| CTRI Number |
CTRI/2024/04/066074 [Registered on: 22/04/2024] Trial Registered Prospectively |
| Last Modified On: |
20/04/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of loss of CAD-CAM crown surface and opposing natural teeth surface. |
|
Scientific Title of Study
|
Comparative evaluation of occlusal wear of CAD-CAM fabricated Zirconia, Zirconia-reinforced Lithium Silicate, Graphene crowns and their antagonist natural teeth at three different time intervals. A Prospective 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 |
Dr Yogesh S Ingole |
| Designation |
Assistant Professor |
| Affiliation |
Government Dental College and Hospital, Nagpur. |
| Address |
Department of Prosthodontics and Crown & Bridge, Government Dental College and Hospital, Medical Campus, Medical Square, Nagpur.
Nagpur
MAHARASHTRA
440003
India |
| Phone |
9960568700 |
| Fax |
|
| Email |
dr.ysingole@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Yogesh S Ingole |
| Designation |
Assistant Professor |
| Affiliation |
Government Dental College and Hospital, Nagpur. |
| Address |
Department of Prosthodontics and Crown & Bridge, Government Dental College and Hospital, Medical Campus, Medical Square, Nagpur.
Nagpur
MAHARASHTRA
440003
India |
| Phone |
9960568700 |
| Fax |
|
| Email |
dr.ysingole@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Yogesh S Ingole |
| Designation |
Assistant Professor |
| Affiliation |
Government Dental College and Hospital, Nagpur. |
| Address |
Department of Prosthodontics and Crown & Bridge, Government Dental College and Hospital, Medical Campus, Medical Square, Nagpur.
Nagpur
MAHARASHTRA
440003
India |
| Phone |
9960568700 |
| Fax |
|
| Email |
dr.ysingole@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Prosthodontics and Crown and Bridge, Government Dental College and Hospital, Medical Campus, Medical Square, Nagpur, Maharashtra, India. 440003 |
|
|
Primary Sponsor
|
| Name |
Dr Yogesh S Ingole |
| Address |
Government Dental College and Hospital, Medical Campus, Medical Square, Nagpur, Maharashtra, India. 440003. |
| 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 Yogesh S Ingole |
Government Dental College and Hospital, Nagpur. |
Room No. 13, Department of Prosthodontics, Government Dental College and Hospital, Medical Campus, Medical Square, Nagpur 440003, Maharashtra, India.
Nagpur
MAHARASHTRA |
9960568700
dr.ysingole@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| VSPMs Dental College and Research Centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy human volunteers requiring crowns on
first molar teeth. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Graphene |
Graphene crowns will be cemented and occlusal wear against opposing teeth will be calculated for a period of eighteen months. Occlusal Wear between natural teeth will be taken as a control in the study. Total Duration of study will be 2 years. |
| Comparator Agent |
NA |
NA |
| Intervention |
Zirconia |
Zirconia crowns will be cemented and occlusal wear against opposing teeth will be calculated for a period of eighteen months.
Occlusal Wear between natural
teeth will be taken as a control in the study.
Total Duration of study will be 2 years. |
| Intervention |
Zirconia-reinforced Lithium Silicate |
Zirconia-reinforced Lithium Silicate crowns will be cemented and occlusal wear against opposing teeth will be calculated for a period of eighteen months. Occlusal Wear between natural teeth will be taken as a control in the study. Total Duration of study will be 2 years. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
a) Age: 18 to 50 years
b) Endodontically treated Tooth#16, tooth#26, tooth#36 or tooth#46 requiring full coverage crown.
c) Healthy, unrestored opposing natural teeth
d) Fully dentate patients showing canine-guided occlusion
e) Willing patients |
|
| ExclusionCriteria |
| Details |
a) Age less than 18 years and more than 50 years
b) Missing or restored opposing natural teeth
c) Opposing teeth with partial or complete denture prosthesis
d) Opposing implant-supported restorations
e) Patients showing signs of developmental enamel defects, fluorosis, parafunctional habits, temporomandibular joint disorders and osteoporosis.
f) Patients showing occlusal discrepancies like attrition, abrasion.
g) Patients undergoing orthodontic treatment.
h) Medically compromised patients.
i) Un-willing patients. |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
The occlusal wear of CAD-CAM fabricated
Zirconia, Zirconia-reinforced Lithium Silicate
(ZLS), Graphene crowns and their antagonist
natural teeth at three different time intervals. |
The occlusal wear of CAD-CAM fabricated
Zirconia, Zirconia-reinforced Lithium Silicate
(ZLS), Graphene crowns and their antagonist
natural teeth at three different time intervals, i.e. at baseline, 6 months, 12 months, and 18 months period. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
The change in occlusal contact area distribution
between CAD-CAM fabricated Zirconia,
Zirconia-reinforced Lithium Silicate (ZLS),
Graphene crowns & their antagonist natural
teeth at three different time intervals. |
The change in occlusal contact area distribution
between CAD-CAM fabricated Zirconia,
Zirconia-reinforced Lithium Silicate (ZLS),
Graphene crowns & their antagonist natural
teeth at three different time intervals, i.e. at baseline, 6 months, 12 months, & 18 months period. |
|
|
Target Sample Size
|
Total Sample Size="75"
Sample Size from India="75"
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 4 |
|
Date of First Enrollment (India)
|
02/05/2024 |
| 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="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
|
The computer-aided design computer-aided manufacturing (CAD-CAM) systems have been advanced dramatically over the last two decades. Recently, technological developments in CAD-CAM systems have enabled clinicians and dental laboratories to manufacture various kinds of restorations using different materials. Wear of tooth structure is a natural unavoidable process which occurs when tooth and tooth, or tooth and restoration are in contact and slide against each other. However, this natural process may be accelerated by the introduction of restorations whose properties of wear differ from those of the tooth structure that they slide against. So, this study evaluates the in-vivo wear of different CAD-CAM fabricated crowns and their antagonists; which may influence the occlusal contact areas between these occluding surfaces. |