| CTRI Number |
CTRI/2021/06/034204 [Registered on: 11/06/2021] Trial Registered Prospectively |
| Last Modified On: |
10/06/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Implant based replacement of missing tooth |
|
Scientific Title of Study
|
Comparing the biomechanical features of new dental implant system with standardized implant |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Amit Bhandari |
| Designation |
Head |
| Affiliation |
INMAS |
| Address |
Department of Dental Research and Implantology
Institute of Nuclear Medicine and Allied Science
Brig S. K. Mazumdar Marg
Timarpur
North West
DELHI
110054
India |
| Phone |
8638175651 |
| Fax |
|
| Email |
amitbhandari1093@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Amit Bhandari |
| Designation |
Head |
| Affiliation |
INMAS |
| Address |
Department of Dental Research and Implantology
Institute of Nuclear Medicine and Allied Science
Brig S. K. Mazumdar Marg
Timarpur
North West
DELHI
110054
India |
| Phone |
8638175651 |
| Fax |
|
| Email |
amitbhandari1093@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Amit Bhandari |
| Designation |
Head |
| Affiliation |
INMAS |
| Address |
Department of Dental Research and Implantology
Institute of Nuclear Medicine and Allied Science
Brig S. K. Mazumdar Marg
Timarpur
North West
DELHI
110054
India |
| Phone |
8638175651 |
| Fax |
|
| Email |
amitbhandari1093@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
INMAS DRDO |
| Address |
Department of Dental Research and Implantology
Brig S K Mazumdar Marg
Timarpur
Delhi 110054 |
| Type of Sponsor |
Research institution |
|
|
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 Amit Bhandari |
Institute of Nuclear Medicine and Allied Sciences |
Department of Dental Research and Implantology
Room No. 104
Brig S K Mazumdar Marg
Timarpur
North West
DELHI |
8638175651
amitbhandari1093@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INMAS Institutional Human Ethical Committee |
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 |
Dental implant-based rehabilitation |
Missing tooth will be rehabilitated using the commercially available standard dental implant system. |
| Intervention |
New Dental Implant System |
Missing tooth will be rehabilitated using the new dental implant system. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patient requiring replacement of one or more teeth and can be rehabilitated using dental implant based having a minimum mesiodistal width of 7mm in the edentulous region based on clinical and orthopantogram assessment. |
|
| ExclusionCriteria |
| Details |
Patients not willing to participate in the study.
Active smokers.
Patients with systemic diseases like diabetes. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
ISQ measurement
Clinical assessment
Radiographic assessment |
0 month
1 month
6 months
12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Clinical assessment
Radiographic assessment |
0 month
1 month
6 months
12 months |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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 |
|
Date of First Enrollment (India)
|
01/07/2021 |
| 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="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The study is focused on implant-based rehabilitation of missing tooth using the new dental implant system. In the two patient groups, one group will be rehabilitated using standard, commercially available implants while the other group will be rehabilitated using the new system. Patient will be blinded to the implant system used. All the implants will undergo loading after 1 month and sequential assessments of ISQ value, clinical and radiographic parameters after 1, 6 and 12 months respectively. |