| CTRI Number |
CTRI/2024/01/061842 [Registered on: 25/01/2024] Trial Registered Prospectively |
| Last Modified On: |
23/01/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to compare wear of two different crown materials and natural teeth |
|
Scientific Title of Study
|
Comparative evaluation of occlusal wear of polished CAD CAM fabricated translucent zirconia, polished heat pressed lithium disilicate crowns and natural antagonist enamel – a split mouth pilot 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 |
PoovithaM |
| Designation |
Junior Resident |
| Affiliation |
All India Institute of Medical Sciences New Delhi |
| Address |
2 nd Floor, Department of Prosthodontics Centre for Dental
Education and Research All India Institute of Medical Sciences New Delhi 110029
New Delhi
DELHI
110029
India |
| Phone |
7339240888 |
| Fax |
|
| Email |
poovithamohan99@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Veena Jain |
| Designation |
Head of the Department and Professor |
| Affiliation |
All India Institute of Medical Sciences New Delhi |
| Address |
2 nd Floor Department of Prosthodontics Centre for Dental
Education and Research, All India Institute of Medical Sciences New Delhi 110029
New Delhi
DELHI
110029
India |
| Phone |
9868187441 |
| Fax |
|
| Email |
jainveena1@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Poovitha M |
| Designation |
Junior Resident |
| Affiliation |
All India Institute of Medical Sciences New Delhi |
| Address |
2 nd Floor Department of Prosthodontics Centre for Dental
Education and Research All India Institute of Medical Sciences New Delhi 110029
New Delhi
DELHI
110029
India |
| Phone |
07339240888 |
| Fax |
|
| Email |
poovithamohan99@gmail.com |
|
|
Source of Monetary or Material Support
|
| Poovitha M,Junior Resident,Department of Prosthodontics,Centre for Dental Education and Research,AIIMS,New Delhi |
|
|
Primary Sponsor
|
| Name |
Poovitha.M |
| Address |
2 nd Floor, Department of Prosthodontics Centre for Dental
Education and Research All India Institute of Medical Sciences New Delhi 110029 |
| Type of Sponsor |
Other [SELF] |
|
|
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 Poovitha M |
Centre for Dental Education and Research AIIMS New Delhi |
Department of Prosthodontics
2nd floor
New Delhi
DELHI |
07339240888
poovithamohan99@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee ,AIIMS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K030||Excessive attrition of teeth, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Endodontically treated teeth restored with lithium disilicate crown |
Tooth preparation done in endodontically treated mandibular 1st molar and cemented with lithium disilicate crown and evaluated for wear of crown and the antagonist natural enamel 24 hours after cementation and 1 year after cementation |
| Comparator Agent |
Endodontically treated teeth restored with translucent zirconia crown |
Tooth preparation done in endodontically treated mandibular 1st molar and cemented with translucent zirconia crown and evaluated for wear of crown and the antagonist natural enamel 24 hours after cementation and 1 year after cementation |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients requiring bilateral posterior maxillary or mandibular complete crowns.
2.Teeth selected for zirconia crown preparation should be restorable with a minimum crown to root ratio of at least 1:1.
3.Teeth with healthy opposing natural teeth.
4.Patients with good oral hygiene and periodontal status.
5.Patients with full complement of teeth (excluding 3rd molars).
6.Patients who will be available for the required follow up period.
7.Patients giving positive informed consent.
8.Patient in age group 18-45 years will be enrolled
|
|
| ExclusionCriteria |
| Details |
1.Patients with developmental defects of enamel and dentin.
2.Parafunctional habits like bruxism, clenching.
3.Temporomandibular joint disorders.
4.Patients with fluorosis, calcium metabolic disorders, osteoporosis.
5.Opposing teeth with caries or wear
6.Patients having malocclusion
|
|
|
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 |
To evaluate the occlusal wear of polished translucent zirconia and polished heat pressed lithium disilicate crowns by natural antagonistic teeth in micro meters
2.To evaluate the occlusal wear of natural antagonistic enamel by polished translucent zirconia and polished heat pressed lithium disilicate crowns in micro meters
|
24 hours after cementation and 1 year after cementation of crown |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To evaluate the occlusal wear of natural enamel antagonistic with natural enamel(control).
2.To compare the wear of polished translucent zirconia, polished lithium disilicate crowns, and natural enamel with each other and with control.
|
24 hours after cementation and 1 year after cementation of crown |
|
|
Target Sample Size
|
Total Sample Size="12"
Sample Size from India="12"
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)
|
02/02/2024 |
| 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="10"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Wear is the gradual
removal of material from surfaces as the result of mechanical or chemical
injuries, it can occur through 3 processes erosion attrition and abrasion. Various studies have evaluated the
wear of translucent monolithic zirconia and lithium disilicate against natural
teeth in laboratory (in vitro) and clinical studies but up to best of our
knowledge clinical studies evaluating the wear of CAD CAM fabricated
translucent zirconia and heat pressed lithium disilicate against natural enamel
is not present . Therefore this study compares and evaluates the occlusal wear of polished CAD CAM fabricated translucent zirconia polished heat pressed lithium disilicate crowns and natural antagonist enamel 24 hours after cementation and 1 year after cementation. |