| CTRI Number |
CTRI/2024/07/069715 [Registered on: 01/07/2024] Trial Registered Prospectively |
| Last Modified On: |
27/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Assessment of zygomatic bone radioraphically-A cross sectional study |
|
Scientific Title of Study
|
Radiomorphometric assessment of zygoma in optimisation of planning zygomatic implants-A cross sectional 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 |
Nagaraju |
| Designation |
Post graduate |
| Affiliation |
Anil Neerukonda Institute of Dental Sciences |
| Address |
Anil Neerukonda Institute of Dental Sciences, Department of Oral and maxillofacial surgery, Room no - 3 Sangivalasa , Visakhapatnam.
Visakhapatnam
ANDHRA PRADESH
531162
India |
| Phone |
9912484684 |
| Fax |
00000000 |
| Email |
chnr99124@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr K Phanikumar |
| Designation |
Professor and Head of the Department |
| Affiliation |
Anil Neerukonda Institute of Dental Sciences |
| Address |
Anil Neerukonda Institute of Dental Sciences, Department of Oral and Maxillofacial Surgery, Room No 3 Sangivalasa, Visakhapatnam.
Visakhapatnam
ANDHRA PRADESH
531162
India |
| Phone |
8096339404 |
| Fax |
00000000 |
| Email |
raghu8099@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr V V R Murthy |
| Designation |
Professor |
| Affiliation |
Anil Neerukonda Institute of Dental Sciences |
| Address |
Anil Neerukonda Institute of Dental Sciences,Department of oral and Maxillofacial Surgery, Room no 03, Sangivalasa, Visakhapatnam.
Visakhapatnam
ANDHRA PRADESH
531162
India |
| Phone |
984959801 |
| Fax |
00000000 |
| Email |
murthymaxfac@gmail.com |
|
|
Source of Monetary or Material Support
|
| Anil Neerukonda Institute of Dental Sciences, Sangivalasa, Visakhapatnam. Pin code: 531162 |
|
|
Primary Sponsor
|
| Name |
Anil Neerukonda Institute of Dental Sciences |
| Address |
Anil Neerukonda Institute of Dental Sciences, Sangivalasa, Visakhapatnam. |
| Type of Sponsor |
Research institution and hospital |
|
|
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 NAGARAJU CHILAKA |
DEPARTMENT OF OMFS, ROOM NO 03,ANIL NEERUKONDA INSTITUTE OF DENTAL SCIENCES |
ANIL NEERUKONDA INSTISTUTE OF DENTAL SCIENCES, SANGIVALASA,VISAKHAPATNAM 531162
Visakhapatnam
ANDHRA PRADESH |
9912484684
chnr99124@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, ANIDS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Non-Immunocompromised |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Dr. CH Nagaraju |
Post graduate,
Anil Neerukonda Institute of Dental Sciences. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
CT data of any apparently healthy zygoma in DICOM format, preferably with a section slicing of less than 1mm. |
|
| ExclusionCriteria |
| Details |
CT DICOM data of those zygomas which are affected either by trauma, pathology or infection.
CT DICOME data of those patients with history of previously failed zygomatic implants.
CT DICOM data of those zygomas with at least one zygomatic implant placed in it. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Precise and accurate placement of zygomatic implants.
Preventing complications that might arise from improper planning.
Providing graft less solutions for complex maxillary rehabilitation. |
18 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Precise and accurate placement of zygomatic implants.
Preventing complications that might arise from improper planning.
Providing graft less solutions for complex maxillary rehabilitation. |
20 months |
To restore the lost tooth, form & function
Rehabilitation of patient with newly placed implants & improve the confidence of the patient. |
24 months |
|
|
Target Sample Size
|
Total Sample Size="125"
Sample Size from India="125"
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
|
N/A |
|
Date of First Enrollment (India)
|
27/08/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
27/08/2024 |
| 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 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
|
In this study focusing on volumetric and density considerations in zygomatic implants is essential to address this knowledge gap and enhance clinical practice. This research endeavours to improve the precision and predictability of Zygomatic implant placement, ultimately benefiting patients with complex Maxillofacial rehabilitation |