| CTRI Number |
CTRI/2024/10/074555 [Registered on: 01/10/2024] Trial Registered Prospectively |
| Last Modified On: |
26/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Fit of temporary crown fabricated by machine vs manually |
|
Scientific Title of Study
|
Comparative Evaluation of Marginal Gap and Internal Fit in Provisional Crowns Fabricated by Conventional Technique and CAD CAM Milling 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 |
Aashish Rajesh Gupta |
| Designation |
PG Student |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
202, Department of Prosthodontics and Crown and Bridge, Sharad Pawar Dental College, Datta Meghe Institute of Higher Education and Research, Sawangi Meghe, Wardha, Maharashtra, India 442001
Wardha
MAHARASHTRA
442001
India |
| Phone |
9930120339 |
| Fax |
|
| Email |
aashishg470@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mithilesh Dhamande |
| Designation |
Reader |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
202, Department of Prosthodontics and Crown and Bridge, Sharad Pawar Dental College, Datta Meghe Institute of Higher Education and Research, Sawangi Meghe, Wardha, Maharashtra, India 442001
Wardha
MAHARASHTRA
442001
India |
| Phone |
9890590584 |
| Fax |
|
| Email |
miths_d@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mithilesh Dhamande |
| Designation |
Reader |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
202, Department of Prosthodontics and Crown and Bridge, Sharad Pawar Dental College, Datta Meghe Institute of Higher Education and Research, Sawangi Meghe, Wardha, Maharashtra, India 442001
Wardha
MAHARASHTRA
442001
India |
| Phone |
9890590584 |
| Fax |
|
| Email |
miths_d@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Datta Meghe Institute of Higher Education and Research, Wardha, India 442001 |
|
|
Primary Sponsor
|
| Name |
Datta Meghe Institute of Higher Education and Research |
| Address |
Sharad Pawar Dental College, Datta Meghe Institute of Higher Education and Research, Sawangi Meghe, Wardha, Maharashtra, India 442001 |
| Type of Sponsor |
Private 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 Aashish Gupta |
Sharad Pawar Dental College |
202, Department of Prosthodontics and Crown and Bridge, Sharad Pawar Dental College, Datta Meghe Institute of higher Education and Resarch, sawangi Meghe, Wardha , Maharashtra, India 442001
Wardha
MAHARASHTRA |
9930120339
aashishg470@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Datta Meghe Institute of Higher Education and Resarch |
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 |
| Intervention |
Provisional crown by Computer aided designing and Computer aided manufacturing technique |
Provisional crown fabricated from Computer aided designing and Computer aided manufacturing technique using PEEK and Telio CAD Temp given for 8-10 days |
| Comparator Agent |
Provisional crown by conventional method |
Provisional crown fabricated from conventional method using Protemp TM-4 given for 8-10 days |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients in need of crown over permanent mandibular 1st molar are selected. |
|
| ExclusionCriteria |
| Details |
Patient with age group below 15 years. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Provisional crowns made by CAD CAM milling fabrication method will have better marginal and internal fit than conventional method. |
Assessment will be done at the end of 12 month. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
NA |
|
|
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
01/10/2024 |
| 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="6"
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
|
The
provisional crown is an interim restoration that is used till definitive restoration is being fabricated. The
development of CAD-CAM methods have revolutionized the dental laboratory industry. Clinically
accepted maximum marginal gap till 150 µm to be clinically tolerable. The internal fit comprises the axial and the occlusal cement thickness. The aim of this study
was to compare the marginal gap and internal fit of provisional crowns made by
CAD/CAM milling technique and by conventional method. A total of 45 participants (15 per group) needing a single crown
restoration on permanent mandibular 1st molar tooth will be
selected. For
participant in Group A (n=15) provisional crowns will be made from ProtempTM4
using conventional hand technique. In group B (n=15) and group C (n=15)
provisional crown will be made from PEEK and Telio CAD Temp respectively and
both will be fabricated by using CAD CAM milling technique. |