Size
|
Total Sample Size="10"
Sample Size from India="10"
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 |
|
Date of First Enrollment (India)
|
04/12/2017 |
| 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="15" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
To improve the esthetic property of Zirconia crowns, they are either glazed or polished. There is in-vitro studies which compares the wear potential of glazed and polished zirconia crowns. But clinical scenario is different. Hence comparing the wear of glazed, polished zirconia crowns and opposing natural teeth is essential. |