| CTRI Number |
CTRI/2023/06/054161 [Registered on: 20/06/2023] Trial Registered Prospectively |
| Last Modified On: |
18/06/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of Performance of Two Different 3D Printed Definitive Resin Dental Crowns with Pressed Lithium Disilicate Dental Crowns in Patients |
|
Scientific Title of Study
|
Comparative Evaluation of Clinical Performance of Two Different 3D Printed Definitive Resin Crowns with Pressed Lithium Disilicate Crowns |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Jyot Kaur Kohli |
| Designation |
Post Graduate Student |
| Affiliation |
SDM College of Dental Sciences and Hospital, Dharwad |
| Address |
Department of Prosthodontics and Crown and Bridge,
SDM College of Dental Sciences and Hospital
Dharwad
KARNATAKA
580009
India |
| Phone |
9958216402 |
| Fax |
|
| Email |
jyotkohli28@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Satyabodh Guttal |
| Designation |
Professor |
| Affiliation |
SDM College of Dental Sciences and Hospital, Dharwad |
| Address |
Department of Prosthodontics and Crown and Bridge,
SDM College of Dental Sciences and Hospital
Dharwad
KARNATAKA
580009
India |
| Phone |
|
| Fax |
|
| Email |
drsatyabodh@sdmuniversity.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jyot Kaur Kohli |
| Designation |
Post Graduate Student |
| Affiliation |
SDM College of Dental Sciences and Hospital, Dharwad |
| Address |
Department of Prosthodontics and Crown and Bridge,
SDM College of Dental Sciences and Hospital
Dharwad
KARNATAKA
580009
India |
| Phone |
|
| Fax |
|
| Email |
jyotkohli28@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Prosthodontics and Crown and Bridge,
SDM College of Dental Sciences and Hospital,
Dharwad,
Karnataka,
580009 |
| Saremco Dental AG, Gewerbestrasse 4,
CH-9445,
Rebstein |
|
|
Primary Sponsor
|
| Name |
Dr Jyot Kaur Kohli |
| Address |
Department of Prosthodontics and Crown and Bridge,
SDM College of Dental Sciences and Hospital,
Dharwad,
Karnataka,
580009 |
| 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 Jyot Kaur Kohli |
SDM College of Dental Sciences and Hospital, Dharwad |
Room 11B, Department of Prosthodontics and Crown and Bridge, SDM College of Dental Sciences and Hospital
Dharwad
KARNATAKA |
9958216402
jyotkohli28@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SDMCDSH-IEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K038||Other specified diseases of hard tissues of teeth, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Lithium Disilicate |
Pressed lithium disilicate crowns |
| Intervention |
Permanent nano-filled ceramic resin (Brand 1) |
Nano-filled ceramic resin for 3D printing of definitive dental crowns and bridges will be used to fabricate permanent dental crowns. They will be followed up till 9 months after cementation. |
| Intervention |
Permanent nano-filled ceramic resin (Brand 2) |
Nano-filled ceramic resin for 3D printing of definitive dental crowns and bridges will be used to fabricate permanent dental crowns. They will be followed up till 9 months after cementation. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
a) Vital/Non-vital tooth in posterior segment
b) Periodontally healthy with no signs of bone resorption or periapical pathology
c) Tooth with adequate occluso-gingival height according to the principles of tooth preparation
d) Complete complement of teeth in the opposing arch
e) Capable of signing an informed consent
|
|
| ExclusionCriteria |
| Details |
a) Poor oral hygiene
b) Clinical history of bruxism
c) Crown or fixed partial denture on the opposing tooth
d) Pregnant or lactating females
|
|
|
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 |
| Restorations will be evaluated at recall intervals of 3 months, 6 months and 9 months using Modified Ryge’s criteria for anatomical form, restoration staining, marginal discoloration, color match, surface roughness, marginal adaptation and periodontal status. Comparison of proportion of success between groups will be done by chi-square test; p value less than 0.05 will be considered as statistically significant. |
9 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Restorations will be evaluated at recall intervals of 3 months, 6 months and 9 months using Modified Ryge’s criteria for anatomical form, restoration staining, marginal discoloration, color match, surface roughness, marginal adaptation and periodontal status |
3 months, 6 months |
|
|
Target Sample Size
|
Total Sample Size="45"
Sample Size from India="45"
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)
|
03/07/2023 |
| 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
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
· Objectives: 1. To clinically evaluate
the performance of two 3D printed resin crowns as long-term definitive
restorations
· 2. To
clinically evaluate the performance of 3D printed resin crowns as compared to
pressed lithium disilicate crowns as long-term definitive restorations with
respect to anatomic form, restoration staining, marginal discoloration, color
match, surface roughness, marginal adaptation, and periodontal status of the
teeth
· Hypothesis:
There will be no differences between the 3D printed resin crowns and pressed
lithium disilicate crowns in terms of longevity of the restorations. |