| CTRI Number |
CTRI/2024/07/070134 [Registered on: 07/07/2024] Trial Registered Prospectively |
| Last Modified On: |
26/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing Strut-Retained and Screw-Retained Patient-Specific Implants in Post-COVID Mucormycosis Maxillectomy Defect Rehabilitation |
|
Scientific Title of Study
|
Evaluation of Strut retained versus Screw retained patient specific implants in rehabilitation of post COVID mucormycosis maxillectomy Defects. A randomized controlled trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Navinkumar Shankurwar |
| Designation |
PG STUDENT |
| Affiliation |
Government Dental College and Hospital, Nagpur. |
| Address |
Room No 106, Department of Oral and Maxillofacial Surgery, Government Dental College and Hospital, Nagpur 440003.
Nagpur
MAHARASHTRA
440003
India |
| Phone |
7038279107 |
| Fax |
|
| Email |
dentogem03@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Navinkumar Shankurwar |
| Designation |
PG STUDENT |
| Affiliation |
Government Dental College and Hospital, Nagpur. |
| Address |
Room No. 106, Department of Oral and Maxillofacial Surgery, Government Dental College and Hospital, Nagpur 440003.
Nagpur
MAHARASHTRA
440003
India |
| Phone |
7038279107 |
| Fax |
|
| Email |
dentogem03@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrAbhay Datarkar |
| Designation |
Professor and Dean |
| Affiliation |
Government Dental College and Hospital, Nagpur. |
| Address |
Dept. of Oral and Maxillofacial surgery, Government Dental College and
Hospital, Nagpur, Govt. Medical Campus, Hanuman Nagar, Nagpur
Nagpur
MAHARASHTRA
440003
India |
| Phone |
9822698145 |
| Fax |
|
| Email |
abhaydatarkar@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Government Dental College and Hospital, Nagpur 440003, Maharashtra, India. |
|
|
Primary Sponsor
|
| Name |
NAVINKUMAR SHANKURWAR |
| Address |
Room no.106, Department of Oral and Maxillofacial surgery, Government Dental College and Hospital, Nagpur 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 Navinkumar Shankurwar |
GOVERNMENT DENTAL COLLEGE AND HOSPITAL NAGPUR |
Room No. 106, Department of Oral and Maxillofacial Surgery, First Floor, Government Dental College and Hospital, Nagpur 440003
Nagpur
MAHARASHTRA |
7038279107
dentogem03@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| GOVERNMENT DENTAL COLLEGE AND HOSPITAL NAGPUR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K088||Other specified disorders of teethand supporting structures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Surgical rehabilitation of post covid mucormycosis maxillectomy defect using screw retained patient specific implant under general anesthesia |
Patient will be operated under general anesthesia and screw retained patient specific implant will be placed at the time of surgery for rehabilitation of post covid mucormycosis maxillectomy defect followed by dental prosthesis fabrication over the implant after one month. |
| Comparator Agent |
Surgical rehabilitation of post covid mucormycosis maxillectomy defect using strut retained patient specific implant under general anesthesia |
Patient will be operated under general anesthesia and strut retained patient specific implant will be placed at the time of surgery for rehabilitation of post covid mucormycosis maxillectomy defect followed by dental prosthesis fabrication over the implant after one month. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients with post covid mucormycosis maxillectomy defect.
2. Good general health status.
3. Patient with good bone support and soft tissue in the area intended for implant placement.
4. Patient with good oral hygiene and motivation.
|
|
| ExclusionCriteria |
| Details |
1. Poor oral hygiene and motivation.
2. Patients with systemic immunocompromised conditions.
3. Acute or chronic infection/inflammation in the area intended for implant placement.
4. Patients with habit of smoking, kharra chewing, tobacco chewing.
5. Para-functional habits.
6. Radiotherapy to the head and neck region
7. Patient on bisphosphonate therapy.
8. Unable to attend follow-up visits.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Quality of life
Ease of prosthesis fabrication |
post operatively 1 week 1 month 3 month 6 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Ease of surgery
Intra operative time
Level of hygiene
|
post operatively 1 week 1 month 3 month 6 month |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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)
|
09/08/2024 |
| 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="1"
Months="6"
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
|
This randomized controlled trial
compares the effectiveness of two types of patient-specific implants in
rehabilitating maxillectomy defects resulting from post-COVID mucormycosis. The
study evaluates the outcomes of using both strut-retained and screw-retained
implants in this context. By assessing factors such as quality of life, ease of
surgery , ease of prosthesis fabrication, aesthetic outcomes, and patient
satisfaction, the research aims to provide insights into the optimal approach
for restoring maxillectomy defects in individuals affected by post-COVID
mucormycosis.
Tailored patient-specific
implants (PSIs) represent a precise solution for facial reconstruction, with
two main types available: PSI with struts (PSI 1) and PSI with screw-retained
implants embedded within (PSI 2). Computer surgical planning is crucial for
this process, enabling surgeons to strategize and adjust defects and flaps with
unobstructed 3D visualization. Integration of 3D-printed cutting guides, based
on computer-generated plans, simplifies complex closing osteotomies,
effectively translating virtual designs into real-world surgery. Compared to
traditional implants, PSIs offer heightened accuracy, superior site adaptation,
and reduced operating time. This transformative technology signifies a
significant advancement in maxillofacial surgery, providing a more precise,
efficient, and patient-tailored approach to reconstruction.
This study is planned in
department of oral and maxillofacial surgery Government dental college and
hospital Nagpur To
evaluate and compare the effectiveness of Strut-Retained and Screw-Retained
Patient-Specific Implants in rehabilitation of post covid mucormycosis
maxillectomy defect. Primary research question What is the comparative effectiveness of
Strut-Retained and Screw-Retained Patient-Specific Implants in the
rehabilitation of Post-COVID Mucormycosis maxillectomy defects ? Null hypothesis : There is no difference in strut retained and screw
retained patient specific implants in rehabilitating post covid mucormycosis
maxillectomy defect Alternative hypothesis : There is difference in strut retained and screw
retained patient specific implants in rehabilitating post covid mucormycosis
maxillectomy defect.
|